T 1642/07 – Prophets Welcome

The applicant filed an appeal against the decision of the Examining Division (ED) refusing his application.

Independent claims 1 and 8 before the Board read:

1. A combination of a herpes simplex virus (HSV) and an effective amount of a chemotherapeutic agent which induces DNA damage for simultaneous, separate or sequential use in a method of treatment of the human or animal body.

8. Use of a herpes simplex virus (HSV) for the manufacture of a medicament for the therapy of tumors, wherein the virus is administered simultaneously, separately or sequentially in combination with an effective amount of a chemotherapeutic agent which induces DNA damage.

The Board found this request to comply with the requirements of A 123(2) and to be novel. It then determined document D3 to be the closest prior art and found that the problem to be solved over D3 was to provide an alternative potentiated virus-based combination therapy for killing (cancer) cells. The proposed solution lay in the replacement of radiation with a chemotherapeutic agent which induces DNA damage. 

The Board then dealt with the question whether the problem had indeed been solved:

[14] In the decision under appeal, the ED considered that the formulated technical problem had not been solved.

[15] However, as explained in detail below […], the ED’s negative arguments […] in relation to the failed solution of the technical problem do not (or no longer) apply to the formulation of the technical problem set out by the board. This formulation is now the provision of an alternative potentiated virus-based combination therapy (wherein “potentiated” means additive until synergistic, or in other words “at least additive”) […].

[16] One of the ED’s lines of argument […] was that the patent application as filed did not comprise experimental data showing the synergistic effect.

[17] Firstly, the board cannot agree with the approach adopted by the ED which unjustifiably turned its original formulation from “the provision of an alternative anticancer therapy using HSV” […] into “the provision of a synergistic anticancer combination therapy” […].

[18] Secondly, it is true that the patent application contains no experimental evidence in support of the claimed combination therapy but only theoretical statements that viral therapy in combination with a chemotherapeutic agent inducing DNA damage results in an additive until synergistic killing effect on cells/cancer cells […]. A “prophetic” Example III(3) disclosing mitomycin C at a dose of 20 mg/m**(2) to be used in conjunction with an adenovirus can also be found [… in] the published WO application. HSV viruses are dealt with […]. The patent application as filed thus addresses expressis verbis the claimed subject matter and potentiation (additive until synergistic killing effect on cells/cancer cells).

However, the board observes that there is no requirement in the EPC, let alone in A 56, that a patent application should include experimental evidence in support of patentability or a claimed technical effect. Hence, the fact that the disclosure in a patent application is merely theoretical and not supported by experimental data is in itself no bar to patentability or to the presence of a technical effect being acknowledged.

[19] Further, the ED, relying on decision T 1329/04, decided that post-published documents E7, E8 and E13 to E15 could not be taken into account for showing that the synergistic effect occurred, because the disclosure in the present application did not render plausible that its teaching indeed solved the problem of providing a synergistic anticancer combination therapy and did not render plausible that this synergistic effect occurred for all the possible combinations covered by claim 1.

[20] However, the formulation of the technical problem to be solved as set out by the board is less demanding than the ED’s, since it now only requires that the potentiating effect be additive until synergistic (in other words, “at least additive”) rather than “synergistic” for any combination.

Post-published document E7 (this document shows that HSV R1716 + mitomycin C = additive effect in 3/5 cells and synergistic effect in 2/5 cells and that HSV R3616 + cisplatin = additive effect), document E8 (HSV NV1066 + 5-FU or gemcitabine = synergistic effect in 3 cell lines), E13 (HSV NV1020 + 5-FU, SN38 or oxaliplatin = additive up to synergistic effect), document E14 (HSV NV1066 + cisplatin = synergistic effect in 6 cell lines) and document E15 (HSV NV1066 + mitomycin C = synergistic effect in 2 cell lines), submitted by the appellant, illustrate such an “at least additive” effect for all the combinations.

Therefore, the dichotomy noted by the ED between the disclosure in the patent application and the technical teaching in post-published documents E7, E8 and E13 to E15 no longer subsists. Rather, the post-published documents can be viewed as being a mere confirmation of the technical effect already announced (albeit at a theoretical level) in the application as filed.

[21] The board observes that such a dichotomy arose between, on the one hand, the disclosure in the patent application underlying decision T 1329/04 (lack of the seven cystein residues with their peculiar spacing required for a protein (in that case, GDF-9) to belong to the TGF-beta superfamily – see T 1329/04 [7] – and the lack of functional characterisation of GDF-9 – see ibidem, [9]) and, on the other hand, the teaching in post-published document D4 that GDF-9 was indeed a growth differentiation factor (see T 1329/04 [12]). Hence, the then competent board concluded that there was not enough evidence in the application as filed to make it at least plausible that a solution had been found to the problem alleged to be solved.

[22] In summary, the negative arguments produced by the ED no longer apply to the less demanding problem set out [by the board]. The board sees also no grounds for doubting that the combined administration of HSV and a chemotherapeutic agent inducing DNA damage is able to achieve an increase of the level of cell killing above that seen for a treatment modality alone. Under these circumstances, post-published documents E7, E8 and E23 to E15 can be taken into account.

[23] In view of the foregoing, the board concludes that the problem highlighted in point 13 supra has indeed been solved by the claimed subject-matter.

The Board then found the claims to be inventive and remitted the case to the ED for further prosecution.

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T 945/09 – The Patient Who Knew

The opponent filed an appeal against the decision of the Opposition Division (OD) to reject the opposition.

Claim 1 as granted read:

Use of taurolidine or taurultam in the manufacture of a solution for preventing or reducing infection and sepsis in or caused by a delivery system for administration of a desired liquid material to a patient or withdrawal of a blood sample from a patient, wherein said solution is employed to fill the system between each said administration or withdrawal so as to act as an antimicrobial seal serving to prevent or reduce said infection and sepsis.

Document D3, on which a novelty attack was based, is an article published in the Journal of Parenteral and Enteral Nutrition in 1998, i.e. after the earliest priority date of the patent under consideration (December 23, 1996). This article reported on a previous use of 2% taurolidine solutions to fill catheters).

The OD considered that this use did not destroy the novelty of Claim 1 because it was covered by an implicit obligation of confidentiality. According to the OD, the evidence provided by the opponent was not sufficient to establish that there was no such obligation or that it had been violated.

The Board does not come to the same conclusion.

[3.1] In one of the alternative embodiments the claimed subject-matter of the patent in suit relates to

• the use of taurolidine in the manufacture of a solution
• for preventing infection and sepsis
• in a delivery system for administration of a desired liquid material to a patient,
• wherein said solution is employed to fill the system between each said administration
• so as to act as an antimicrobial seal
• serving to prevent said infection and sepsis.

[3.2] Document D3 teaches

• the use of taurolidine in the manufacture of a solution […]
• for preventing infection and sepsis […]
• in a delivery system for administration of a desired liquid material to a patient […],
• wherein said solution is employed to fill the system between each said administration […]
• serving to prevent said infection and sepsis […].

The person skilled in the art of total parenteral nutrition at the priority date of the patent in suit knows that the catheter lumen must be sealed during times when it is not used for administration of the nutrient, and refers to it as the lock-technique. This seal may be performed using heparin solution as is referred to in document […].

Thus, the remaining feature

• so as to act as an antimicrobial seal

is also inevitably comprised in the teaching of document D3.

Consequently, the teaching of document D3 in the form of the reported use of taurolidine solution as a lock represents all the features of claim 1 of the patent in suit.

