Tuesday, 29 December 2015

J 0007/13 - Everything gets more expensive, including divisionals

You can't blame the applicant for trying, but of course the EPO charges the most recent fees for a divisional filing, not the fees that had to be paid at the filing date of the earlier application, as explained in detail by the Legal Board of Appeal in the current case. It is a matter of interpretation because the law lacks an explicit outline that a divisional might encounter higher filing and search fees. Although G 3/98 concerned Art 55 EPC, the Board in this case indicates that it should be viewed in a broader sense than only in relation to Art 55 EPC. Moreover, the filing fees serve the purpose of the filing requirements (submitted documents, etc.), not the substantive prior art issues that relate to the fictitious filing date from the earlier application (or even the priority filing).
Summary of Facts and Submissions
I. European patent application No. 11 004 301.5 was received at the EPO on 25 May 2011. It was filed as a divisional of European patent application No. 03 746 402.1 (the earlier/parent application), which had been filed on 3 April 2003.
II. Together with the application documents, the EPO received Form 1010 listing the fees to be debited in respect of the divisional application from the account of the applicant's representative. The amount of the search fee was given as 800 euro. An accompanying letter contained the explicit instruction that, if any of the amounts indicated in the form were wrong, the right amounts were to be debited from the account.
III. With a communication dated 20 July 2011 the applicant was informed that the correct amount of the search fee payable in the present case was 1105 euro, so that an additional 305 euro would be debited from the representative's account. It was further set a two-month time limit for filing reasoned objections to that finding.
IV. By fax dated 28 July 2011 the applicant did so, arguing that "since the filing date of the present application is 3 April 2003, the correct amount of the European search fee is 800 EURO" and requesting either a refund or an appealable decision.

Friday, 25 December 2015

T 1112/12: is the amendment one of the types of amendments of G3/14?

In G3/14 the Enlarged Board of Appeal explained that during opposition no clarity objection can be raised for a number of specific types of amendments - in particular, if the amendments only relate to combining granted claims (or combining a granted claim with a portion of granted claim) or deleting alternatives from the granted claims, no clarity objections can be raised for clarity problems that were already in the granted claims because clarity is not a ground of opposition. In this case there was an amendment made by the patent proprietor and according to the opponent the amended claim lacked clarity. The clarity issue raised by the opponent was similar to a clarity issue raised by the Opposition Division. The Board concluded that this clarity problem was already in the granted claims. According to the Board of Appeal the amendment could be interpreted as deleting an alternative from the granted claim and, as such, the clarity objection is not allowed into this appeal procedure.
The interesting thing in this case is that the two alternatives are not defined as alternatives in the claims. According to the Board, the wording of a specific feature of the granted claims is such that only two alternatives fall within the scope of protection of that specific feature. One of the alternatives is excluded from the scope of protection in the amended claims. Subsequently this Board concludes that this is "deleting an alternative from the granted claims as meant by the Enlarged Board of Appeal in G3/14". Now I wonder whether I may conclude that: "By adding a disclaimer to a claim that excludes one of the alternatives that falls within the scope of protection of the granted claims, one prevents that the Opponent may raise clarity objections to your amended claim."?
Of course the reality of this case is a little bit more complex: during the opposition proceedings a not-supported-by-the-original-disclosure-objection was also raised against the now excluded / disclaimed alternative. 

Tuesday, 22 December 2015

T 1410/14 - Recognizable to skilled person within short period

In this opposition appeal, the appellant argues a lack of novelty based on public prior use.

Namely, according to the appellant, a tram of Bombardier, which was tested in the city of Lodz, anticipates the claim, while its use, i.e., the testing, was publically accessible. In particular, the appellant argued that all relevant features were visible from a pedestrian bridge crossing the rails of a trajectory of the tramcar, with the trajectory being completed 13 times during testing. 

With respect to a particular claim feature, namely a console of a swivel bearing which is moveable perpendicular to the direction of the tram ("Schwenklagerung eine(r) Konsole (3) (...), die am Wagenkasten (1) in Fahrzeugquerrichtung (Q) verschiebbar gehalten ist"), the appellant argued that such movement would have occured since the rails beneath the bridge were in bad condition, which would result in the tramcars moving mutually with respect to each other, causing the console to move +/- 2 to 2.5cm in the claimed direction, which in turn would be visible from the bridge.

Complicating the matter is that the console would only have been visibile from above for a short time, due to its arrangement within the narrow space between two adjacent tramcars.

Merkmale eines nur für einen kurzen Zeitraum sichtbaren Gegenstands sind nur dann der Öffentlichkeit zugänglich geworden, wenn zweifelsfrei nachgewiesen ist, dass für den Fachmann in diesem kurzen Zeitraum die Merkmale eindeutig und unmittelbar zu erkennen waren (Gründe, 2.1-2.5).

[English translation, paraphrased: Features of an object having been visible only for a short period are only then considered to be publically accessible, when it can be proven without a doubt that these features were clearly and directly recognizable to the skilled person within this short period.]

Friday, 11 December 2015

T 2369/10 - Second medical use of products

Medical Instruments

The applicant found a new medical use for an existing product; namely treatment of substance addiction using a neurostimulator.
Normally a product is not made novel merely by identifying a new use for the product. Although, a use claim or a method claim may be possible, a purpose limitation for a product must imply technical differences in the product itself for it to be novel. 

However, if the new use is a medical one, the option of method and use claims are blocked by article 53(c) EPC, which forbids patenting of medical methods (see the articles for details). Fortunately for medical researchers, an exception is made to the general rule;  a new medical use for "any substance or composition" will provide novelty (articles 54(4), 54(5) EPC, G 5/83).

But what if someone invents a new medical use for a product which is not a substance or composition? The possibility of a method or use claim is blocked by article 53(c) EPC.  The lack of novel technical differences blocks the product claim. Although, article 54 does not explicitly allow the application to products which are not substance or composition, it is not forbidden either. 

The board declined the invitation though, and ruled that no novelty is obtained by a medical purpose limitation if the object is not a substance or composition. A request to  refer questions to the Enlarged board was denied. 

No Catchword or headnote is provided but reasons 8.1 give the following summary.

In the present case, the Board holds that, having regard to the wording of Article 54(4),(5) EPC, the ordinary meaning of this Article shall not be extended so as to include something which is not explicitly provided for.

Consequently the Board considers that there is no basis to contemplate that novelty may be conferred on products, other than substances and compositions, by virtue of the provisions of Article 54(4),(5) EPC.

Wednesday, 9 December 2015

T 2477/12 - Priority (yes); Priority application incorporated by reference (no)

The EPO does not like the 'herein incorporated by reference' statement in applications, which is once again made clear in this Board of Appeal decision in which an applicant filed a divisional application without a sequence listing and relied on the fact that the priority document did contain the specified sequences, and that the priority document was referred to in the specification of the divisional as 'herein incorporated by reference'. The Board states that "in view of the degenerate nature of the genetic code, a mere verbal reference to a nucleic acid sequence encoding canine pre-proBMP-7 cannot be regarded as an implicit disclosure of a particular nucleic acid sequence encoding said gene. As far as protein sequences are concerned, a mere verbal reference to an amino acid sequence of canine pre-proBMP-7 does not necessarily disclose a particular amino acid sequence, as more than one such sequence may be known."
The Board cites T 689/90 and T 1497/06 for particular conditions that need to be satisfied to allow the incorporation of subject matter from a cited document. If the applicant would have indicated particular sequences that were presented in the priority application, then the Board might have reached a different conclusion but here the applicant could only rely on a general reference to the priority document, and it did not make it unambiguously clear that the sequences relied on were the ones specifically described in the priority application.

