Thursday, March 23, 2023 BREAKING NEWS: G 2/21 decision is out - Plausibility

Today, the Boards of Appeal have published the News message shown below (no changes made, except emphasis added):

Press Communiqué of 23 March 2023 on decision G 2/21 of the Enlarged Board of Appeal

23 March 2023

Background

The Enlarged Board of Appeal is the highest judicial authority under the European Patent Convention (EPC). Its main task is to ensure the uniform application of the EPC.

Technical Board of Appeal 3.3.02 referred questions on the principle of free evaluation of evidence and the notion of "plausibility" in the context of inventive step to the Enlarged Board of Appeal. With regard to the latter, the referring board identified three different lines of case law (see interlocutory decision T 116/18, Reasons 13.4-13.6).

Tuesday, May 12, 2020 T 487/16 - Can a document admitted by the opposition division and upon which the decision was based be excluded from appeal proceedings?

In the present case, an appeal was filed by the appellant (patent proprietor) against the decision of the opposition division revoking his patent due to lack of novelty  w.r.t. D1 and lack of inventive step w.r.t. D3 in combination with late-filed document D7. D7 was admitted by the Opposition Division as prima facie relevant (page 5 of the decision). Arguments of the proprietor before the Opposition Division, that D7 belongs to a remote technical field were not of any avail. In his grounds of appeal, the appellant submitted that "D7 was late filed before the opposition division which then erred in admitting the document despite its content relating to a remote technical field and not being of prima facie relevance to the claimed subject-matter. D7 should thus not have been admitted into the proceedings." Was the Board convinced? Did the Board allow D7 to be used? Did the Board agree with D7 being from an unrelated or remote technical field and did that have any effect on its admissibility or otherwise?

Friday, January 24, 2020 T 1491/14 - A medicament for patients who have ceased use of another medicament due to sleep problems

Sleepless nights

This opposition concerns a medicament whose novel feature is that it is prescribed to particular patients. Claim 1 of the main request reads:

1. A use of 1-[2-(2,4-dimethylphenylsulfanyl)phenyl] piperazine and pharmaceutically acceptable salts thereof in the manufacture of a medicament for the treatment of a disease selected from depression, anxiety, abuse or chronic pain, wherein said medicament is for use in a patient who has previously received another medication for the treatment of said disease which medication was ceased or reduced due to sleep or sexually related adverse events.

The board accepts this as a valid claim. It turned out to be novel but obvious to prescribe the medicament to a patient who has previously received another medication which medication was ceased due to sexually related adverse events, but after limiting the claim to sleep problems it was allowed.  

Tuesday, January 07, 2020 T 405/14 - Closest prior art does not need to be the closest

Which springboard(s) can be used?

In the present opposition appeal case, inventive step was challenged. A key element in the debate was whether the presence of a document D1 which would be closer to the claimed invention than a document D2 would require any inventive step objection to start from D1 as the closest prior art, or whether an attack starting from D2 as the closest prior art would also be admissible and allowable - as well as whether doing so would not only not be correct, but would -if applied by the Examining Division- account to  a substantial procedural violation. "Concerning inventive step, the appellant (applicant) argued that the skilled person would not consider D2 as closest prior art, since it did not disclose magneto-resistive speed-sensors or sensing elements relying on the Hall effect. This appeared all the more true under the present circumstances, considering that document D1 was available. D1 appeared to be a much more suitable starting point, since it addressed problems regarding the testing of speed sensors based on Hall effect or magneto resistive sensors, which was exactly the problem addressed by the claimed invention." The Board came to conclude, with reference to an earlier decision from this same Board, that "Experience teaches that a document which shares a common purpose with a claimed invention, as well as a large number of features, in order to solve the same or a similar problem, will not necessarily allow a convincing objection of obviousness to be raised against that invention, whereas said invention may indeed result, without hindsight, in an obvious manner from an apparently less promising item of prior art. In this respect, all items of prior art considered as starting points which allow the elaboration of a realistic attack under Article 56 EPC may be considered to qualify as "closest prior art", although this currently accepted terminology is somewhat misleading." One could understand this as that this Board seems to consider the term "closest" meaningless. The Board does, unfortunately, not discuss other case law that does give (or at least seems to give) a meaning to the term "closest", e.g., by using terminology such as "most promising" springboard (see e.g. Case Law Book (2019) I.D.3.1 "Determination of closest prior art in general",  3.2 "Same purpose or effect" and 3.4 "Most promising starting point"), nor does the Board comment on its deviations from the quite clear guidance in Guidelines G-VII, 5.1 (despite Article 20(2) RPBA 2007).