[3.3] Concerning the question of when this teaching of taurolidine-lock was performed, and in particular when it began to be performed, there is prima facie the clear-cut normal case that a paper is ready before it is sent to a journal for publication and there is normally no need for substantial amendments after the date of receipt. First there is the record of a success, then the idea and realisation of publication follow. In the current case there is evidence for the particular date of receipt at the bottom of page 242 of document D3, left column: “Received for publication, May 28, 1997”.

Since any decision to publish a paper inevitably must lie in the period before its receipt for publication, the authors of document D3 must have decided to publish their experience in the time before May 1997. Following the time frame proposed by the respondent, this would have been just shortly after they had removed the catheter and implemented systemic antibiotic treatment (ten months after March 1996, which was January 1997) - stripped of the experience of a further 12 months free of infection.

According to these considerations, the board is satisfied that the starting date for the use of the taurolidine-lock can be set at 22 months before the date of receipt for publication, i.e. July 1995.

Doubting this normal sequence of actions, under the circumstances of the current case as set out, requires tangible evidence and not just one example of differing experience in another case and statements based on several mere assumptions […]. The maxim “reus in excipiendo fit actor” applies here. The burden is on the respondent to show that the actual facts and their sequence in truth were different.

[3.4] In document D3 it is pointed out that

“Ten months before the last infection, the patient was instructed to instil 1.5 mL taurolidine 2% daily into his central line after finishing his HPN (home parenteral nutrition) infusion and has continued to do so 2 years to date” (parenthesis inserted by the board).

Thus, the teaching according to claim 1 of the patent in suit was used by a patient while having “home parenteral nutrition” (HPN). Such a patient, aged around 30, after his long history of complications leading to multiple replacements of the catheter […] usually knows what is happening to him and he is interested in the nature of all actions intended to bring him relief. In addition, the “evaluation of the patient’s protocol of site care” mentioned in document D3 […] would not have been possible without exact explanation for instance of the purpose of the daily instillation of 1.5 mL of heparin solution. Consequently, it is also to be seen as a prerequisite that the intention connected with the heparin replacement by 1.5 mL of taurolidine solution […] was sufficiently explained to him.

In addition, there is no remark in document D3 indicating anything to the contrary.

Therefore, the board has to base its considerations and conclusions on the knowledge of the patient being clear and concise enough that he could take notice of the technique used after replacement of heparin-lock by taurolidine-lock, representing the teaching of claim 1 of the patent in suit.

There was also no reason for him to treat this knowledge as a secret, because at that time the acting doctors simply tried to apply taurolidine of whatever provenance using a technique they derived freely and easily from the state of the art common to them at that time […]. Obviously, they never saw anything special about that treatment, and consequently there is no indication of confidentiality in document D3.

[3.5] Accordingly, the board concludes that this teaching was performed beginning from July 1995 in the full knowledge of the patient without any obligation of confidentiality and thus was publicly available before the priority date of the patent in suit.

[4] In these circumstances the arguments of the respondent cannot lead to success.

[4.1] To the extent that the respondent calls for standards for a chain of evidence and arguments on the basis of the balance of probability, the board sees the argumentation of the appellant as being based on an indicative document, whereas the respondent itself tries to establish a chain of evidence and arguments to cast doubt on a document which prima facie appears to be decisive. Thus, the required standards have a priori to be applied to the arguments of the respondent.

[4.2] The respondent concludes from the age 29 mentioned at the beginning of document D3 and the following series of episodes of catheter-related bloodstream infections (CRBSIs) and line changes that the letter of authorisation dated 12 March 1996 (document D20b) is related to the same patient mentioned in this letter as “HP” at the age of 30. Since, as reported in documents (12) and (20a), it was the first shipment of taurolidine from the respondent to the Canadian team after a long break, the respondent draws the further conclusion that there were no reserves from the last shipment, and the beginning of the taurolidine treatment of the patient reported in D3 thus could not have started before this shipment of March 1996. Disclosure of document D3 was consistent with this view on the basis of a simple update before printing.

But this chain of various indicia, put together from different documents that are not all known in their full context, together with the attempt to establish the identity of the patient through indirect conclusions, is not well-founded enough to cast doubt on the straightforward starting date of taurolidine-lock treatment of catheter-related bloodstream infections derived from the disclosure of document D3. In particular, the mere statement that there was an amendment of the text of document D3 is not sufficient to make such an event a reality.

[4.3] The fact that the taurolidine-lock treatment at least at the beginning of the last twelve months (“New tunnelled subclavian” from table 1 of document D3) was accompanied by systemic therapy with vancomycin and was maybe in parallel at any time with taurolidine as an additive to the nutritional solution (Ninewell’s method) is irrelevant with respect to the clear intention of the Canadian team to interrupt the pattern of catheter-related bloodstream infections by use of the taurolidine-lock technique. The test was made using the taurolidine-lock and in full awareness of the problems of the patient with regard to repeated sepsis originating from the catheter and with the intention of fighting this problem by using this lock technique […]. Addition of systemic vancomycin occasionally during this episode merely underlines that the lock-technique per se was directed to fight the sepsis originating from the catheter and not systemic sepsis.

Finally, document D3 even reports the authors as being convinced of the success of their use of antimicrobial taurolidine-lock with respect to infection being catheter-related […].

[4.4] Since the respondent no longer maintains its argument that a real confidentiality agreement existed between itself as a supplier of taurolidine and the Canadian team as user, and since it merely affirms that confidentiality was inherent, only this inherency is to be assessed, in particular in relation to the decision of a technical board of appeal cited by the respondent (T 1057/92):

In the cited decision the acting doctor is held not to be an appropriate witness to state what information was public […].

“… In these circumstances, the Board cannot accept evidence that the person carrying out the trials believed that she was making the results available to the public already when carrying out the trials, and not only later when publishing her paper, as evidence that it was indeed made available to the public at the time of the trials. Just because Dr Hedner knew exactly what trials she was carrying out, she is not the appropriate witness to state what, if anything, was made available to the public as a result of the trials. She was not in the position of a member of the public, and thus could only make conjectures about what knowledge the public might have acquired. The Board thus does not take these trials in the hospital on human patients into account for the purpose of assessing novelty or inventive step.”

In the current case, however, it is sufficient that the patient was aware of the treatment he received, and public prior use does not depend on the doctor being a witness. In addition, in the cited decision novelty was discussed with regard to whether a trace of another compound was present or absent (see point [5] of the decision), while in the current case the straightforward use of a compound as such was crucial for assessment of novelty.

Moreover, the action in the Canadian hospital of using the taurolidine-lock was not typical of a clinical or even an experimental approach because it was dictated by the instant necessity to help a patient in a very desperate situation and thus had not been planned systematically as a scientific experiment.

[4.5] Thus, the subject-matter of the sole request does not meet the requirements of A 54.

To download the whole decision, click here.

The file wrapper can be found here.

NB: I owe the knowledge of this decision, which had escaped my scrutiny, to the 2011 FNDE meeting in Lyon.

T 1605/07 – No Selection

The patent proprietor filed an appeal against the decision of the Opposition Division to revoke the opposed patent.