Summary of Facts and Submissions
I. The appeal lies against the decision of the examining division posted on 4 July 2012, whereby European patent application No. 10150052.8 was refused because it did not comply with the requirements laid down in Articles 76(1) and 83 EPC.

Friday, 4 December 2015

T 886/10: A system for implementing an entirely new business model

The Examining division refused the patent application because "the distinguishing features per se relate to business considerations". The Appellant did not agree with the Examining Division and filed an appeal. Appellant argued that the system is based on non-obvious technical considerations. 
The decision of the Board of Appeal is relative short. Often decisions are short because the Appellant was not very active in appeal procedure. In this case the Appellant tried to safe his case with submitting some arguments and filing an auxiliary request. However, it seems that the original application did not contain enough technical information to get a claim with inventive features that are not excluded under Art. 52(2)(c) EPC.

Tuesday, 1 December 2015

T 379/10 - Scope of appeal after successful petition for review

Back before the Boards of Appeal after a successful petition for review (case R 16/13), the question arises what the subject and scope of the appeal should be: can new facts, evidences and arguments / lines of reasoning be introduced by one or all parties, or is the appeal limited to overcoming the substantial procedural violation that was the petition for review? The Board concluded the latter.

Sunday, 29 November 2015

G 1/14 Inadmissible referral (late appeal - deemed not filed or inadmissible)

In G 1/14 the Enlarged Board of Appeal (very exceptionally) decided that the referral was inadmissible.

The board in T 1553/13 (dealt with in G 1/14) and another board in T 2017/12 (dealt with in G 2/14) referred the question (summary): "Where a notice of appeal is filed and/or the appeal fee paid after expiry of the time limit of Article 108 EPC, first sentence, is this appeal inadmissible or deemed not to have been filed?"

The case G 2/14 was closed as a consequence of the case being deemed withdrawn caused by non-payment of a renewal fee.

In T 1553/13 the Board concluded that the notice of appeal was filed too late and the appeal fee was paid too late. The decision to refuse the patent application was handed over by the EPO to the postal service UPS on 25 April 2013. The shipment was received at the office of the representative on the next day 26 April 2013 by a person named "Weber" according to the "Tracking Information"of UPS. On 7 May 2013 the representative signed the acknowledgment of receipt (EPA Form 2936) and sent it back to the EPO via fax on 8 May 2013. The notice of appeal was filed on 8 July 2013 (Monday) and the appeal fee paid on the same day. The representative held that R.126(2) did not apply and that the time limit was triggered by the actual receipt. The Board held that R.126(1) and (2) did apply and that the appeal was filed after the 10 days of R.126(2). The Board referred then the issue of whether the appeal should be seen as ‘not filed’ or as ‘inadmissible’.

In the proceedings before the Enlarged Board, an ‘amicus curae’ letter pointed out that the notification of the decision underlying the appeal was not notified as prescribed in R.126(1) valid at that moment. UPS was not a post service and the tracking information was no advice of delivery. R.126(1) was amended entering into force at 1 April 2015 to allow the EPO to use UPS. As a consequence, notification took place at the moment the representative was aware (7 May). The appeal was filed in time (using the automatic extension of the weekend).

The Enlarged Board fully agrees. Thus, the referring Board of appeal erred and the appeal was correctly filed. As a consequence, the necessity for answering the referred question is gone [Art.112(1)(a) implies that a decision must be required].

The Enlarged wanted to emphasize the ‘necessity criterion’ and came up with the following headnotes:

1. Befasst eine Beschwerdekammer die Große Beschwerdekammer mit einer Vorlagefrage nach Artikel 112 (1) a) EPU, so obliegt es vorrangig der vorlegenden Beschwerdekammer, in der Vorlageentscheidung darzulegen, dass und warum sie eine Entscheidung der Großen Beschwerdekammer über die Vorlagefrage für erforderlich zur Entscheidung in dem vor ihr anhängigen Beschwerdeverfahren erachtet. Dies ergibt sich auch aus Artikel 22 (2) Satz 2 VOBK, wonach die vorlegende Beschwerdekammer in der Vorlageentscheidung den Zusammenhang der vorgelegten Fragen darzulegen hat.

2. In jedem Fall hat die Große Beschwerdekammer zu prüfen, ob eine Vorlage die Voraussetzungen von Artikel 112 (1) a) EPÜ (einschließlich des Erforderlichkeitskriteriums) erfüllt und damit zulässig ist.

3. Beruht die Vorlage auf einer offensichtlich falschen Anwendung einer Rechtsvorschrift, mit der Folge, dass bei richtiger Rechtsanwendung dieser Vorschrift eine Beantwortung der Vorlagefrage durch die Große Beschwerdekammer nicht mehr als erforderlich für die Entscheidung im Beschwerdeverfahren erscheint, ist sie allerdings als unzulässig zu werten.

Tuesday, 24 November 2015

T 978/15 - Intermediate generalization in a multipurpose fabric

This Examination appeal centers on an intermediate generalization. The main claim concerns a 'multipurpose fabric suitable for home textile, upholstery & apparel textile application'. The fabric had been further limited to have a "cover factor of 14"; this feature was taken from example 2 of the description.

In the statement of grounds the applicant admits that this is an intermediate generalization but also points out that intermediate generalization are nevertheless allowed under some conditions. Unfortunately, the board is not convinced that those conditions are met in the present case.

Reasons for the Decision

Friday, 20 November 2015

T 0893/13 - Reimbursement of earlier appeal fee

This appeal follows an earlier appeal against the decision of the examination division to refuse the patent application based on a.o. a lack of clarity. In the earlier appeal, the examining division rectified its decision under Article 109(1) EPC and continued examination, only to decide (again) that the application did not comply with a.o. Article 84 EPC.

In the first appeal, the appellant did not request reimbursement of the first appeal fee, nor did the examining division order such reimbursement of its own motion. However, after rectifi­ca­­tion, the appellant did request reimbursement of the first appeal fee. In the present appeal, the appellant now (again) requests that the fee for the first appeal be reimbursed.

Tuesday, 17 November 2015

T 0740/15 - Two substantial procedural violations in one case

It may seem awkward that an opponent wants to continue an opposition even though the opposed patent has lapsed for all designated contracting states during opposition. However, in this particular case, the proprietor did not explicitly surrender his rights in the designated contracting states. Hence, the opponent could not be 100% certain that the proprietor would not try to restore any rights in any of the states as soon as the opposition proceedings would have been terminated. As a result the opponent expressed the wish to continue with the opposition and requested oral proceedings before any decision was reached. Nevertheless, the opposition division terminated the proceedings. This, as the Board in this case clearly indicates, is a substantial procedural violation and is an 'infringement' of Art 116(1) EPC. One may wonder why the opposition division came to their decision although the right to oral proceedings (when requested) is so firmly established in the EPC and the case law of the Boards of Appeal. Even worse, their issued decision did not contain any reasoning, which is also in breach with Rule 111(2) EPC: decisions that are open to appeal should be reasoned. Two substantial procedural violations justifying reimbursement of the appeal fee, in one single case.
Summary of Facts and Submissions
I. The appeal by the Opponent lies from the decision of the Opposition Division dated 18 February 2015 to discontinue the opposition proceedings against European patent No. 2 067 820 (Form 2351).
II. An Opposition had been filed against the patent on 27 January 2012 on the grounds of lack of sufficiency, novelty and inventive step. Oral proceedings were requested as an auxiliary measure.
III. The proprietor responded with a letter dated 17 September 2012, requesting to maintain the patent in amended form according to a new main request or two auxiliary requests filed therewith.
IV. On 11 August 2014, a communication pursuant to Rule 84(1) EPC was sent by the opposition division stating that the opposed patent had been surrendered or lapsed with effect for all the designated contracting states. In the communication it was stated that "the opposition proceedings may be continued at the request of the opponent, provided that within two months from notification of this communication a request is so filed." The communication further advised that the opposition proceedings would be discontinued if no such request was filed in due time "and the state of the files give no grounds for the proceedings to be continued by the European Patent Office".
V. The opponent filed a response to the communication on 15 September 2014, in which it was requested that the opposition proceedings "be continued". It was also stated that "for the avoidance of doubt, the Opponent maintains its previous arguments against the Patent and its request for oral proceedings.".
VI. On 18 February 2015, the opposition division issued the decision to discontinue the opposition proceedings.