Tuesday, May 28, 2019 T 1218/14 - No accidental anticipation; relevant for inventive step?

Does the finding that (a disclosure in) a prior art document D1 does not qualify as an accidental anticipation (thus not allowing the use of an undisclosed disclaimer) because it does not fulfill the criterion laid down in G 1/03 that it is so unrelated to and remote from the claimed invention that the skilled person would never have taken it into consideration when making the invention, imply that it is automatically relevant for inventive step? Or, turned around, if it is found that the claimed subject matter is inventive in view of D1, does this mean that D1 is in fact irrelevant for inventive step, such that the criterion in G 1/03 is met and that D1 is an accidental anticipation after all?

Not necessarily - according to this decision. Herein, the Board argued that the requirement in G 1/03 that an accidental novelty-destroying disclosure has to be completely irrelevant for assessing inventive step is to be understood not as an alternative, or additional criterion, but as a consequence of the criterion that, from a technical point of view, said disclosure is so unrelated and remote that the person skilled in the art would never have taken it into consideration when making or working on the invention.

Consequently, if this criterion is met, it follows that said disclosure is completely irrelevant for assessing inventive step. However, not meeting said criterion does not necessarily imply the opposite, namely that the disclosure in question will contribute to a finding that inventive step is lacking.

Accordingly, in the present case, as D1 was considered to deal with a side aspect of the claimed subject matter, the patentee was not able to maintain his broader claims by disclaiming a relevant disclosure of D1; the subject matter of duly limited claims was however deemed inventive in view of D1 as secondary document.

Tuesday, July 04, 2017 T 578/12 - Dispensing restricted products

 

Many features of the claimed invention were disclosed in an earlier patent application. However, the earlier patent application had no drawings, nor any description of a detailed embodiment of a dispensing machine. To what extent is the earlier application an enabling disclosure?

Tuesday, March 14, 2017 T 0625/11 - How technical is determining a threshold value?

In this appeal from the Examining Division the main question is whether the claimed method of determining a threshold value of an operational parameter of a nuclear reactor, based upon a simulation of the functioning of the reactor, is technical. The Examining Division recognised that the use of a computer made the claimed invention technical in the sense of Art. 52 EPC, but denied inventive step. Discussing the case law, including T 0641/00 (Comvik) and T 1227/05 (Infineon), the Board distinguishes two different approaches. The first approach requires including the functioning of the nuclear reactor to state the technical effect in the claim. The second approach, which is in line with T 1227/05, does not require stating the technical problem in the claim. The Board chooses the second approach and concludes that determining the value of a parameter gives the claim a technical character going beyond the simple interaction between the numerical interaction algorithm and the computer.

Friday, January 27, 2017 T 1379/11 - Combinations of technical and non-technical features

In this appeal against a decision of the Examining Division the claims have a combination of technical and non-technical features and this plays an important role in the inventive step reasoning of the Board. The question is whether the applicant has really added something technical or that the claimed method is an obvious implementation of business requirements in a know technical system. In this case there are also some interesting paragraphs about the selection of the closest prior art - the Board writes "The Examining Division made an attempt to apply both criteria... but failed to do so in a convincing manner.".

Tuesday, August 30, 2016 T 779/11 - In the dark after the search stage

Acting in its capacity of ISA, the EPO issued a declaration under Art.17(2)(a) PCT to the effect that no international search report would be established because no meaningful search was possible. The declaration explained that "[t]he claims relate to subject matter excluded from patentability under Art. 52(2) and (3) EPC [sic]". The declaration further mentioned that a search might be carried out during examination before the EPO should the problems which led to the declaration be overcome. However, the Examining Division refused the application without carrying out a search. It decided on a main request and two auxiliary requests, refusing the main request and auxiliary request 1 for lack of inventive step and not admitting auxiliary request 2 into the proceedings. The applicant appealed and argued, in particular, that the Examining Division's decision not to perform a prior-art search at all was against the established case law of the boards of appeal.
The Board made a clear distinction between the EPO as ISA, and the EPO in the regional phase: acts of the EPO as ISA are not subject to review by the Board. The Board then continued to review whether the claimed subject-matter related to notorious knowledge, which would/could justify to not perform a search and not cite any prior art document. 

Friday, July 29, 2016 T 1742/12 - Close, closer, closest prior art

The most promising springboard?