Claim 1 of the main request before the Board read (in English translation):

1. Process for the anodic electro-dipcoating of conducting surfaces by dipping in an aqueous anodic electro-dipcoating bath and connecting up as the anode characterised in that an aqueous anodic electro-dipcoating bath is used that contains 1 to 15 wt. %, referred to the binder solids of the electro-dipcoating bath, of one or more phosphoric acid epoxy esters and/or phosphonic acid epoxy esters with an acid number of 10 to 40 that are obtained by reacting one or more monomeric, oligomeric or polymeric epoxy compound(s) with phosphoric acid or phosphonic acids or their esters or mixtures thereof in the presence of one or more alcohols, chosen from the group consisting of n-butanol, tert.-butanol, sec.-butanol, isopropanol, n-propanol, methanol, ethanol and/or hexanol.

The discussion of the novelty of this claim contains some interesting statements on numerical ranges.

*** Translation of the German original ***

[3.1] The [opponent] has contested the novelty of claim 1 in view of document D1.

Document D1 discloses anionic electro-dipcoating compositions containing phosphoric acid epoxy esters obtained by reacting of phosphoric acid with an epoxy resin […]. The reaction is carried out in an organic solvent that is miscible with water, such as acetone, butanol, isopropanol, and similar organic solvents. However, ether alcohols are preferably used […]. Example 1 of document D1 discloses the production of a phosphoric acid epoxy ester in the presence of 2-butoxy ethanol, example 5 a method for the anodic electro-dipcoating of steel panels as the anode, by using an aqueous anodic electro-dipcoating bath containing the phosphoric acid epoxy ester produced in example 1.

However, the feature of an acid number of 10 to 40 for the phosphoric acid epoxy ester is not disclosed in document D1.

[3.2] The [opponent] submitted that this feature corresponded to a specific selection from the general disclosure of document D1. As such it did not comply with the principles applied by the Boards of appeal in their established case law concerning the novelty of selection inventions. In particular, the selected domain of 10 to 40 was not sufficiently remote from the value of 41.5 mentioned in example 1 of document D1. Moreover, the value would further decrease or even go below the upper limit of 40 if example 1 was carried out with the alcohols isopropanol and butanol, which were suggested in document D1, because, as explained by the [patent proprietor], mixed esters were formed when using the claimed alcohols, to which butanol and isopropanol belonged as well. As a matter of fact, the formation of mixed esters with free hydroxyl groups of phosphoric acid would lead to lower acid numbers. Moreover, there was no evidence for any particular effect related to the selected range of 10 to 40 besides the influence on dispersibility known from document D1.

The [opponent] admitted that there was no disclosure of an acid range with exact limits, but he referred to column 4, lines 4 to 14 of D1.

In this passage, in the context of binder systems, acid numbers of 12 to 60 were mentioned as preferred values for electro-dipcoating deposition. Admittedly, this domain was disclosed for other compositions but they had acid groups serving the same purpose, i.e. making dispersion possible, very much like the phosphoric acid epoxy esters. Therefore, one might expect the same acid numbers for the phosphoric acid epoxy esters. Therefore, the range selected according to the invention was not a narrow sub-range either.

[3.3] The Board does not share the opinion of the [opponent].

As far as the acid number is concerned, document 1 does not disclose a range having a specific upper and lower limit such that the claimed range would constitute a selection. It only discloses one single value of 41.5 in example 1, which is clearly outside the claimed range. Apart from that, document D1 only contains a general statement that the presence of the phosphoric acid (group) leads to a measurable acidity which is or can be advantageous for dispersibility and subsequent curing […] Therefore, the present case does not correspond to the selection of a sub-range of numerical values from a greater range but to the choice of a specific feature, i.e. an acid number of 10 to 40, from a generic disclosure, i.e. a generally disclosed acidity. However, according to the established case law of the Boards of appeal a generic disclosure does not destroy the novelty of the specific disclosure.

The acid number range of 12 to 60 in column 4 of document D1 cited by the [patent proprietor] clearly refers to the preferred range of the specific copolymers mentioned therein. There is no indication for a combination of this range with the phosphoric acid epoxy esters. The notion of dispersibility mentioned for both the copolymers and for the phosphoric acid epoxy esters cannot be construed to be such an indication. Copolymers of monomers containing olefinic carboxyl groups and substances carrying hydroxyl groups on the one hand and phosphoric acid epoxy esters on the other hand are completely different classes of substances and, therefore, also have different properties, e.g. a different solvation and dispersion behaviour. The fact that according to document D1 both compound groups are dispersible in water, wherein a certain acidity is apparently advantageous, does not mean that the acid numbers necessarily have to be identical. Therefore, document D1 does not directly and unambiguously disclose a range of acid numbers of 12 to 60 for the phosphoric acid epoxy esters. When transferring the preferred acid number range for copolymers (12-60) to phosphoric acid epoxy esters, the [opponent] makes an a posteriori interpretation of document D1 based on the knowledge of the invention, in order to arrive at a method according to claim 1 of the main request.

Concerning the [opponent’s] assertion that when example 1 of document D1 is reworked using the alcohols explicitly mentioned in column 2 (isopropanol and butanol), the reaction product could result in an acid number below 40, it has to be noted that the [opponent], who bears the burden of proof, has not submitted any trials which could corroborate his assertion. He rather relies on assertions of the [patent proprietor], i.e. the alleged formation of mixed esters, but he simultaneously questions them as being unproven. There are no documents available to the Board which would clearly and unambiguously prove that reworking of example 1 with isopropanol or butanol leads to a reaction product having an acid number in the claimed range. Therefore, the assertion of the [opponent] is mere speculation.

To download the whole decision (in German), click here.

The file wrapper can be found here.

T 1245/09 – Ten Years After

The opponent filed an appeal after the Opposition Division (OD) had maintained the opposed patent in amended form.

In what follows the Board dealt with the admissibility of documents D7, D8, D17, D18, D30 related to a seminar held in 1990, which documents had been filed belatedly during the opposition proceedings. Document D30 was a compilation of documents D7, D17 and D18.

The patent proprietor pointed out that it was unknown whether these documents were distributed at the seminar or afterwards. Moreover, it was not known whether the seminar was public and whether the participants were bound by a confidentiality agreement.

[2.1] Documents D7, D8, D17, D18, D30 are written disclosures allegedly relating to presentations held in September 1990 at the Stratco 1990 Alkylation Seminar. In the oral proceedings before the Board the [patent proprietor] did not doubt that the documents of the Seminar were distributed to the participants of this seminar. The issue was rather, when this happened, whether the seminar was open to the public and whether the participants were bound to a confidentiality agreement.

[2.2] The introduction of document D30 was already refused by the OD given the late stage of the procedure at which the introduction of D30 was proposed. Additionally, the individual parts of this document, i.e. D7, D17 and D18 were already part of the procedure.

[2.3] The Board does not see any reasons for deviating from the OD’s view. Even more so, as each of the individual disclosures represents an individual lecture. The fact that they were held by the same lecturer does not necessarily mean that their contents have to be seen in context. On the contrary, in particular D17 appears to be an independent lecture given the structuring and the index of the individual chapters as shown on page 2.

Thus, the Board does not introduce D30 into the appeal procedure.

[2.4] With regard to the individual documents D7, D8, D17, D18 no proof has been submitted by the [patent proprietor] supporting the allegation that the seminar was not open to the public or that the participants were bound by a confidentiality agreement. It was not denied by the [patent proprietor] that the seminar’s participants received the printout of the written submissions. The only question to be clarified is, whether this happened at the seminar or some time, i.e. a couple of weeks or months later.

However, this question is of no relevance for the present appeal, as the seminar took place in September 1990, whereas the priority date of the patent-in-suit is March 2000. Given the length of this period, the skilled person was certainly able to obtain the documents well before the present priority date.