Friday, 13 November 2015

T 2068/14: a right to oral proceedings by video conferencing?

photo AT&T picturephone
AT&T picturephone
During the examination and during the appeal procedure, the appellant (applicant) requested oral proceedings held by video conferencing. The examining division refused oral proceeding by video conferencing. In the appeal procedure, the appellant argues that refusing the oral proceeding by video conferencing is a substantial procedural violation. Not long before the scheduled oral proceedings of the appeal procedure, the appellant requested a re-scheduling of the oral proceedings of the appeal procedure and requested oral proceedings to be held by video conferencing. Also, with respect to "does the applicant have the right to oral proceedings by video conferencing", the appellant requested a referral of three questions to the Enlarged Boards of Appeal. It seems that the appellant finds it unfair that applicants who have appointed a professional representative who is not located close to Munich or The Hague have to bear higher costs for attending the oral proceedings. This decision of the Board discusses whether (and why) one has (or has not) the right to oral proceedings by video conferencing.

Tuesday, 10 November 2015

R 2/15 - Withdrawal as chairman

The petition for review concerns an interlocutory decision, taken by Board of Appeal, rejecting the petitioner's objection of suspected partiality raised under Article 24(3) EPC against its chairman. The chairman also gave notice himself that he should not take part in the present case pursuant to Article 24(2) EPC.

Sunday, 8 November 2015

T 0895/13 Insufficient disclosure for a medicine

The Board, in an opposition appeal, examines the requirements for disclosure of a medicament. It confirms that the principle defined in T 609/02, for a Swiss type of claim, also apply to a further medical use claim defined under Art.54(5) EPC2000. Applying this principle, the Board concludes that the invention is insufficiently disclosed (Art.83 EPC).
In doing so, the Board also makes clear that the assessment of the technical effect provided by the claimed subject-matter was to be made in the context of the assessment of sufficiency of disclosure and not under inventive step as was done by the Opposition Division.

Tuesday, 3 November 2015

J 22/14 - Back and forth in the register

Can the legal division correct a transfer recorded in the register, if it later doubts the transfer was legal? In this unusual set of circumstances a transfer of a patent application is contested by the parties. We will refer to the parties as the appellant and the respondent.

Originally, a direct European patent application was filed in the name of the respondent.  About 5 years later, the same representative filed a request to transfer the application from the name of the respondent to that of the appellant. As proof of the transfer selected pages of an Assignment Agreement were filed. 

Just over a year later, a request is filed with the legal division to revert the transfer. It is argued that filing only selected pages of the agreement is not sufficient and that authorizations were both lacking and not substantiated. The request is accompanied with an injunction of a Kantonsgerichts in Zug that purportedly proved that the agreement was signed for the respondent by someone who was not authorized to do so.

The legal division reverts the transfer because there is no national (court) decision that the transfer was valid.  (Bis zum Nachweis einer entsprechenden nationalen Entscheidung is daher der Rechtsübergang nicht i.S.v. Regel 22 EPÜ hinreichend nachgewiesen.)

The appellant requests an appealable decision and subsequently appeals it. The board reverts the decision of the legal division, and reverts the reversion.

Similar decisions between the same parties were made for patent applications in J 16/14, J 21/14, J 20/14, J 17/14, and for patents in J 18/14, J 19/14.

Friday, 30 October 2015

T 2230/10 - Linguistic in nature

In this opposition appeal, the applicant appealed against the decision of the Examining Division refusing European patent application as contravening i.a. Articles 52(1) and 56 EPC.

In the appeal, the appellant requested that the decision under appeal be set aside and that a patent be granted on the basis of the claims of the main request (or on the basis of the auxiliary requests).

Claim 1 of the main request reads as follows:

"A method of enabling a user to query an electronic document base, the method comprising the steps of:
- allowing a user to enter query words;
- generating one or more additional keywords based on a profile of the user; and
- searching in an electronic document base for documents that match the combination of query words and additional keywords,
characterized by further comprising the steps of:
- generating a set of concept keywords based on the results of the search; and
- storing the set of concept keywords in a dynamic part of the profile of the user."

The main issue in this appeal is whether the characterizing portion is of technical nature and thus has a technical effect. In its preliminary opinion, the Board appeared to be skeptical.

Tuesday, 27 October 2015

T 0970/12 - Yet another grant of re-establishment of right

This is another example where the Board of Appeal granted re-establishment of rights. Under very extraordinary circumstances and a combination of the Christmas and New years holidays, a sudden death of a close relative of the representative and the presence in the office of a trainee that did not know the correct procedures, the date for filing the Notice of Appeal was missed. The Board did not make much fuss and granted the re-establishment of rights.

Summary of Facts and Submissions
I. The present appeal lies from a decision of the examining division refusing European patent application No. 09166600.8, published as EP 2111855, under Article 97(2) EPC. The application was filed as a divisional application of European patent application No. 07007272.3, published as EP 1847256 (parent application).

Friday, 23 October 2015

T 1171/13: the assistant forgot to fax the statement of grounds of appeal

The Appellant (opponent) filed a request for re-establishment of rights because the assistant of the appellant's representative forgot to fax the statement of grounds of appeal on time while the representative had his holidays. The respondent (patent proprietor) argued that the system of the representative lacks cross-checks and, thus, that the system is not sufficient for showing all due care. The deadline/reminder for submitting the statement of the grounds of appeal was deleted after the representative indicated in the system that he had completed his tasks. The Board is of the opinion that, based on case law, the existing of such cross-checks is not relevant when the error only concerns forgetting to submit the statement to the EPO on time while the statement was ready on time. It seems that the system of registering deadlines and generating reminders is necessary to remind the representative to perform his task on time. On the contrary, it seems not to be necessary to use such a system for reminding the assistant to perform her task on time when it concerns an isolated mistake in a normally well-functioning system and when the assistant is well-trained, experienced, thoroughly component and well-instructed how to handle the letter drafted by the representative. I think that, for example, the Dutch Patent Office will require in such a case that the assistant also uses the system of generating reminders for submitting the letter on time.

Tuesday, 20 October 2015

T 1020/15 - Four substantial procedural violations

In examination appeal after a refusal due to an alleged lack of novelty, lack of inventive step and lack of clarity, the decision to refuse was under scrutiny as, among others, not (sufficiently) reasoned. The Board of Appeal identified four substantial procedural violations: comments from the applicant not taken into account (r.1.2.3), not sufficiently substantiated / no reasons given (r.1.2.4; r.1.3; r.1.4), Guidelines not followed (r.1.2.3, r.1.2.6, r.1.3), and interlocutory revision not granted (r.1.11). Further, common general knowledge was not acknowledged (r.1.10.1) which had a major impact on the assessment of patentability. The decision also shows (again) that also "decisions according to the state of the file" need to be as well reasoned as other decisions.