In this examination appeal, the concepts of 'closest prior art' vs. 'a suitable starting point' in inventive step are discussed. Decisions such as T 967/97 and T 21/08 (also cited in the present case) have tended towards the inventive step having to be assessed relative to all suitable starting points, rather than presuming the existence of one closest prior art document to be used as sole starting point.

In this case, according to the Board's preliminary opinion, the claimed invention lacked an inventive step over D1. With its letter of response, the appellant introduced a document that had been considered in a related case, D6, and argued that given the existence of D6, D1 cannot be closest prior art and that, hence, the inventive step assessment had to start from D6.

The present Board does not follow this line of argument, and rather deliberates that it cannot be true that if a claim is considered obvious with respect to D1, it cannot be rendered non-obvious if a closer prior art, e.g., D6, was found, i.e., an inventive step argument cannot be refuted merely by the introduction of another piece of prior art. Thereby, T 967/97 and T 21/08 are followed.

Tuesday, September 29, 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.

Wednesday, August 26, 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. [...]

Friday, July 10, 2015 T 698/10: Problem not mentioned in closest prior art

The closest prior art and the objective technical problem were disputed because the closest prior art does not mention the problem of the claimed invention. This appeal lies from a decision of the Examining Division to refuse a patent for an invention that relates to the Audio Video Coding Standard of China (AVS). The Board of Appeal clearly discusses the inventive step of the invention. In this discussion the above mentioned objections of the Appellant (Applicant) are discussed extensively. The Applicant also considered his right to be heard violated. The Board also provides a clear discussion of this subject at the end of the decision.

Tuesday, June 16, 2015 T 0275/11: maximum objectivity by the persons conducting the tests?

In this opposition appeal the appellant (patent proprietor) filed results from comparative tests to prove that the "invention" has an advantageous effect. These results were filed to support the inventive step defense that was based on the problem of "providing a better composition for bleaching and/or highlighting keratin fibers [hair]". The Board of Appeal discusses in the decision whether the presented results are based on maximum objectivity. In the decision you can read whether the tests should have a sort of scientific basis or not.

Summary of Facts and Submissions 

(...)

III. The decision under appeal was based on the claims according to the Main Request and Auxiliary Requests 1 and 2. The wording of independent claim 1 of the Main Request read as follows:
"1. Water free composition for bleaching and/or highlighting keratin fibres especially human hair based on at least one compound with bleaching and/or highlighting effect characterized in that it comprises at least one dialkyl carbonate selected from di(caprylyl) carbonate and di(ethylhexyl) carbonate, and a cationic polymer."

(...)

V. With its statement of the grounds for appeal the Appellant defended the patent in suit on the basis of the same requests on which the decision under appeal was based. The Appellant stated that starting from document (1a) as closest state of the art the subject-matter of claim 1 of the Main Request involved an inventive step. As demonstrated with a further comparative Example described in the Appellant's submission the claimed compositions provided improved bleaching and conditioning effects on hair. From the prior art the skilled person had no incentive to use the claimed dialkyl carbonates and a cationic polymer in order to achieve these improvements. Further, document (2) did not refer to bleaching compositions, but only to hair conditioning compositions and would, therefore, not be considered by a skilled person when looking for improving the bleaching and conditioning effects on hair of hair bleaching and/or highlighting compositions.

(...)

With regard to inventive step the Respondent brought forward that the comparative Example referred to in the statement of grounds was not suitable to demonstrate any improvement over the closest prior art document (1a). The Appellant did not provide any information on the qualification of the persons who evaluated the test results. The evaluation of the Appellant, which merely specified that the properties were "very much improved", "much better" and "excellently" cannot be verified and have to be disregarded. The objective problem to be solved could only be seen in providing alternative bleaching and/or highlighting compositions. The solution as proposed by the patent in suit was, however, known already from document (2).
(...)

Reasons for the Decision 

(...)
Main Request 

(...)

3. Inventive step (Article 56 EPC)
3.1 The subject-matter of claim 1 relates to a bleaching and/or highlighting composition for keratin fibres, which effects mild bleaching and good conditioning on hair. A similar composition is disclosed in document (1a), which was accepted as representing the closest state of the art by the Opposition Division and by both parties to the appeal proceedings.

3.2 Document (1a) discloses bleaching compositions for keratin fibres, which effect mild bleaching and provide good conditioning of the treated hair. In the specific embodiment disclosed in Example 1 a water free bleaching cream is prepared, which comprised inter alia 10% by weight of a di(alkyl) carbonate(12,14), 35% by weight of potassium persulfate as bleaching compound and hydroxyethylcellulose as polymer. The cream was in the form of a water free suspension. According to the written statements the parties agreed on this teaching of document (1a). This was not disputed by the parties.