[2.5] Given the fact that a confidentiality agreement or restrictions in the participation of the seminar have not been proven and that the priority date of the patent-in-suit is almost ten years after the seminar, documents D7, D8, D17, D18 are considered to have been publicly available at the priority date of the patent-in-suit and to represent state of the art according to A 54(2) EPC (1973).

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The file wrapper can be found here.

A French summary has been made available to the public by Laurent Teyssèdre (here).

T 1523/08 – Not Fresh

In this case claim 1 of the patent as granted was attacked on the grounds of lack of novelty and of inventive step; dependent claim 4 only for lack of inventive step.

In response to the preliminary opinion expressed by the Opposition Division (OD) the patent proprietor filed a new main request, claim 1 of which was a combination of claims 1 and 4 as granted.

The opponent attacked this claim for lack of novelty.

The patent proprietor requested the novelty attack not to be admitted as, in the notice of opposition, claim 4 was only attacked for lack of inventive step. The ground of lack of novelty, therefore, was a new ground of opposition.

The OD dismissed this request because it could not “detect a new ground for opposition in the contesting of the novelty of claim 1 as the notice of opposition indicated the patent to be attacked in its entirety on lack of novelty as well as inventive step.

The OD finally maintained the opposed patent on the basis of the third auxiliary request.

The patent proprietor filed an appeal.

The main request before the Board was identical to the main request before the OD.

The patent proprietor reiterated his argument against the novelty attack.

Here is what the Board had to say:

[2.1] Novelty as a fresh ground for opposition It is a fact that claim 4 as granted, which has been combined with claim 1 as granted to form claim 1 of the main request, was only objected for lack of inventive step in the notice of opposition.

However, lack of novelty as a ground for opposition was raised in the notice of opposition and substantiated e.g. with respect to claim 1. Hence, lack of novelty as a ground for opposition cannot be regarded as a fresh ground for opposition.

This is in line with G 10/91 [15-16], in which it is stressed that the grounds for opposition are linked to the “statement pursuant to R 55(c) EPC 1973”, with R 55(c) EPC 1973 requiring the opponent to present an indication of the facts and evidence in support of the grounds for opposition.

This means that a ground for opposition raised must be substantiated with facts and evidence, but it cannot be inferred that a ground for opposition raised and substantiated in the notice of opposition with respect to an independent claim - in the present case, claim 1 - but not with respect to a dependent claim - in the present case, claim 4 - will amount to the introduction of a fresh ground for opposition when substantiated for the combination of the independent and the dependent claim - in the present case, the combination of claims 1 and 4 - only later in the proceedings.

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T 1069/08 – Late Argument

In this case the opponent filed an appeal after his opposition had been rejected by the Opposition Division (OD).

The relevant claims of the patent were directed at a purified or isolated polypeptide capable of desaturating a fatty acid molecule from the carboxyl end of the fatty acid.

In his statement of grounds of appeal, the opponent contested the findings of the OD concerning A 100(b) and A 100(a) as regards inventive step. According to him, claim 1 encompassed polypeptides that did not possess the activity of desaturation and, therefore, did not solve the technical problem.

The Board found that the ground for opposition under A 100(b) did not prejudice the maintenance of the patent as granted. Moreover, it pointed out that the claims on file contained a functional feature limiting it to polypeptides that were capable of desaturating, which made the opponent’s argument irrelevant.

During oral proceedings (OPs) before the Board, held in the absence of the patent proprietors, the opponent argued that the solution to the problem was obvious.

The Board refused to discuss this issue:

[23] The findings of the examining division in examination proceedings regarding the non-obviousness of the claimed subject-matter were not contested in the opponent’s notice of opposition, nor did the OD consider that there was any reason to examine them of its own motion. Accordingly, the decision under appeal is silent on this issue. This issue was not raised in the appellant’s grounds of appeal which, as regards A 56, contested, only and exclusively, the broad scope of the claims.

[24] Indeed, it was only in the board’s communication pursuant to Article 15(1) RPBA that the board, when discussing the issues under A 56, drew the attention of the parties to the examination proceedings and noted that “none of the parties in the present appeal proceedings has explicitly referred to these specific arguments … or to the particular documents introduced into the examination proceedings to support them”. The board further pointed out the relationship between sufficiency of disclosure and inventive step and to the fact that the “same criteria” had to be applied for assessing both the disclosure content of the patent-in-suit and that of the prior art documents.

[25] In reply to this communication, the [patent proprietors] vehemently protested against a revision of the examination proceedings. With reference to decision G 9/91, they stated that

“none of those facts, evidence and arguments have been put into the present proceedings, since they were, and are, irrelevant to the parameters of the opposition established by the parties to this opposition”.

[26] In its reply, the appellant argued that “making an argument of lack of inventive step of the claims based on the teaching of D1 is not a new ground, and this does not contravene the procedural requirements of the EPC” because document “D1 has since the beginning of these proceedings always been considered as the closest prior art by the opponent”.

[27] Apart from this statement of the appellant, no other submissions were made in appeal and in opposition proceedings on the obviousness – or lack thereof – of the claimed subject-matter. It was only at the OPs that the appellant requested the board to have the opportunity to present its arguments on this issue.

[28] This request was not allowed by the board for the following reasons:

[28.1] According to Article 12(2) RPBA, the statement of grounds of appeal shall contain a party’s complete case and specify expressly all the facts, arguments and evidence relied on. Article 13(1) RPBA states that any amendment to a party’s case after it has filed its grounds of appeal may be admitted and considered at the board’s discretion.

In the present case, the appellant’s statement of grounds of appeal did not include any argument regarding the obviousness of the claimed subject-matter. Hence, the introduction of this new argument at OPs would represent an amendment to the appellant’s case. It is thus at the board’s discretion to admit and consider it.

[28.2] Article 13(1) RPBA states that this discretion shall be exercised in view of, inter alia, the complexity of the new subject-matter submitted, the current state of the proceedings and the need for procedural economy.

In the present case, the appellant failed to submit the new argument at an early stage of the appeal proceedings. Even after the board’s communication in which reference was made to the examination proceedings and to the relationship between sufficiency of disclosure and inventive step (cf. point [24] supra), the appellant did not consider it necessary to introduce the new argument into the appeal proceedings but only referred, in very general terms, to its right to raise an objection for lack of inventive step based on document D1 (cf. point [26] supra). OPs in appeal are usually, if not always, the latest stage of appeal proceedings and thus, facts, arguments and evidence submitted at that stage are usually considered to be late.

[28.3] The appellant argued that the new argument at OPs was a direct reaction to the board’s reasoning when arriving at its opinion on A 100(b) in the OPs. No other reasons were provided to justify the introduction of this argument at such a late stage of the appeal proceedings.

In the light of the content of the board’s communication pursuant to Article 15(1) RPBA, the board’s reasoning when arriving at its opinion on A 100(b) in the OPs cannot be considered to have come as a surprise to the appellant. It was in this communication that the board addressed the relationship between sufficiency of disclosure and inventive step and pointed to the use of the “same criteria” for both articles (cf. point [24] supra). The appellant could, and indeed should, have considered that the board could reach the same conclusion as the OD as regards A 100(b) and, if it wished the board to consider a new argument to establish inventive step based on the use of the “same criteria” in both A 83 and A 56 and/or on the obviousness of the claimed subject-matter, it should have set out this argument, at the very latest, in its reply to the communication of the board.