Saturday, 17 October 2015

J 2/14 Stay of proceedings – Fighting about beer dispensers

In two related cases a third party had requested suspension of proceeding under Art.61(1) [after entitlement proceedings had been started in Belgium]. Three years later the Belgian proceedings had not progressed. The Legal Division refused applicant’s request for resumption of the proceedings, which was already requested at the start of the suspension. The Board of Appeal summarizes that proceedings may be resumed at any moment. In this case the Board concludes that the third party had lost interest in the Belgian court proceedings and decided to resume grant proceedings before the EPO.

Tuesday, 13 October 2015

T 2249/10 - Lack of sufficiency for combination of parameters

The  polyethylene composition in Claim 24 in this opposition appeal is defined by a combination of parameters. Claim 24 according to the main request reads (simplified and formatted)

An injection moulded pipe fitting comprising a polyethylene composition (...)
- the flow rate ratio FRR21/5 of the polyethylene composition (...)  is within the range of 15-28
- the melt flow rate MFR5/190°C of the polyethylene composition (...) is within the range of 0.5-1.1 g/10 min, 
- the composition has a shear thinning index (SHI) (...) within the range of 10-60 (...)

The proprietor had successfully argued that  the flow rate ratio and melt flow ratio ranges do not imply a shear thinning index within the claimed range. The application gives two examples 1 and 2 which do have the required parameters. Unfortunately, the board does not see how the preparation of these examples differs from that of the comparative examples.

The claim is rejected for lack of sufficiency.

Reasons for the Decision
1. The appeal is admissible.

Friday, 9 October 2015

T 1021/11 - Two independent claims for same medical use

In this examination appeal, the main request comprises two independent claims for the same medical indication of the same substance, one claim drafted in the Swiss-type format (use of substance X for the manufacture of a medicament for the treatment of disease Y) and the other claim following the provisions in Article 54(5) EPC (substance X for use in the treatment of disease Y).

In a telephone conversation with the rapporteur, the applicant was invited to comment on the presence of two independent claims for the same medical use in the same set of claims in this request.

The applicant commented that he has a legitimate interest to pursue both claim types in one set because determining the scope of those claims in potential infringement proceedings was a matter for national courts, as confirmed in decision G 02/08. 

In addition, both claim types were deemed allowable by the applicant since the patent application was pending when G 02/08 was issued (and thus the Swiss-type format was allowable) while the transitional provisions concerning the revised Convention Article 54(5) EPC applied to the present application.

Tuesday, 6 October 2015

T 0083/05 - Broccoli III the final

This decision concerns the patent application directed to a broccoli plant with elevated levels of anticarcinogenic glucosinolate derivatives, that was the result of crossing different known broccoli plants and using genetic markers that indicated elevated levels of such glucosinolate derivatives. It is the final of a long lasting case going through two rounds of Enlarged Board of Appeal decisions: Broccoli I (G2/07) and Broccoli II (G2/13, case law blog: here). See also the Tomatoes I and II decisions that concerned similar issues and that were co-decided by the Enlarged Board. 
In this particular decision (which was named Broccoli III) the Board of Appeal reacts to the ruling of the Enlarged Board in G2/13 and of course adapted to that ruling by finding that the claims directed to 'an edible Brassica plant produced according to a method for the production of Brassica oleracea with... etc.'  fulfills the requirements of the EPC. The exclusion of essentially biological processes for the production of plants in Article 53(b) EPC does not have a negative effect on the allowability of a product claim directed to plants or plant material such as plant parts. There is nothing unexpected about this particular decision, but it is important because it generated such important case law.

Smmary of Facts and Submissions
I. Both opponent 01 (appellant I) and opponent 02 (appellant II) filed appeals against the interlocutory decision of the opposition division maintaining European patent No. 1 069 819 in amended form.
II. The appellants submitted that the patent as amended and the invention to which it related did not meet the requirements of the EPC. They relied in particular on the opposition grounds of added subject-matter, lack of enabling disclosure, lack of novelty, lack of inventive step and that the subject-matter of the method claims was not patentable pursuant to Article 53(b) EPC.
III. During the first oral proceedings before this board (albeit in a different composition), the patent proprietor (respondent) submitted a new main and auxiliary request. Claims 1 to 4 of the main request were directed to a method for the production of Brassica oleracea with elevated levels of particular glucosinolates comprising a number of steps of crossing, selecting and backcrossing.
The other claims of the main request were all independent and read as follows:
"5. An edible Brassica plant produced according to the method of any one of claims 1 to 4.

Friday, 2 October 2015

T 595/11: underpayment of appeal fee and still admissable?

A 20% reduced appeal fee was paid by the Appellant (patent owner) who filed a notice of appeal in Dutch, while the patent owner is a legal person in Switzerland. The EPO communicated the file number to the Appellant and the Respondent (opponent) and indicated that the case was referred to a specific Board without any further comments. Later, when the respondent informed the Board that the Appellant was not entitled to the fee reduction, the Appellant paid the remaining portion of the fee and requested that the EPO to accept the late payment of the full appeal fee through the application of the principle of good faith (according to G2/97: the principle of the protection of legitimate expectations). In this case the Board discusses whether the Appellant could have expected that the EPO checked the entitlement to the fee reduction early enough such that the Appellant could have remedied the Appeal, for example, by paying the full fee on time or by filing a request for re-establishment of rights. In response to arguments of the Respondent, the Board had also to consider whether the consequence of its decision would adversely affect one or more parties to the Appeal if the principle of the protection of legitimate expectations applies to this case.

Tuesday, 29 September 2015

T 1461/12 - Inventive step for "mixed inventions"

After a refusal of an application for lack of inventive step based on the approach of T 641/00 (COMVIK), the applicant criticized tat approach in appeal. Assessment of claims involving technical as well as non-technical features, inclusion of non-technical aims as constraints to be met in the problem statement, and earlier case law are addressed in detail in the decision.

Saturday, 26 September 2015

T 285/11 Wrong composition of the Opposition Division

The Board of Appeal discovers that both the first and second examiners of the Examining Division were also present in the Opposition Division. The Board remits the case to the Opposition Division and reimburses the appeal fee because the faulty constitution of the Opposition Division was a substantial procedural violation. The appellant requests that all examiners are replaced as being potentially biased. This request is refused.

Tuesday, 22 September 2015

T 2001/14 - No requests, application refused

This decision shows that filing amended claim sets after receiving an intention to grant R.71(3) is not without risk.

After the applicant had received the intention to grant based on a claim set filed during oral proceedings, new requests were filed.

The Examining division did not allow these new claims and refused to issue new oral proceedings; "without an allowable request on file, the application shall be refused under Article 90(5), Rule 137(3)".

The applicant appealed the decision to refuse and filed a main and two auxiliary requests.  The second auxiliary request is identical to the claims for which the R.71(3) was issued.

The statement of grounds does not discuss Rule 137(3); That is, the statement of grounds does not question if the Examining division was correct not to allow the new auxiliary requests in to the proceedings. The board is tempted to refuse the appeal on this basis as the appeal is unsubstantiated. 

The current version of R.71 is applicable in this case.

Reasons for the Decision

1. Admissibility of the appeal

Friday, 18 September 2015

T 327/13 - Standing and falling as a whole

This opposition appeal is against the Opposition Division's decision to maintain claim 3 as granted (in the context of claim 1 of auxiliary request 1). The appellant considered himself to be adversely affected as by the Opposition Division's decision not to maintain claim 2 as granted. Of relevance in the present case is that claim 2 as granted was not the subject of an individual request in the opposition proceedings, but rather only included as a dependent claim in the main request.