3.3 According to the Appellant the problem to be solved starting from document (1a) consisted in providing a bleaching composition with improved bleaching and conditioning effects on hair.

3.4 As a solution to this problem the patent in suit proposes the compositions according to claim 1, wherein di(ethylhexyl) carbonate or di(caprylyl) carbonate were used as di(alkyl) carbonates and a cationic polymer is present.

3.5 In order to demonstrate that the problem as stated in paragraph 3.3 supra has been successfully solved the Appellant referred to two comparative Examples:

3.5.1 The Appellant argued that the comparative Example referred to in the patent specification in paragraph [0072] showed that the composition according to the invention provides improved bleaching and conditioning effects.
However, the comparative Example of paragraph [0072] does not use any di(alkyl) carbonate and, thus, does not represent a fair comparison with the closest state of the art. Any effects that could be derived from this comparative Example cannot, therefore, support the success of the proposed solution.

3.5.2 In its statement of grounds for appeal the Appellant referred to a further comparative Example, which was based on Example 1 of document (1a). In order to modify this composition to mimic a composition according to the claims of the patent in suit the di(alkyl) carbonate(12,14) of the prior art composition has been replaced by an equal amount of di(ethylhexyl) carbonate and 0.5% by weight of the hydroxyethylcellulose polymer has been replaced by 0.5% by weight of Polyquaternium-10 as a cationic polymer. The comparison was done according to the procedure indicated in the patent in suit, paragraph [0073], using ten volunteers. In view of the results obtained the Appellant stated that in 60% of the cases a "slightly lighter" bleaching effect was obtained with the composition according to the invention. In 80% of the cases the hair treated with the claimed composition "showed a much better combability, hair had very much improved elasticity and hair felt excellently natural and in the remaining 20% of the cases the aforementioned differences were present but at a lower level". Further, in was observed that none of the cases of hair bleached with the composition of document (1a) was found to have improved properties compared to hair treated with the composition according to the present invention.
However, the properties of the treated hair as regards the bleaching were obtained by inspection by eye and conditioning effects and were apparently determined by touching or combing the treated hair. Since this kind of evaluation represents inherently subjective evidence the comparison has to be made under conditions that ensure maximum objectivity on the part on the persons conducting the tests. It is, therefore, desirable to show that the tests have been carried out under "blind" conditions to avoid any suspicion of bias. Further, the testers should indicate the results of their inspection in a detailed manner - either by a detailed report or according to a suitable scoring system - in order to allow the Board and the other parties to evaluate the different opinions objectively (see T702/99, points 2. to 4. of the Reasons).
In the present case the Appellant has not given any information on the identity of the persons evaluating the quality of the treated hair, nor their relationship to the Appellant. No indication was given on the conditions under which these tests were run. Further, in its statement of grounds of appeal the Appellant only gave a summary of the test results, which can assist the Board in its evaluation of the experimental evidence, but which cannot substitute for the detailed information on the individual test results presented either in terms of written statements of each testing person or in terms of tables containing the individual scores given by these testers. Therefore, the Respondent and the Board did not have the information to objectively assess and evaluate the experimental evidence referred to by the Appellant.
In the absence of any information on how this comparative test has been executed and in the absence of the individual test results, any effects referred to by the Appellant have to be disregarded.

3.5.3 Since none of the two comparative tests referred to by the Appellant can support the alleged improvements over the closest prior art, the technical problem as stated in paragraph 3.3 supra above is regarded as having not been successfully solved.

3.6 As a consequence, the technical problem as stated in paragraph 3.3 supra has to be reformulated as to provide an alternative bleaching and/or highlighting composition.

3.7 In order to provide an alternative the skilled person would turn to document (2). This document relates to hair conditioning compositions which are also used for bleaching compositions (claim 7). He knew from this document that cationic polymers and di(alkyl) carbonates, such as di(octyl) carbonate (identical to di(caprylyl) carbonate) are suitable additives to provide hair with improved conditioning effects (see claim 6; page 5, lines 21 to 28; page 3, lines 25 to 29) in compositions for hair treatment, including hair bleaching compositions. The skilled person would thus have arrived at the subject-matter of claim 1 without having to exercise any inventive skill.
The Appellant brought forward that the skilled person when looking for an alternative bleaching and/or highlighting composition would not have considered document (2), since this document does not refer to water free compositions and does only relate to the problem of hair conditioning.
However, document (2) does not only refer to water containing compositions, but explicitly states that the compositions may also be in the form of water free oils, gels, aerosols of sticks (see page 2, lines 22 to 25). Further, the document clearly states that these compositions may be used in bleaching compositions (see claim 6). The fact that one focus of document (2) is the conditioning effect provided by the hair treatment compositions is not sufficient to deter the skilled person from considering its teaching, in particular, since the patent in suit itself aims inter alia at providing improved conditioning effects to the hair.
Therefore, this argument of the Appellant cannot succeed.