[28.4] This was all the more so in view of the [patent proprietors’] protest in their reply to the board’s communication, in which they also announced their intention not to attend the OPs […]. It was in the appellant’s interest to submit all new facts, arguments and evidence as soon as possible, and certainly before the OPs, so as to avoid the possible risk of taking aback the [patent proprietors] and/or the board, and thereby compelling the board to adjourn the OPs or to disregard these new facts, arguments and/or evidence.

[28.5] Indeed, the appellant’s failure to submit the new argument in reply to the board’s communication deprived the [patent proprietors] of the opportunity to present their comments thereon and/or of the opportunity to reconsider their intention not to attend the OPs. The introduction of this new argument at OPs – in the absence of the [patent proprietors] – could well raise the question whether the board could arrive at a decision without violating the [patent proprietors’] right to be heard (A 113(1)) or, in order to avoid it, to adjourn the OPs.

[28.6] In this regard, Article 13(3) RPBA states that amendments sought to be made after OPs have been arranged shall not be admitted if they raise issues which the board or the other party cannot reasonably be expected to deal with without adjournment of the OPs. This is in line with the need for procedural economy referred to in Article 13(1) RPBA for the board to exercise its discretion (cf. point [28.2] supra).

In view of the submissions made by the parties during the written phase of the appeal proceedings, the board was convinced that the introduction at OPs of the appellant’s new argument - with or without reference to all the evidence submitted at the examination proceedings - certainly went against the need for procedural economy and it could well require the adjournment of OPs.

[28.7] Thus, the board in the exercise of its discretion did not admit the appellant’s request to have an opportunity to present its arguments on the obviousness of the claimed subject-matter at the OPs.

[29] Having considered the arguments put forward by the appellant, the board is not persuaded that the subject-matter of the claims as granted lacks inventive step within the meaning of A 56. Thus, the ground for opposition under A 100(a) does not prejudice the maintenance of the patent as granted. […]

The appeal is dismissed.

To download the whole decision, click here.

The file wrapper can be found here.

NB : A good French summary is available on Le blog du droit européen des brevets.

T 1508/08 – Correctional Facilities

As we have seen in an earlier post, drafters of applications dealing with monomers and polymers have to be careful because it is easy to mix up these terms … and difficult to correct the resulting errors.

The present appeal was filed after the Opposition Division (OD) had revoked the opposed patent. The decision in itself is not very surprising but it reminds us of the rules that govern corrections.

Claims 1, 7 and 9 of the patent as filed read (in English translation):

1. A process for the production of conducting wires coated with cross-linked polyethylene, in which process a granulate made of polyethylene is coated with a fluid cross-linking agent, the coated granulate is melted in an extruder and extruded onto the electrical conducting wire, and the extruded layer is cross-linked by heating to a temperature above the decomposition temperature of the cross-linking agent, characterized in that a mixture of granulate, meal, or powder made of a polyethylene homopolymer and a polyethylene copolymer is coated together with the cross-linking agent and stabilizer, wherein the portion of copolymer in the coating on the cable is between 1 and 8% by weight.

7. A process according to claim 1 to 6, characterized in that a polyethylene copolymer having a portion of copolymer of over 16% is used.

9. A process according to any one of claims 1 to 8, characterized in that ethylene vinyl acetate (EVA), ethylene butyl acrylate (EBA), ethylene ethyl acrylate (EEA), and/or ethylene methyl acrylate (EMA), with a portion of copolymer being from 10 to 30% by weight, is used as polyethylene copolymer. (my emphasis)

Claim 1 of the main request before the Board read (in English translation):

1. A process for the production of a cable consisting in conducting wire coated with cross-linked polyethylene, in which process a granulate made of polyethylene is coated with a fluid cross-linking agent, the coated granulate is melted in an extruder and extruded onto the electrical conducting wire, and the extruded layer is cross-linked by heating to a temperature above the decomposition temperature of the cross-linking agent, characterized in that a granulate, meal, or powder made of a polyethylene homopolymer and a polyethylene copolymer is mixed together in a tumbler mixer at an elevated temperature, which temperature is below the melting point of the polyethylene homopolymer and/or polyethylene copolymer and is simultaneously coated with a fluid mixture of cross-linking agent and stabilizer, wherein the polyethylene copolymer is chosen from among ethylene vinyl acetate (EVA), ethylene butyl acrylate (EBA), ethylene ethyl acrylate (EEA), and/or ethylene methyl acrylate (EMA), with a portion of comonomer from 10 to 30% by weight, and wherein the portion of comonomer in the coating on the cable is between 1 and 8% by weight. (my emphasis)

*** Translation of the German original ***

[3.1] The parties did not agree on whether the comonomer portion mentioned in claims 1 to 4 and 7 of the main request complied with the requirements of A 123(2).

The passages of claims 1 to 4 and 7 of the main request read (emphasis by the Board):

• “wherein the portion of comonomer in the coating on the cable is between 1 and 8% by weight” (claims 1 to 4)
• “wherein the polyethylene copolymer is chosen from among ethylene vinyl acetate (EVA), ethylene butyl acrylate (EBA), ethylene ethyl acrylate (EEA), and/or ethylene methyl acrylate (EMA), with a portion of comonomer from 10 to 30% by weight” (claims 1 to 4)
• “a polyethylene copolymer having a portion of comonomer of above 16% by weight” (claim 7).

[3.2] These passages are derived from the following passages of original claims 1, 7 and 9 (emphasis by the Board):

• “wherein the portion of copolymer in the coating on the cable is between 1 and 8% by weight” (original claim 1)
• “wherein ethylene vinyl acetate (EVA), ethylene butyl acrylate (EBA), ethylene ethyl acrylate (EEA), and/or ethylene methyl acrylate (EMA), with a portion of copolymer from 10 to 30% by weight are used as polyethylene copolymer” (original claim 9)
• “a polyethylene copolymer having a portion of copolymer of above 16% by weight” (original claim 7).

The passages of the original claims 1, 7, and 9 do not disclose a portion of comonomer but exclusively refer to a portion of copolymer (see emphasis by the Board).

Also, the rest of the application as originally filed exclusively refers to portions of copolymers, wherein the following is disclosed:

• “The essential advantage of the invention can be seen in that by the use of a mixture of polyethylene homopolymer and polyethylene copolymer with a limited amount of copolymer, the resistance of the cable insulation to the formation of water trees can be significantly increased.” (last paragraph of page 2)
• Coating of a wire with a mixture of 20 parts of polyethylene copolymer, 80 parts of LDPE (polyethylene homopolymer), 2 parts of dicumyl peroxide and 0.2 parts of stabilizer, corresponding to a portion of polyethylene copolymer of 19.6%, based on the mix used for coating (Examples 1 and 2).
• Coating of a wire with a mixture of 20 parts of polyethylene copolymer, 80 parts of LDPE (polyethylene homopolymer) and an undefined quantity of highly concentrated peroxide/stabilizer batch based on polymers (Example 3).

The application as originally filed, therefore, does not directly disclose the comonomer portions claimed in claims 1 to 4 and 7 of the main request.

[3.3] According to the [patent proprietor], the comonomer portions of claims 1 to 4 and 7 are obtained when the expression “portion of copolymer” in claims 1, 7, and 9 as originally filed is corrected to read “portion of comonomer”. This correction was allowable pursuant to R 139.

As mentioned in G 3/89 [2] the requirements for allowing a correction consist in that

(a) the incorrect information is objectively recognisable as such for the skilled person, and

(b) the correction that is carried out must correspond to the only possible correction which the skilled person would consider on the basis of the original disclosure of the opposed patent and his common general knowledge.