Summary of Facts and Submissions

III. The Opposition Division held that the patent proprietors' main request could not be allowed because the subject-matter of amended claim 1 lacked novelty over D1, but that, account being taken of the amendments in the patent proprietors' auxiliary request 1, the patent and the invention to which it relates meet the requirements of the EPC.

IV. This interlocutory decision has been appealed by the patent proprietors (in the following "the appellants").


IX. The written and oral arguments of the appellants, insofar as they are relevant for the present decision, can be summarised as follows:

The Opposition Division's decision to maintain claim 3 as granted (in the context of claim 1 of auxiliary request 1) is not challenged; however, the appellants are adversely affected by the Opposition Division's decision not to maintain claim 2 as granted, although its subject-matter is novel and inventive in view of D1 (WO 00/35614 A1, filed with the notice of opposition and cited in the decision under appeal).

Clearly the appellants are adversely affected by the Opposition Division's decision to dismiss their main request. It also follows from T 528/93 that, only when a request is withdrawn during the opposition proceedings and re-filed in appeal, is the appellant not adversely affected by the decision of the Opposition Division as far as this request is concerned. In the present case, the appellants did not withdraw their main request and thus, following the reasoning of T 528/93, they are adversely affected by the decision of the Opposition Division to dismiss it.

It is established case law, see for instance T 760/08 (point 2 of the reasons) and T 1708/08 (point 1.3 of the reasons), that the statement of the grounds for appeal satisfies the requirements of Article 108 EPC, third sentence, even if it does not state any specific reason why the decision is contested, provided there is a change in the subject of the proceedings due to the filing of new claims and where the reasons for the decision are no longer relevant in view of the new claims. The appellants filed two new sets of claims which remedy the deficiency of the appellants' main request as identified by the Opposition Division in its decision. Thus, the appeal should be considered as being sufficiently substantiated.

Tuesday, 15 September 2015

T 169/12 - late lines of attack

In appeal against the rejection of the opposition, the opponent submitted new lines of attacked based on documents that were originally mentioned in the notice of opposition, but were never used in any attack before the opposition division. The appellant (opponent) further submitted two new documents in the appeal procedure. Which of the documents and which lines of attack were admitted into the procedure in view of Art. 12 and 13 RPBA?

Friday, 11 September 2015

T 1155/11: the Board introduces a new document - unravelling a web of priority claims


The Board of appeal introduced an additional document that was not mentioned before in the Examination procedure. I didn't see this before and I was surprised. The Board writes in its "Communication of the Board" (dated 3/2/15, sent to the appellant (applicant) together with the invitation to attend oral proceedings):
"The Board notes that in addition to D1 and D2, there are several European patent applications from the same applicant describing subject-matter very close to that of the present application. [...] At least some of those European patent applications have earlier priorities than the second priority date of the present application, 16 April 2003, and describe similar subject-matter. Such applications may be relevant under Article 54(3) EPC in case the first priority date is found to be invalid or to cover only part of the claimed subject—matter."
Subsequently a new document D9 is introduced in the proceedings which claims priority from three priority documents and one of these documents is also a priority application of the patent application that is subject of this Appeal. It seems that, in this decision, the Board tries to unravel the web formed by multiple applications of the same Applicant that claim priority of a multitude of priority applications.
In this decision the subsequent priority claims are relevant:
The patent application that is subject of this appeal is filed on 1 Oct 2003 and claims priority from Korean priority patent application P1 of 17 Feb 2003 and P2 of 16 Apr 2003.
Document D9 (EP1573723), as introduced by the Board, is filed on 1 Oct 2003 and claims priority from Korean priority patent application P3 of 21 Feb 2003, P4 of 3 Mar 2003 and also of P2 of 16 Apr 2003.
If the priority claim from P1 for some of the features of the amended claims from P1 is not valid, and these features are described in D9 and also in one of P3 and P4, then document D9 is an Art. 54(3) EPC document for the amended claims. In the decision a certified translation of P4 and P2 is introduced in the proceedings as respective documents D10 and D11.

Tuesday, 8 September 2015

T 2371/10 - How not to write a claim

Sometimes one may wonder why parties bother to start an appeal procedure (or worse, write a claim and file an application). In this particular case, the applicant did not get past the Examining Division because a severe lack of clarity under Art 84 EPC. The Board did not think differently and the applicant (appellant) did not attend the oral proceedings. Just a good example of how one should not draft a claim. You can read the frustration of the Board in the decision text, and it took them 15 minutes to come to their decision. If someone knows how this HIFU system works, feel free to comment.

Summary of Facts and Submissions
I. The European patent application was refused by a decision of the examining division for reasons of lack of inventive step (Articles 52(1) and 56 EPC 1973) of the subject-matter of claim 1 of each of a main request and three auxiliary requests then on file and of lack of clarity (Article 84 EPC 1973) of claim 1 of the main request.
II. The applicant lodged an appeal against the decision.
The appellant requested that the decision be set aside and that a patent be granted on the basis of a new set of claims 1 to 10 filed with the statement setting out the grounds of appeal. Furthermore, an auxiliary request for oral proceedings was made.
III. The appellant was summoned to oral proceedings to take place on 23 July 2015.
In a communication pursuant to Article 15(1) RPBA the Board commented on the issues to be addressed during the oral proceedings. In this context, the Board pointed inter alia to a variety of clarity problems with the request on file.
IV. The appellant did not reply to the Board's observations nor did it file any further amendments. Instead, the appellant withdrew its request for oral proceedings by letter of 23 June 2015 and informed the Board that it would not attend or be represented at the oral proceedings. In addition, the appellant requested a decision on the state of the file.
V. Oral proceedings were held in the absence of the appellant.
VI. Independent claim 1 of the appellant's request reads as follows :
"1. A high intensity focused ultrasound (HIFU) system for scanning and treating tumor, comprising a combined probe, a high frequency electric power source, a B-mode ultrasound scanner, a multi-dimensional motional apparatus, a vacuum degasser, a therapeutic bed, and a computer operating system, wherein the combined probe comprises:
- a therapeutic head which generates high intensity focused ultrasound; and
- an image-displaying probe of the B-mode ultrasound scanner which is integrated with the therapeutic head,
wherein the combined probe is mounted on the multi-dimensional motional apparatus which comprises a three-dimensional rectangular coordinate and one- or two-dimensional rotational coordinate, the upper end of the combined probe being connected to a central hole of the therapeutic bed through an open water bag;
wherein the open water bag is mounted on the central hole;
wherein the lower end of the open water bag (2) is connected to the head of the combined probe (3);
wherein the combined probe (3) is further connected to the high frequency electric power source (6);
wherein the B-mode ultrasound probe is connected to the B-mode ultrasound scanner;
wherein the motional system (4) is connected to the digit-controlled scanning system;
wherein the open water bag (2) is connected to the vacuum degasser (5); wherein the computer operation system (9) is connected separately to the high frequency electric power source (6), B-mode ultrasound scanner (7), digit-controlled scanning system (8) and the vacuum degasser; and
wherein the therapeutic head can cause a temperature greater than 70 degrees centigrade in a focal region."

Friday, 4 September 2015

T 1436/12 Change of a referenced document

In this appeal following a refusal by the examining division, the Board did not allow a change of reference to a document incorporated by reference as a correction or as an amendment. The applicant had in the application made a reference to a US application identified by the internal patent attorney docket number (the US application number was not yet known). The applicant requested in appeal proceedings to change the reference to a PCT application which claimed priority from the US application. The Board examined the matter thoroughly. One consideration for not allowing the change was that at the moment of filing the European application the US files was not public; so it could not be verified based on the attorney docket number, which was in the US file, which applications were involved.