3.8 Therefore, the Board concludes that the subject-matter of claim 1 according to the Main Request does not involve an inventive step in the sense of Article 56 EPC.

Auxiliary Requests 1 and 2

(...)

Order

For these reasons it is decided that:
The appeal is dismissed.

This decision has European Case Law Identifier: ECLI:EP:BA:2015:T027511.20150414. The file wrapper can be found here. Photo "wigs" by Steve N obtained via Flickr under CC BY-ND 2.0 license (no changes made).

Wednesday, May 13, 2015 T 995/10 - Purity isn't everything

A clear cut case, wherein the Board of Appeal overrules an earlier decision by the Opposition Division. The decision deals with an aspect in claim 1 that relates to the purity of a virus preparation that is used in cancer therapy. It was indicated in the application as filed and also not disputed by the parties, that a virus preparation should be 'clonal' or as clean as possible, which means that it should have low numbers of defective particles to reduce negative side effects (such as immune responses by the patient). The invention as claimed was directed to the word 'clonal' in the main claim, but unfortunately did not show (in the application as filed) that there was a difference in activity between a clonal preparation and a non-clonal preparation. Post-filed data did not help the proprietor to re-formulate the problem to be solved in the inventive step assessment. Yet another example that it is still wise to have the real data in there, when filing the application, and not simply rely on what might appear logical as the solution to the posed problem, or new formulated problem to be solved.

Summary of Facts and Submissions

I. The appeal of the opponent (hereafter "appellant") lies against the decision of the opposition division rejecting the opposition filed against

European patent No. 1 032 269.

II. The patent at issue has the title "Treatment of neoplasms with interferon-sensitive, clonal viruses".

Claim 1 as granted reads as follows:

"1. Use of an interferon-sensitive, replication-competent clonal RNA virus for the manufacture of a medicament for treating a neoplasm in a mammal." [...]

IV. The opposition division decided that the subject-matter of the claims as granted was novel and involved an inventive step.

V. The following documents are referred to in this decision:

D1 WO 94/25627

[...]

D14 Technical information, submitted by the respondent with letter dated 14 July 2005

[...]

VIII. The parties were summoned to oral proceedings to be held on 11 December 2014. The board expressed its preliminary view in a communication pursuant to Article 15(1) RPBA.

IX. By letter dated 22 October 2014 the respondent announced that it would not attend the oral proceedings.

[...]

XI. The appellant's arguments as submitted in writing and orally may be summarised as follows:

Main (sole) request

Inventive step (Article 56 EPC)

Document D1 represented the closest prior art. The subject-matter of claim 1 differed from the disclosure of document D1 only in the clonal character of the virus population. The technical effect of this difference was, according to paragraph [0079] of the opposed patent: "to ensure or increase the genetic homogeneity of a particular virus strain and to remove defective interfering particles". The objective technical problem was thus the provision of an improved virus-based therapy for the treatment of neoplasms in a mammal, where the improvement consisted in increased purity.

Defective virus particles could cause an unwanted stimulation of the patient's immune system. This was in particular disadvantegous in the treatment of cancer patients due to their usually weak constitution. A high genetic homogeneity of the administered virus particles was moreover desirable for safety reasons, as viruses with deviating sequences could show increased virulence and cause non-reproducible therapeutic effects. These aspects played a crucial role in market authorisation for viral preparations for therapeutic purposes. Hence, it was the constant aim of the person skilled in the field to improve virus-based therapies by reducing the number of defective particles in the virus preparation and by ensuring that the functional virus particles were genetically homogenous. The skilled person would thus be motivated to improve the purity and genetic homogeneity of the virus population disclosed in document D1 and to provide a clonal virus population. Therefore, the skilled person would combine the teaching of document D1 with the virus purification methods disclosed in either document D4 or D11 and arrive at the claimed subject-matter in an obvious manner.

A comparison between a parent virus and a clonal population derived therefrom had not been carried out in the patent in suit. The technical effect - high therapeutic index of the clonal population - allegedly shown in document D14 could not be relied on for the formulation of the technical problem because this effect was neither disclosed in nor derivable from the patent in suit.