[3.4] As far as the first requirement is concerned, the Board agrees with the [patent proprietor] that the indications regarding the copolymer portions are contradictory in the application as filed. For instance, there is a contradiction between the portion of copolymer between 1 and 8% by weight in the coating according to original claim 1 and the portion of polyethylene copolymer of 19.6%, based on the mix used for coating in Examples 1 and 2. Moreover, there is a discrepancy between the portion of copolymer between 1 and 8% by weight in the coating mentioned in original claim 1 and the portions of copolymer above 16% from 10 to 30% by weight disclosed in claims 7 and 9. Finally, claims 7 and 9 of the application as originally filed are contradictory to each other because claim 7 requires a portion of copolymer of above 16% by weight whereas claim 9, which is dependent on claim 7, also appears to allow portions of copolymer that are below 16%.

Also, the wording of claims 7 and 9 of the application as originally filed “polyethylene copolymer having a portion of copolymer …” is objectively incorrect because a copolymer does not contain a portion of copolymer.

Therefore, the Board agrees with the [patent proprietor] that based on the whole disclosure of the originally filed application, it is obvious for the skilled person that the portions of copolymer mentioned in original claims 1, 7 and 9 are defective. Thus the first requirement for allowing a correction pursuant to A 139, as expressed in G 3/89, is fulfilled.

[3.5] On closer inspection, in order for the second requirement (b) mentioned in G 3/89 to be fulfilled, two things are required, i.e. that the skilled person, on the basis of the original disclosure of the opposed patent and taking into account his common general knowledge,

• would consider the correction that has been carried out, and, if so,
• would consider it to be the sole conceivable (in Frage kommend) correction.

[3.5.1] The Board will first examine whether the skilled person would consider the correction of the expression “portion of copolymer” to “portion of comonomer” […].

According to the [patent proprietor] it is clear for the skilled person that the desired effect of increasing the resistance to the formation of water trees [mentioned] on the last paragraph of page 2 of the originally filed application, can be obtained by limiting the portion of comonomer but not by limiting the portion of copolymer, as stated in this paragraph.

If this view was to be adopted, then one would expect the relevant portion of comonomer that is needed to obtain the desired effect to be given in the examples of the application – in the form of the erroneously used expression “portion of copolymer”. However, this is not the case. Quite to the contrary, the examples only contain indications regarding the content of copolymer (“20 parts of polyethylene copolymer” in Example 1 and “20 parts of PE copolymer” in Example 3) but do not make any statement of the comonomer contained therein, let alone its portion.

Thus, based on the original disclosure, and contrary to the arguments of the [patent proprietor], one has to assume that it is the portion of copolymer, and precisely not the portion of comonomer, that is relevant for obtaining the effect the application aims at. For this reason alone the skilled persons would not take into account the correction carried out by the [patent proprietor].

Moreover, this correction […] does not resolve the lack of clarity regarding the portions of copolymer in the application as originally filed in a technically meaningful way, as claimed by the [patent proprietor] […]. The correction of claim 7 leads to a portion of comonomer of above 16%, whereas corrected claim 9, which depends on claim 7, allows for portions of comonomer below 16%. Moreover, it is not clear whether the comonomers contained in LLDPE and VLLDPE are deemed to contribute to the portion of comonomers or if they may not be taken into account, because, according to original claim 8, LLDPE and VLLDPE are homopolymers, i.e. free from comonomers. Finally, it is not clear whether the polyethylene copolymers used in the examples have a portion of comonomer according to the claim and whether, therefore, the examples are consistent with the claims as corrected. Therefore, in this context, the Board cannot share the opinion of the [patent proprietor] according to which the portion of comonomer of the polyethylene copolymer in the examples is between 10 and 30% by weight, as indicated in original claim 9, because original claim 9 is a dependent claim and the portion of copolymer mentioned therein is not to be considered as an essential feature, i.e. a feature that is necessarily present in the examples.

Therefore, notwithstanding the correction, not only are there unresolved unclear issues, but there are even new ones added. For this reason also the skilled person would not consider the correction that has been made by the [patent proprietor].

[3.5.2] But even if one assumes, in favour of the [patent proprietor] that the skilled person would have considered the correction made by the [patent proprietor], this correction would not be the only possible correction.

For instance, the skilled person could keep the portion of copolymer of between 1 and 8% by weight mentioned in claim 1 and only correct the portions of copolymer mentioned in claims 7 and 9. Such a correction would indeed resolve the lack of compatibility between the portion of copolymer in claim 1 on the one hand and the one of claims 7 and 9 on the other hand and eliminate the objectively incorrect wording “polyethylene copolymer having a portion of copolymer …” in those claims.

As an alternative, the skilled person could keep all the portions of copolymer in the application and only insert the expression “…, based on the polymer mix” after the indication of the portions of copolymers. This would at least eliminate the objective incorrectness in claims 7 and 9 because then the portion of copolymer mentioned in those claims is not a portion of copolymer of the copolymer but of the polymer mix. Moreover, this would eliminate the contradiction between original claims 7 and 9 on the one hand and the examples on the other hand because then the portions of copolymer of the examples would then be encompassed by the ranges required in claims 7 and 9. Finally, the claims amended accordingly would be consistent with the last paragraph of page 2 of the description, which deals with the essential character of the portion of copolymer.

[3.5.3] Summing up, it can be said that the correction carried out by the [patent proprietor] would not be considered by the skilled person for the original claims 1, 7, and 9 and, if at all, would only be one of at least three conceivable corrections.

Thus the second requirement (b) for allowing a correction pursuant to R 139 is not fulfilled.

[3.6] The amendment of the expression “portion of copolymer” to “portion of comonomer” in the claims of the main request is not based on a correction that can be allowed pursuant to R 139. Therefore, this correction violates the requirements of A 123(2).

During the oral proceedings before the Board, the patent proprietor also filed auxiliary requests wherein the correction was retracted. The Board considered these requests, which had been withdrawn beforehand, to be new requests and refused to admit them into the proceedings:

[4.3.4] Summing up, it can be said that the [patent proprietor], by filing the new auxiliary requests, not only contradicts all his prior submissions, but also revives objections which had long been overcome by the preceding requests, at the latest possible moment of the appeal proceedings. The Board is of the opinion that this way of proceeding comes very close to an abuse of proceedings and, irrespective of that, in any case, does not comply with the requirement of procedural economy.

The appeal was dismissed.

To download the whole decision (in German), click here.

The file wrapper can be found here.

T 7/07 – Fatal Yasmin

The opponent filed an appeal after the Opposition Division had rejected the opposition.

There were several third party observations (A 115) pointing out that the claimed subject-matter had been made publicly available through clinical trials of the oral contraceptive Yasmin® carried out between 1996 and 1998.

There also was an intervention (A 105) following the institution of infringement proceedings in Lithuania. Unsurprisingly, this intervention was found not to be admissible.

In what follows, the Board discusses the question of whether the clinical trials are novelty-destroying for the claims under consideration:

[3.1] In April 2008 a third party, Stragen Pharma, submitted a copy of a judgement by the United States District Court for the District of New Jersey dated 3 March 2008 […]. The judgement concerns the validity of US Patent No. 6 787 531, that corresponds to the patent in suit in the present appeal. The third party claims inter alia that claims 1-5 and 16-19 lack novelty over a prior use reflected in the US decision, namely the conduct of clinical trials with contraceptives containing the composition claimed in the patent in suit in the present appeal. These trials took place in the US between December 1996 and July 1998, i.e. before the priority date of the contested patent (31 August 1999). The participants were informed of the ingredients but had not signed a confidentiality agreement, and not all unused drugs had been returned. The third party claimed that as a result the drugs had become publicly available.