Tuesday, 1 September 2015

T 943/13 - Not obvious as a food supplement

The opposition division revoked the following second medical use claim:

"1. A soluble dietary fibre for use in the treatment or reduction of the incidence of muscle wasting and/or chronic muscle wasting and/or sarcopenia, the dietary fibre comprising at least 30 wt.% of oligosaccharides having a chain length of 3-10 anhydromonose units."

I understand that document D12 appears to disclose a soluble dietary fibre for use in the treatment or reduction of the incidence of muscle wasting which contains the required oligosaccharides. However, D12 does not disclose that the oligosaccharide prevents muscle wasting. On this basis the board finds the claim inventive. 

To be a bit pedantic, claim 1 does not actually say that it is the oligosaccharides that prevent the muscle wasting, but from the description this is clearly the purpose of including them. 

The board also devotes an interesting discussion to the sufficiency of this broad claim.

Friday, 28 August 2015

T 1273/11 - Provoking appeal

Of interest in this opposition appeal is the request of the respondent that his costs are to be apportioned to the appellant as, according to the respondent, the costs related to the present appeal have been deliberately provoked by the appellant because he withheld relevant material from the first instance proceedings, and therefore prevented the opposition division from taking a complete decision encompassing also this material.

Of further interest is the Board deciding on admissibility of late filed requests, which according to the respondent should be admitted since they are a reaction to the communication of the Board and have been submitted timely before the oral proceedings, such that the appellant had enough time to do a search and prepare for discussing them.

Summary of Facts and Submissions

I. The appellant (opponent) lodged an appeal against the decision rejecting the opposition against European patent EP-B-1 474 347, and requested that the decision under appeal be set aside and that the patent be revoked.

He also submitted further written evidence and offered two new witnesses.

II. The respondent (patent proprietor) requested that the appeal be dismissed, alternatively, that the decision under appeal be set aside and the patent be maintained on the basis of any of the auxiliary requests 1 to 4, filed with the statement setting out the grounds of appeal, or on the basis of any of the auxiliary requests 5 or 6, filed with the letter dated 23 June 2015.

Additionally the respondent requested not to admit the new evidence submitted with the statement of grounds of appeal, and that his costs be apportioned to the appellant.

Wednesday, 26 August 2015

T 1580/13 - Catch-up growth without risk of obesity

Here, the Board sets aside the decision of the opposition division by indicating that no inventive step could be recognized because the prior art that showed that 'catch-up growth' could be achieved using the compounds of the claimed invention. The term 'catch-up growth' was well defined in the specification and could therefore not be taken from other documents. Catch-up growth was in fact defined as a sudden spurt of growth that would result in catching up with subjects having a normal growth, although it may be that the subject would never attain the physical state that it would have reached had the stress not been suffered. Despite the arguments from the proprietor, the Board held that the problem of catch-up growth without an increase in caloric intake, with equilibrated lean and fat body mass and without promoting obesity had not been solved, because such could not be derived from the data in the specification.
Summary of Facts and Submissions
I. This decision concerns the appeal filed by opponent 1 (The IAMS Company), opponent 2 (Abbott Laboratories) and opponent 3 (N.V. Nutricia) against the interlocutory decision of the opposition division that European patent No. 1 940 248 as amended meets the requirements of the EPC.
II. The opponents had requested revocation of the patent in its entirety on the grounds under Article 100(a) EPC (lack of novelty and inventive step), Article 100(b) EPC and Article 100(c) EPC. [...]

Sunday, 23 August 2015

T 557/13 - Referral: Mother poisonous for child?

This case refers five questions to the Enlarged Board of Appeal with respect to what is often referred to as partial priority, poisonous divisionals and poisonous priorities. This case has been discussed earlier in this blog, see our post "T 557/13 - Poisonous or nothing wrong?". 
The opposition decision under appeal relates to a patent that is a divisional from  D1 (which is an EP patent enjoying priority from D16). The divisional also claims priority from D16. The Opposition Division decided that claim 1 of the patent of this appeal case does not enjoy the priority from D16 and, thus, the filing date of D1 is the effective date of claim 1. It may be that the opinion of the Opposition Division is now summarized too much, but, according to the Opposition Division is D1 is an Art. 54(3) EPC document because the effective date of D1 is the priority date of D16, and D1 is published after the effective date of claim 1. 
An additional complication in this case is that claim 1 of the divisional application is a so-termed "generic 'OR'-claim" (see point 8.2.2 of this decision for a definition). Subsequently one could argue that a first portion of claim 1 enjoys priority from D16 and D1 is not an Art. 54(3) EPC document for this first portion, while another second portion of claim 1 does not enjoy priority from D1 and, consequently, the novelty of this second portion must be examined over D1 as an Art. 54(3) EPC document. 
Furthermore, the parties to the appeal proceedings had a diverging opinion about "Can a parent application of a divisional application be a novelty destroying Art. 54(3) EPC document?".
The Board of Appeal could not decide on these subjects because, as extensively discussed in the decision, the case law diverges in different directions. Therefore the Board formulated five questions for the Enlarged Board of Appeal. 

Tuesday, 18 August 2015

T 1279/10 - Deletion of reference to non-public DVD standard: problematic or OK?

The application contained several references to a (non-public) DVD standardization document including references with respect to certain terminology used, such as the term "video cell". The Examining Division required the applicant to delete the references to the (non-public) DVD standardization document. The Examining Division had subsequently refused the application after objections under Articles 83, 84 and 123(2) EPC, as the Examining Divison considered the skilled person to need non-public information to be able to understand the invention, the claims to be not supported by the description, and to extent the meaning of the term "video cell" beyond what was disclosed in the application as originally filed by its meaning no longer being defined by the standard document. The Board of Appeal assessed each of the objections and the assumed necessity of the standard document in detail in view of what is clear to the the skilled person from his common general knowledge and to what extent the invention is applicable to DVD only or broader.

Friday, 14 August 2015

T 217/10 Unsubstantiated auxiliary requests

The Board refuses to examine auxiliary requests I-V. The Board extensively discusses the Rules of procedure of the Boards of appeal and the interpretation thereof. Although the auxiliary requests were filed in time, they were not substantiated such that the Board could not see how prima facie these requests could overcome the objections against the main request. If auxiliary requests are submitted, it usually requires a justification to what extent the objections against the main request are overcome. If the auxiliary requests are not substantiated at filing but at a very late stage, a justification for the late submission is required.

Tuesday, 11 August 2015

T 2049/10 - No clarity or lack of support?

This Examination appeal concerns a decision to refuse a claim solely on the basis of clarity. The refused claim read:

1. A portable computer, comprising:

a display assembly coupled to a base assembly, the base assembly having palm rest areas positioned to support a user's palms;
a touchpad disposed on the base assembly , wherein the palm rest areas are formed by the touchpad,  wherein the touchpad includes a sensor that can detect an object on a surface of the touchpad, and wherein the portable computer estimates a probability that the object detected on the surface of the touchpad is an intentional contact.

Four different clarity objections were raised against this claim: The claim has palm rest areas, but no keyboard. The claim has a 'sensor', instead of a 'hand location sensor'. The claim introduces the surface of the touchpad with 'a surface of the touchpad', which should be 'the'. The claim does not specify the type of input provided by the touchpad that allows calculation of the probability.

The board considers clarity satisfied but considers support instead. Some observations are made regarding the claim that "the invention opens up a whole new field and is entitled to more generality in the claims".

In the end the Applicant settles and includes a keyboard and a hand location sensor in the claim. The application is remitted to allow the Examining division to decide on the inventiveness. 