Document D12 would not have deterred the skilled person from using a clonal virus population in the treatment of neoplasms in mammals.

XII. The respondent's arguments as submitted in writing may be summarised as follows:

Main (sole) request

Inventive step (Article 56 EPC)

Document D1 represented the closest prior art. In the light of document D1, the objective technical problem was to provide an improved virus-based therapy for treating neoplasms. This problem was solved by the use of an interferon-sensitive clonal virus as defined in the claims of the main request.

Since the examples of the patent demonstrated a credible anti-cancer activity for clonal viruses, the supplementary post-filed evidence provided by document D14 could be taken into consideration. This document, which compared clonal virus strain PV701 and the non-clonal parent strain MK701, showed that clonal viruses resulted in lower mortality of non-cancer cell types and a higher therapeutic index. The principal concept underlying the claimed invention was that clonal viruses demonstrated lower cytotoxicity to normal cells than non-clonal viruses.

Starting from document D1, the skilled person would have found no suggestion to use a clonal virus for the treatment of neoplasms. Even if in view of document D1 a skilled person could have produced a clonal virus, the question was whether he would have done so in the expectation of some improvement. Also, there was a general acceptance in the art that viral therapies should use non-clonal viruses, see for example document D12, page 1, last paragraph, which confirmed that NDV vaccines should use uncloned NDV. Hence, the skilled person seeking to prepare an improved anti-cancer therapy would have been led towards the use of a non-clonal virus.

XIII. The appellant requested that the decision under appeal be set aside and the patent be revoked.

The respondent had requested in writing by letter dated 10 December 2010 that the appeal be rejected in its entirety, i.e. that the patent be maintained as granted.

Reasons for the Decision

[...]

Main (sole) request

Introduction

3. The patent in suit concerns the treatment of mammalian neoplasms with viruses that are able to cause the death of neoplastic cells which have a deficiency in the interferon-mediated anti-viral response while normal cells which possess an intact interferon-mediated anti-viral response limit the replication of the virus and are not killed. The viruses are RNA viruses, in particular paramyxoviruses such as Newcastle Disease Virus (NDV).

Inventive step (Article 56 EPC)

[...] 5. It is common ground between the parties that document D1 represents the closest prior art with respect to the claimed subject-matter. Document D1 (see paragraph bridging pages 3 and 4; page 10, lines 11 to 15; examples) discloses a method of treating cancer in mammals by administering to the mammal an effective amount of a paramyxovirus. In a preferred embodiment the virus is NDV. The document discloses that NDV has direct cytolytic activity on the cancer cells and is capable of specifically differentiating cancer cells from normal, healthy cells. It is reported that one dose of NDV, given intralesionally to athymic mice, causes complete and permanent eradication of a wide variety of human tumours. Document D1 thus relates to the same purpose as the patent in suit - the treatment of cancer using interferon-sensitive, replication-competent RNA viruses capable of selectively killing neoplastic cells - and discloses one of the preferred viruses of the patent in suit, namely NDV.

The technical problem to be solved

6. There was no dispute among the parties that the subject-matter of claim 1 differed from the disclosure of document D1 only in the feature relating to the clonal character of the virus population. [...]

9. The board notes that the patent in suit does not compare the efficacy of the parent non-clonal virus and a clonal population derived therefrom. Pursuant to paragraph [0074] of the patent in suit the viruses of the invention possess the following three characteristics: "(i) they infect neoplastic cells resulting in their death; (ii) they are replication-competent in the neoplastic cells; and (iii) they are limited in killing of normal cells by the antiviral effects of interferon". This passage refers to the specific cytotoxicity of the viruses of the invention towards neoplastic cells, but not to a possible advantage of cloned versus uncloned virus populations. Indeed, the mention of "limited killing of normal cells" in this paragraph applies to any interferon-sensitive virus regardless of its clonality because, unlike neoplastic cells which are deficient in an interferon-mediated anti-viral response, normal healthy cells possess an intact interferon-mediated anti-viral response which protects them from virus-induced cytolysis, see paragraph [0050] of the patent in suit.

10. Accordingly, document D14 can not be relied on for the formulation of the technical problem because the technical effect shown in document D14 is neither disclosed in nor derivable from the patent in suit (see Case Law of the Boards of Appeal of the EPO, 7th edition 2013, section I.D.4.4.1).