[3.2] During the oral proceedings the [opponent] argued for the first time that the trials mentioned in the US decision establish a novelty-destroying public prior use. Although these arguments were brought forward at a very late stage, they are nevertheless admitted by the board as the allegation of a novelty-destroying prior use does not amount to a new ground for opposition, was as a result of the third-party observations known since April 2008, and has prompted the [patent proprietor] to present counter-arguments in its written submissions.

[3.3] The [patent proprietor] did not contest that clinical trials were carried out prior to the priority date and that the principal investigators but not the participants entered into confidentiality agreements. The participants were informed about the active agents of the contraceptive, but were not told that the drospirenone was present in micronised form. Nor did the [patent proprietor] contest that the oral contraceptive used for the study comprised all the features of the subject-matter according to claim 1.

It is established board of appeal case law that if a single member of the public, who is not under an obligation to maintain secrecy, has the theoretical possibility to access particular information, this information is considered as being available to the public within the meaning of A 54(2).

The [patent proprietor] argued that the drug had not become publicly available before the priority date as according to established board of appeal case law any persons involved in clinical trials are (implicitly) bound to confidentiality.

The board does not agree with the [patent proprietor’s] interpretation of the case law. Both decisions cited by the [patent proprietor] (T 152/03 and T 906/01) concern prototype devices that were to be implanted in a small number of patients. Therefore, even if the patients did not sign a confidentiality agreement, they would not have been in a position to pass the prototypes on or even inspect them themselves.

Such trials are to be distinguished from trials where a large number of patients are given tablets to take home with them and for use over a longer period of time. It has been acknowledged by the US court that not all of the unused study drugs were returned. Therefore, it appears that after having handed out the drugs the [patent proprietor] effectively lost control over them as the participants in the clinical trials were in no way barred from disposing of the drugs as they wanted.

In view of these circumstances, the board comes to the conclusion that the handing out of the drugs to the participants made them became (sic) publicly available.

[3.4] The [patent proprietor] has also argued that the participants could not be bound by confidentiality as this would have been “unethical”. The US court had established that it would have been unethical to bind patients by confidentiality provisions as they should have been in a position to discuss the medication with their spouses and doctors.

The board has difficulties in reconciling this argument with the argument that there was an implicit secrecy agreement. Either there was an implicit secrecy agreement or there was not. The finding of the US court rather confirms that there was indeed no obligation of confidentiality.

Nor can the line of argument that it would have been unethical to have asked the participants to sign a secrecy agreement lead to a conclusion other than that the drugs had become publicly available before the priority date. If a product has become publicly available, it is irrelevant why it has so unless one of the exceptions in A 55(1) applies which is not the case here.

[3.5] A further argument brought forward by the [patent proprietor] is that the clinical trials were to be classified as “trade secrets” within the meaning of Article 39 TRIPS. While the TRIPS agreement is not binding on the EPO, it is an element that can be taken into consideration when interpreting provisions of the EPC which admit of different interpretations (G 2/02 and G 3/02). The [patent proprietor] has not stated which provision of the EPC is so ambiguous that an interpretation in the light of TRIPS would be appropriate.

Even if the TRIPS agreement were applicable, the purpose of its Article 39 is to clarify the obligation of WTO members under Article 10bis of the Paris Convention to provide for protection against unfair competition. Article 39, paragraph 2, TRIPS merely states that

“Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices…”.

This means that national authorities should allow natural and legal persons to keep particular information secret. In the present appeal the [patent proprietor] was in a position to keep information secret, but decided to distribute the product to selected members of the public before it had secured patent protection.

Under Article 39, paragraph 3, TRIPS, the authorities of WTO members are obliged to keep information submitted to them confidential. This provision too is of no relevance for the present case as the prior use does not concern the disclosure of information by a national authority.

[3.6] As the oral contraceptive used for the clinical trials was publicly available before the effective filing date of the contested patent and as the assertion that it comprises all the features of claim 1 of the main request was not contested by the [patent proprietor], it remains to be examined whether the skilled person was in a position to analyse its content and structure. In particular, it has to be evaluated whether he was able to determine the micronized state of drospirenone, which is an item of information that was not communicated to the women participating in the clinical trials.

According to G 1/92, the chemical composition of a product is state of the art when the product as such is available to the public and can be analysed and reproduced by the skilled person, irrespective of whether or not particular reasons can be identified for analysing the composition (see [headnote 1]). If it is possible for the skilled person to discover the composition or the internal structure of a product and to reproduce it without undue burden, then both the product and its composition or internal structure become state of the art (see point [1.4]). The Enlarged Board emphasises that there is no support in the EPC that the public should have particular reasons for analysing a product put on the market in order to identify its composition or internal structure (see point [2]).

This means for the present case that, in order for the oral contraceptive used in the clinical trials to be publicly available, the skilled person does not need any motivation for investigating the micronized structure of drospirenone. The only question is whether he is able to analyse the structure and composition of the product without undue burden. Regarding the composition of the prior use, the board notes that it belongs to the general knowledge of the skilled person to identify the active agents drospirenone and ethinylestradiol and to determine their concentrations within the tablet. This has not been contested by the [patent proprietor]. On the contrary, the [patent proprietor] has even acknowledged that this information had been passed on to the women participating in the clinical trials. Moreover, it does not require inventive skill to identify at least one excipient.

However, there was a long discussion at the oral proceedings as to whether it was possible to determine the micronized structure of drospirenone which had undergone a compression step during tablet formation. The [patent proprietor] argued that in principle such an analysis was possible via Raman spectroscopy. However, a large number of samples were necessary in order to calibrate the system. As the number of unreturned samples of the clinical trials was not known, there was no guarantee that the skilled person would have sufficient material for analysing the particle size of drospirenone.

The board cannot agree with this argumentation. As was correctly pointed out by the [opponent], it is not necessary to take tablets from the clinical studies for calibrating the system. This can also be done by using a different material. Once the system is calibrated, a single tablet from the clinical studies should be sufficient for determining the particle size of drospirenone.

The [patent proprietor] further argued that the contraceptive used for the clinical trials comprised 21 hormone- containing tablets and 7 placebos. As a consequence, it was not certain that the unreturned samples contained any drospirenone at all. This argument is not convincing either, for the following reason: in view of the fact that the women participating in the clinical trials were not bound to secrecy, the public availability of the prior use was not restricted to the unreturned samples but included all the tablets handed out to them. As the tablets and placebos were not randomly administered but follow a well-defined distribution scheme (e.g. 21 hormone containing tablets followed by 7 placebos), the participants had to be able to identify the two types of tablets. The skilled person therefore had no problems in selecting the hormone-containing specimens for his analysis. As a consequence, it was possible for the skilled person to discover the composition or the internal structure of the product Yasmin® used in the clinical trials mentioned above and to reproduce it without undue burden.

The subject-matter of claim 1 of the main request therefore does not meet the requirements of A 54.

To download the whole decision, click here. The file wrapper can be found here.

NB: Le blog du droit européen des brevets provides a French summary (here).