The following claim is the main request that was eventually remitted:

1. A portable computer , comprising:
a display assembly coupled to a base assembly , the base assembly having palm rest areas positioned to support a user's palms; a keyboard disposed on the base assembly;
a touchpad disposed on the base assembly , wherein the palm rest areas are formed by the touchpad ; and a hand location sensor being able to detect a hand location when a user's hand is positioned on the keyboard ,
 wherein the portable computer filters each contact sensed by the touchpad to either accept the contact as an intentional input command, or reject the contact as unintentional, based on the hand location detected by the hand location sensor."

Friday, 7 August 2015

T 1602/10 - Those generalisation days are truly over

Here, the Board comes to the same conclusion as the ED albeit with another reasoning. Where the ED stated that the patent could not be granted because the disclosure showed that EAE mice treated with anti-TIM-3 antibodies exhibited exacerbated disease, which was not considered a therapeutic benefit and which therefore did not enable the skilled person to carry out the claimed invention (Art 83 EPC) [because an anti-cancer effect was claimed]. The Board on the other hand also denies patentability under Art 83 EPC but because cancer is not a single disease, not all cancers exhibit a TIM-3 mediated immune response and antibodies can have agonistic as well as antagonistic effects. It was concluded that in view of the potentially opposite actions of anti-TIM-3 antibodies, the skilled person would not have considered it plausible that substantially all embodiments of the invention defined in claim 1 were capable of being realised. The treatment of a single antibody in a single type of cancer does in this case not provide evidence in support of the entire scope.
Summary of Facts and Submissions
I. An appeal was filed by the patent applicant (appellant) against the decision of the examining division to refuse European patent application No. 03 723 627. The application, entitled "Compositions and methods related to TIM-3, a Th1-specific cell surface molecule" was filed as an international patent application and published as WO 03/063792.
II. The examining division dealt with a main and an auxiliary request. Claims 5 and 6 of the main request were held to concern an invention which was not disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art, contrary to Article 83 EPC. The same objection was held to apply to the subject-matter of claim 5 of the auxiliary request. These were the sole objections leading to the refusal of the application. The reason given for the refusal was that, although the application disclosed that mice with experimental autoimmune encephalomyelitis (EAE) treated with anti-TIM-3 antibodies exhibited exacerbated disease, this was not a therapeutic benefit and did not enable the skilled person to carry out the claimed invention.
It was held that post-published evidence of reduction of tumour growth in a tumour model by treatment with anti-TIM-3 antibody could not remedy the deficiency because sufficiency of disclosure had to be established at the filing or priority date of the application, as the case may be. Post-published documents could only be used to back up disclosures already made in the patent application but could not establish sufficiency of disclosure on their own.
III. With the statement of grounds of appeal, the appellant submitted a main and three auxiliary claim requests.
IV. With a letter dated 16 February 2015, in response to a communication of the board, the appellant filed a new main claim request replacing all previous claim requests.
V. Oral proceedings before the board were held on 17 March 2015. At the end of these proceedings, the chairwoman announced the decision of the board.
VI. The final request of the appellant was that the decision of the examining division be set aside and that a patent be granted on the basis of the set of claims filed as main request together with the letter dated 16 February 2015.
VII. Claims 1 and 2 of the sole request read:
"1. A TIM-3 binding molecule wherein the TIM-3 binding molecule is an antibody specific for TIM-3 or is a fragment of an antibody specific for TIM-3, for use in the treatment of cancer in a subject.
2. The TIM-3 binding molecule for use as claimed in claim 1, wherein said TIM-3 binding molecule binds to an extracellular region of TIM-3."
IX. The arguments of the appellant can be summarised as follows:
The experimental results disclosed in the application related to administering an antibody against TIM-3 in vivo in a mouse model of experimental autoimmune encephalitis (EAE) which is a model of the human autoimmune disorder multiple sclerosis. In an autoimmune disease a subject's own antibodies react with host tissues or the immune effector T cells are autoreactive to endogenous self-peptides and cause destruction of tissue, i.e. an anti-self response. The inventors discovered that administration of an antibody against TIM-3 resulted in more severe clinical disease and increased mortality in the EAE model. The inventors further found that these animals had increased inflammation in the central nervous system (CNS), and that the demyelinating lesions in the mice treated with antibody to TIM-3 were filled with activated macrophages (Example 6). Further examination of immune cell populations taken from the EAE model mice led to the inventors' discovery that macrophages from mice administered TIM-3 antibody showed increased proliferation and expressed increased levels of MHC Class II antigens, these being indicative of increased ability to present antigen. Both these parameters were measurements of the activation status of a macrophage, which is a type of antigen-presenting immune cell. Together, these data would have been understood by a person skilled in the art to be clearly indicative of an enhanced or increased immune response in animals treated with an anti-TIM-3 antibody. The application therefore demonstrated the suitability of a TIM-3 specific antibody for enhancing an immune response which includes an immune response mounted against a cancer antigen. The enhancement of the immune response by administration of anti-TIM-3 antibodies was of a general and non-specific nature. In the case of cancer, the skilled person knew from the prior art, for example from document D1, that macrophage activation was critical for the induction of immune responses to microbes as well to certain tumor cells. From document D2 (page 207, "Introduction") the skilled person knew that "the monocyte/macrophage system exhibits a wide array of powerful effector mechanisms that may be harnessed for therapeutic effect against infection and malignancy." The specification would have been considered in the light of the knowledge that monocyte-mediated immunity was active against malignancy. Post-published evidence also supported an inherent effect of the TIM-3 inhibitor in cancer models (WT3 sarcoma, TRAP-C1 prostate sarcoma) and some PD-1 blockade synergy (document D3) and EL4 lymphoma (document D4, see page 1386, Fig. 2B). The skilled person would have therefore had no doubt that the invention could be carried out as claimed. On the subject of whether the generation of a de novo immune response by anti-TIM-3 treatment was sufficiently disclosed, the appellant argued that, in fact, no generation of a de novo immune response was needed. The immune system carried out constant immune-surveillance, nascent cancers being naturally disposed of by activated macrophages. Disease was said to arise only when this surveillance failed. Administration of anti-TIM-3 antibodies acted to release a kind of "brake" on the immune system. Finally, it was pointed out that similar claims to second medical uses of compounds for the treatment of cancer in general had been accepted as meeting the requirements of Article 83 EPC, for instance in decisions T 1616/09 of 27 August 2014 and T 1492/09 of 9 January 2014 and T 1918/06 of 10 March 2010.
Reasons for the Decision
Main request [...]
Claim 1
4. The subject-matter of claim 1 is an antibody specific for TIM-3 or a TIM-3 specific fragment thereof, for the specific use of "treatment of cancer in a subject". The claim is therefore directed to a second medical use as foreseen by Article 54(5) EPC.
5. TIM-3 is a transmembrane protein which is preferentially expressed on differentiated Th1 cells and is termed "T cell Immunoglobulin and Mucin domain-containing molecule-3" (see the description of the application, page 1, paragraph 1 and page 2, paragraph 3).
6. The antibody of claim 1, specific for TIM-3 or a TIM-3 specific fragment thereof, may bind different epitopes of the target protein. For instance, claim 2 specifies that the antibody binds to an extracellular region of TIM-3.