11. It follows from points 7 to 10 above that starting from document D1 the problem to be solved is the provision of an improved virus-based therapy for the treatment of neoplasms in a mammal. The board is satisfied that the solution provided by the subject-matter of claim 1 solves this problem.

Obviousness

12. It remains to be answered whether or not the skilled person, when faced with the technical problem defined in point 11 above, would have modified the teaching in the closest prior art document D1 so as to arrive at the claimed invention in an obvious manner.

13. The prior art describes the provision of clonal sub-populations of NDV strains by plaque purification, see document D4, page 435, third full paragraph, and document D11, page 116, lines 1 to 3.

14. Moreover, as submitted by the appellant, the skilled person would have known that the regulatory approval of any virus-based therapeutic composition would require detailed information indicating that the composition was safe and that the therapeutic effect was reproducible. For this it was necessary to provide a virus population which was devoid of defective particles which could cause an unwanted stimulation of the patient's immune system. A high genetic homogeneity of the administered virus particles was also desirable for safety reasons, as viruses with deviating sequences could show increased virulence and cause non-reproducible therapeutic effects. The respondent has not disputed this line of argument. [...]

16. The board is not convinced that document D12 would have deterred the skilled person from using a clonal virus population in the treatment of neoplasms in mammals. The paragraph relied on by the respondent states that "[w]e must be aware that the populations of Newcastle disease virus that spread in the field, or the populations that make up a vaccine stock [note by the board: the NDV vaccine for use in chickens] are not clonal". In the board's view this corresponds to what was known in the art at the priority date, namely that "both wild-type isolates and laboratory cultured strains of Newcastle disease virus contain several subpopulations", see document D11, page 113, first paragraph. A requirement that NDV should be uncloned when used in mammals, not in chickens, and for the treatment of neoplasms, and not as a vaccine, is not apparent from document D12.

17. Starting from the teaching of document D1 and faced with the problem of providing an improved virus-based therapy for the treatment of neoplasms in a mammal, the skilled person aware of the non-clonal character of NDV strains and of the regulatory requirements for obtaining marketing authorisation for viral preparations for therapeutic purposes would have readily considered providing a clonal virus population by plaque-purifying the NDV strain of document D1 pursuant to the teaching of document D4 or D11. He would thus have arrived at the subject-matter of claim 1 in an obvious manner. [...]

Order

For these reasons it is decided that:

1. The decision under appeal is set aside.

2. The patent is revoked.

This decision has European Case Law Identifier: ECLI:EP:BA:2014:T099510.20141211. The whole decision can be found here. The file wrapper can be found here. Picture by GH.

Tuesday, March 17, 2015 T 0117/10 - Tempus fugit

Calendar app

After two appeals and ten years of prosecution the applicant in this software case has now been awarded a grant (well, nearly..). 

The application concerns a calendar application with a novel cache function (a 'moving cache'). 

The application was refused for the first time in 2006. According to the (then) Examining division the implementation of a cache to 'represent one out of several straightforward possibilities from which a person skilled in the art would select, without the exercise of inventive skill, (...)'. In previous letters the cache management scheme was found 'to relate to pure business issues regarding the management of events, and the conflict notification functionality.' Though the latter consideration was not part of the decision.

With an appeal (T 1265/06) the applicant won a remittal on 15.04.2009. The board had found that 
'the examining division did not cite a single prior art document which was related to the use of a
cache in a handheld device' and that  the 'main request can thus be allowed on the condition that the
description is adapted accordingly.' The appeal decision did not include a order to grant though.

The Examining division cited new documents and in a decision on the file, rejected the application on 1.12.2009. In the new refusal, the Examining division argued that 'the application variables (located in the memory) which are loaded through a database fetch already are the cache. It is noted that such a database fetch is implicit to any database access.'


After the new appeal, part of which is reproduced below, the applicant has won a new remittal, this time with an order to grant.


Reasons for the Decision
1. The appeal is admissible and allowable since in the Board's judgement the decision under appeal does not prove to the necessary standard the lack of inventive step and there are no other objections against the application as it stands apparent from the file. This holds for the claims of the main request, the description as amended with the statement of grounds and the drawing as originally filed.

2. The Board agrees with the appellant that the new documents cited do not improve the relevance of the available prior art. In particular, the decision under appeal fails to substantiate the leading argument that use of a "moving cache" in a handheld computing device is prior art. In the preceding decision T 1265/06 (see point 5 of the reasons), the Board stated that "the examining division did not cite a single prior art document which was related to the use of a cache in a handheld device, let alone something like a 'moving cache' for implementing the calendar application on a handheld device". This factual situation has not substantially changed in spite of the efforts of the examining division to produce more relevant prior art.