T 781/08 – No Clues Needed

When parties to opposition and appeal proceedings find opinions in the reasons for the decision which they would have liked to comment upon, they sometimes feel tricked and get in a lather. So the Enlarged Board has made clear (for instance in R 15/10)  that the Boards do not have to indicate their opinion before taking a decision. This principle also holds true for first instance decisions, as the present case shows.

Here the Board dismissed the opponent’s appeal against the decision of the Opposition Division (OD) to reject the opposition. As a consequence, it also refused his request for reimbursement of the appeal fee. The request for remittal was also refused, for the following reasons:

[3.2] The board also considered the question of whether the alleged violation was a substantial procedural violation justifying the remittal of the case to the department of first instance pursuant to Article 11 RPBA.

The appellant argued that its right to be heard (A 113(1)) had been violated because the OD did not inform the parties of its evaluation of the patent proprietor’s arguments prior to issuing the decision, even though a request for a written statement had been made by the appellant (then opponent).

[3.3] The board sees no procedural violation in the mere fact that the OD did not inform the opponent of its evaluation of the patent proprietor’s arguments prior to its decision. As stated explicitly in T 774/97 [2], A 113 requires that a decision should only be made on grounds on which the parties have had an opportunity to comment. If this opportunity is given by the written submissions from the parties without a communication from the OD there is no obligation to issue such a communication, even if a party requests one.

In the present case the appellant has objected that it did not have an opportunity to elaborate on the reasons given in the notice of opposition because it had not had an opportunity to respond to the OD’s perception of the case. However, contrary to what the appellant has alleged, the board cannot see that it was taken by surprise by the reasoning on which the decision was based, which in essence accepts the patentee’s counterarguments.

It is the responsibility of each party to present its arguments and counterarguments, bearing in mind that the purpose of any communication from the OD is merely to facilitate, and if necessary, to streamline, the discussion of the case. The absence of a communication in these circumstances does not amount to a procedural violation.

[3.4] The appellant argued that in accordance with decision T 849/03, taken by this board in a different composition, the right to be heard is not only violated if the grounds of a decision are not transmitted to the opponent prior to the decision, but also if the opponent cannot, at the given point of time, expect such a decision. The appellant submitted that after having requested a preliminary opinion of the OD and after a delay of three years after the patentee had filed its observations on the opposition, the decision of the OD could only be described as surprising.

The board does not accept this argument. In case T 849/03, which was ex parte, the examining division issued a decision after informing the applicant that they intended to call oral proceedings (OPs) as a second and final action if after the applicant’s response they did not find the case allowable. However, instead of appointing OPs the application was refused. The board considered that this was a substantial procedural violation as the appellant could have expected the examining division to summon to OPs as announced.

In the present case, no OPs were requested by the opponent nor were they conditionally announced by the OD. The argument of the opponent with respect to a lack of inventive step in the subject-matter of claim 1 of the patent based on D1 and the common general knowledge, was answered in the patentee’s first response in particular as regards feature 7. The appellant thus had ample opportunity to submit further observations after having received the patentee’s response. The OD by basing its decision on the written submissions of the parties did not go beyond the factual and legal framework determined by these submissions. Therefore, the appellant cannot claim that the content of the decision of the OD was surprising.

[3.5] For these reasons, the decision of the OD complies with the requirements of A 113(1).

To download the whole decision, click here.

The file wrapper can be found here.

T 715/09 – Classy

The inventive step assessment carried out in this decision contains an interesting statement on patent classification.

The Opposition Division maintained the opposed patent in amended form. Claim 1 of the request found allowable read as follows :

A glow plug for diesel engines, comprising:

• a metal tubular body (12) provided with means (14) for fixing it to the cylinder head of an engine;
• a metal sheath (24) carried by a the tubular body (12) and driven with interference into a cavity (16) of the tubular body;
• a first electrical terminal (30) connected to a heating resistor (33) set inside the aforesaid sheath (24);
• a second electrical terminal (32) electrically connected to the sheath (24); and
• means for electrical insulation of the metal sheath (24) from the metal tubular body (12), wherein said sheath (24) comprises a layer (36) of insulating material applied on a portion (34) of the outer surface of said sheath (24),

characterized in that said layer (36) of insulating material is applied by means of plasma deposition.

The Board examined whether this claim involved an inventive step :

[4.2.4] The claimed glow plug differs from the embodiment shown in Figure 4 of E3 only that the coating of insulating material has been applied by plasma deposition.

Objective Problem

[4.3] E3 simply states that the insulation is formed by a ceramic coating and no indication is given as to how the coating is to be applied […]. The objective problem to be solved is therefore, as formulated by the [opponent], to select a suitable method for coating the metal sheath, bearing in mind that the coating lies between two parts that are held together by means of an interference fit.

Solution

[4.4.1] Plasma deposition is a generally well known technique for coating objects with a ceramic layer that is hard and wear resistant, but the question is whether it is obvious to use plasma deposition for applying the insulating coating as described in E3.

Documents E7, E8 and E9 all describe the manufacture of glow plugs in which a ceramic coating step carried out by plasma deposition.

[4.4.2] E7 discloses a glow plug having a metal sheath (17) and a tubular body (11) that corresponds to tubular body (12) of the disputed patent. The metal sheath (17) extends beyond tubular body (11), and in this region it is coated with two insulation layers (23 and 27); a heating element (24) is sandwiched between these layers. These insulation layers are applied by plasma deposition. Hence plasma deposition is known for coating the metal sheath, albeit not in the region between the metal sheath and the tubular body which, as pointed out by the [patent proprietor], is coated with glass.

[4.4.3] E8 also concerns a glow plug and describes coating the plug by plasma deposition with a protective layer to protect the plug from the corrosive environment. Use of such a coating to form an insulating layer between a metal tubular body and a sheath is not described.

[4.4.4] E9 describes the application of a coating (20) by plasma deposition to the surface of a glow plug (see last paragraph on page 5). The coating (20) is porous and is intended to reduce the effects of thermal gradients (see sentence bridging pages 4 and 5); it is applied on top of a dense, abrasive resistant, insulating coating (13); it is not said how the latter coating (13) is applied.

[4.4.5] The skilled person reading E3 is looking for a means for applying the insulating coating. None of the documents E7, E8 or E9 explicitly discloses plasma deposition of an insulating coating in the region between the tubular body and sheath of a glow plug, hence the opposition division concluded that the claimed subject-matter had an inventive step.

[4.4.6] In addition, the [patent proprietor] submits that the skilled person versed in the art of glow plugs would not, as part of his common knowledge, be aware of plasma deposition technology. Support for this submission is that glow plugs and surface treatment techniques are in two completely different classes according to the international patent classification scheme, namely F23Q7/00 and C23C respectively. The Board disagrees for the following reasons.

IPC classification alone is no reason for determining whether or not two pieces of prior art can be combined. The mere fact that two documents have the same classification is no reason for saying the combination of the teachings is obvious (see T 745/92 [1.4]). Likewise the mere fact that the technologies have been given different IPC classes does not necessarily mean that they cannot be combined.

[4.4.7] In the present case E7 to E9 indicate that it is well known to use plasma deposition in the manufacture of glow plugs. Faced with the problem of finding a suitable method for applying the insulation coating shown in Figure 4 of E3, the skilled person would first turn to known methods in the field of glow plug manufacture.

Aware that plasma deposition generally provides hard, wear resistant ceramic coatings, it does not require any inventive activity for the skilled person to select this technique for making the glow plug of Figure 4 of E3.

[4.5] Consequently, the glow plug of claim 1 lacks an inventive step.

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