7. Antibodies may have different biological effects, depending on their particular binding specificity, for instance, they may be agonistic or antagonistic. The description of the application on page 59 provides several possible explanations of the effect of anti-TIM-3 treatment on a subject: "[...] a cognate interaction between non-T cells and TIM-3-expressing Thl cells is affected by anti-TIM-3 treatment, resulting in the expansion and activation of CD11b+/F4/80+ macrophages. Several possible mechanisms may explain this finding: a) Anti-TIM-3 may cross-link TIM-3 protein on the surface of differentiated Th1 cells in vivo and amplify the production of pro-inflammatory cytokines (e. g., IFN-gamma and TNF), which in turn may induce activation of macrophages ; b) anti-TIM-3 antibody could enhance migration of differentiated Thl cells into the brain where these cells may increase the cellular influx of macrophages from the circulation; c) anti-TIM-3 could block a cognate interaction of TIM-3 with its potential inhibitory ligand on macrophages, thus leading to enhanced macrophage activation in the presence of pro-inflammatory cytokines produced by Thl cells".
8. The mechanism set out under (a) may be seen as an agonistic type mechanism, in which anti-TIM-3 binding triggers a signalling cascade, while that given under (b) is an antagonistic mechanism with the effects due to the blocking of the interaction of a ligand with its receptor.
9. The antibodies of the claim are for the treatment of cancer in a subject. Cancer is not a single disease with a single underlying mechanistic cause but is a collective term for a group of diseases involving abnormal cell growth with the potential to invade or spread to other parts of the body, see the description of the application, page 20, last paragraph: "Cancers include, but are not limited to, basal cell carcinoma, biliary tract cancer; bladder cancer; bone cancer; brain and CNS cancer; breast cancer; cervical cancer; choriocarcinoma; colon and rectum cancer; connective tissue cancer; cancer of the digestive system; endometrial cancer; esophageal cancer; eye cancer; cancer of the head and neck; gastric cancer; intra-epithelial neoplasm; kidney cancer; larynx cancer; leukemia; liver cancer; lung cancer (e.g. small cell and non-small cell); lymphoma including Hodgkin's and non-Hodgkin's lymphoma; melanoma; myeloma; neuroblastoma; oral cavity cancer (e.g. lip, tongue, mouth, and pharynx); ovarian cancer; pancreatic cancer; prostate cancer; retinoblastoma; rhabdomyosarcoma; rectal cancer; cancer of the respiratory system; sarcoma; skin cancer; stomach cancer; testicular cancer; thyroid cancer; uterine cancer; cancer of the urinary system, as well as other carcinomas and sarcomas."
10. In summary, claim 1 is directed to an anti-TIM-3 antibody or a TIM-3 specific fragment thereof, with any type of specificity for treatment of any type of cancer.
Sufficiency of disclosure - Article 83 EPC
11. Article 83 EPC requires that the claimed subject-matter is disclosed in the application "in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art".
12. The experimental evidence provided in the application relates inter alia to mice having experimental autoimmune encephalomyelitis (EAE), a Thl-dependent autoimmune disease being a widely accepted model for multiple sclerosis. The data provided in the examples show that the Th1-specific cell surface protein TIM-3 is involved in regulating the level of T-cell trafficking to target tissues and macrophage activation in these mice (description of the application, page 1, lines 5 to 11 and Examples 5 to 16). Example 6 shows that an existing autoimmune reaction triggered by immunisation with encephalitogenic proteolipid protein (PLP) is exacerbated by administration of an anti-TIM-3 antibody.
13. The board concludes that, from the evidence provided in the application, the skilled person would have considered it plausible that an extant immune reaction, such as that existing in the EAE mice, could be amplified by administration of anti-TIM-3 antibodies.
14. The evidence provided in the application does not concern establishment of a de novo immune response to a tumour antigen or to any other antigen.
15. The skilled person at the priority date knew that
i) cancer cells were "self" cells, ii) an immune response to self antigens was the exception to the rule (cf. description of the application, page 40, lines 7 to 29) and iii) there were a wide range of different cancers with diverse underlying causes (see point 9.9. above).
16. In view of the above it is considered that the skilled person would not have considered that the disclosure of the application makes it plausible that it would be possible to generate a de novo immune response to cancers where there was no established native response. Moreover, the skilled person would not have believed that substantially all cancer types inherently generate a Th1, TIM-3 mediated immune response and be treatable by administration of anti-TIM-3 antibodies. It is noted that the post-published documents submitted by the appellant support this conclusion, see point 23.23. below.
17. Thus, the subject-matter of claim 1 does not meet the requirements of Article 83 EPC with respect to the whole scope claimed in relation to the disease to be treated.
18. Secondly, anti-TIM-3 antibodies do not all have the same specificity or functionality (see points 6.6. and 7.7. above). The particular antibodies used in the examples of the application are termed "8B.2C12" and "25F.1D6" (see Example 1) and were not deposited with a recognised depositary institution according to Rule 31(a) EPC. It was not disclosed in the application whether the interaction of TIM-3 with its not yet identified ligand (see Example 17) was blocked or activated by the antibody to achieve the claimed therapeutic effect. In view of the potentially opposite actions of anti-TIM-3 antibodies, the skilled person would not have considered it plausible that substantially all embodiments of the invention defined in claim 1 were capable of being realised (c.f. Case Law of the Boards of Appeal of the EPO, 7th edition, II.C.6.1.2).
19. Thus, the subject-matter of claim 1 lacks sufficient disclosure to be carried out by the skilled person over the entire claimed scope with respect to the specificity of the anti-TIM-3 antibody to be used in the claimed medical use.
23. With respect to the evidence provided in the form of post-published documents, the board notes that document D3 provides evidence which confirms the board's earlier conclusion (see point 17.17. above) on the insufficiency of disclosure of the application with respect to de novo carcinogenesis. Document D3 reports "an extensive characterization of the therapeutic activity and mechanism of action of an anti-mouse TIM-3 mAb [monoclonal antibody] against experimental and carcinogen-induced tumors" (see the abstract). The anti-TIM-3 antibodies used were specifically antagonistic antibodies (see page 3541, "Tumor models"). Anti-TIM-3 was reported to display only modest prophylactic (page 3546, column 2, final paragraph) and therapeutic activity (page 3547, paragraph 1) against a small fraction of carcinogen-induced sarcomas (13%). In the discussion section (page 3550, column 1) it is stated "We have shown that dramatic therapeutic effects are not observed with monotherapies (including anti-PD1 or anti-TIM3) in this model [of de novo carcinogenesis]. This is despite the fact that anti-PD1 is an extremely promising therapeutic in some human cancers".
24. In summary, document D3 discloses that anti-TIM-3 antibodies fail to successfully treat the majority (87%) of induced sarcomas (see the sentence bridging pages 3546 and 3547).
25. Document D4 reports inter alia that "treatment of EL-4 tumor-bearing mice with anti-TIM-3 Ab resulted in delayed tumor progression coincident with lower frequency of CD11b**(+)Gr-1**(+) cells (Fig. 2B)" (see page 1386, column 2, penultimate sentence).
26. However, in view of the diversity of cancer types (see point 9.9. above), evidence of successful treatment of one tumour type with a specific antibody ("clone 5D12") does not provide evidence in support of the entire scope claimed. Moreover, even if the disclosure of document D4 were to be considered as evidence of the successful treatment of cancer, a particular post-published disclosure relating to a particular antibody and a specific type of cancer cannot remedy a problem of general lack of sufficient disclosure at the priority date (see also decision T 609/02 of 27 October 2004, Reasons 9).
29. In view of the above, the board concludes that the subject-matter of claim 1 is not disclosed in the application in a manner sufficiently clear and complete for it to be carried out by the skilled person and therefore does not meet the requirements of Article 83 EPC.
For these reasons it is decided that:
The appeal is dismissed.
This decision has European Case Law Identifier: ECLI:EP:BA:2015:T160210.20150317 and can be found here. The file wrapper can be found here. Photo "Antibody" (link) by Jim obtained via Flickr under CC BY 2.0 license.