Tuesday, March 10, 2015 T 1122/11 - Close, closer, closest prior art

This decision shows that it may be useful to appeal a refusal of an application, and show that the initial closest prior art in an inventive step rejection should actually not have been considered to be the closest prior art. Starting from another closest prior art document, the result here was that the appeal board came to different conclusion than the examining division (and in fact agreed with the applicant).
Besides that, for readers that may struggle with the meaning of blood, blood-based sample, blood sample, serum sample, plasma sample, blood-derived sample, etc., this decision clarifies that one can never be too careful in describing in the application as filed what samples are being used, since these terms are certainly not readily exchangeable. The components in blood are multifold and endless different kinds of blood-based samples may possibly be used, according to the board.

Summary of Facts and Submissions

I. The appeal lies from the decision of the Examining Division announced at oral proceedings on 1 December 2010 refusing European patent application No. 07 754 043.3.

Claim 1 of the application as originally filed read as follows:

"1. A method of determining whether a patient will be responsive to a drug or treatment, the method comprising:

obtaining a test spectrum produced by a mass spectrometer from a serum produced from a patient having a disease;

processing the test spectrum to determine a relation to a group of class labeled spectra produced from respective serum from other patients having a same or similar clinical stage disease and known to have responded to or not responded to a drug or treatment; and 

determining, based on the relation of the test spectrum to the group of class labeled spectra, whether the patient will be responsive to the drug or treatment."

Wednesday, February 11, 2015 T 2540/12 - extrapolation of disclosure closest prior art

This appeal lies from a decision of the Opposition Division filed by the opponent. The Opposition Division maintained the patent as granted and the opponent (Appelant) filed the appeal. In this appeal there was an interesting discussion about inventive step. The subject of the discussion was whether the skilled person would extrapolate results of a scientific study presented in the closest prior art such that he arrives at an embodiment falling within the scope of the main claim of the main request. The study addressed the effects of an early diet of infants on their later life. One has to realize that the effect of the main claim is not really different from the effect of the disclosure of the closest prior art. Another interesting point of this decision is the admissibility of an auxiliary request introduced at the end of the oral proceedings while the same request was withdrawn earlier during the same oral proceedings.

Summary of Facts and Submissions
 
(...) 


III. The opposition division's decision was based on the claims as granted, of which claim 1 reads as follows:"1. Use of nutrient in the manufacture of a feeding formula for feeding to human infants in the period up to 2 months of age to avoid long-term adverse health effects consequent upon excessive weight gain in that period, wherein said feeding formula comprises 0.5 to 1.00 grams of protein and 25-50 kilocalories per 100 ml."

The subject-matter of claim 1 differed from the closest prior art document D1 in that a feeding formula was used comprising 0.5 to 1.00 grams of protein and 25 to 50 kilocalories per 100 ml. The objective technical problem was seen as how to find a feeding routine for early postnatal nutrition that reduced the risk of long-term adverse health effects consequent upon excessive weight gain caused by using infant formulae. It was credible that the technical effect of reducing long-term adverse health effects upon excessive weight gain was achieved by the feeding formula as required in granted claim 1. D1 acknowledged a relationship between nutrient-enriched diets given to neonates and obesity in later life. There was however no teaching in D1 to modify existing feeding formulae according to claim 1. D1 merely suggested that breastfeeding was preferable for obtaining the long-term benefit on adiposity. The opponent's argument that the experimental data in D1 would lead the skilled person in an obvious way to the claimed solution in the same way as the experimental data of the opposed patent was not considered to be convincing as this reasoning would be based on hindsight knowledge of the invention. The subject-matter of claim 1, formulated as a plausible prediction on the basis of the experimental data in the contested patent, indeed appeared logical a posteriori. However in the absence of a pointer in D1 to reconsider the energy and protein requirements of commercial feeding formulae in order to solve the above-mentioned objective technical problem, the skilled person would not have arrived at the claimed solution in an obvious way.

(...) 

XII. So far as relevant to the present decision, the appellant's arguments can be summarised as follows:
- Main request
The claims of the main request were not based on the application as filed and the invention defined in these claims was not sufficiently disclosed.
Furthermore, the subject-matter of claim 1 was not inventive in view of D1 as the closest prior art. The formula of claim 1 differed from those disclosed in D1 in that the protein and energy content was slightly lower. No data were contained in the opposed patent as to the claimed formula and no effect had been attributed to the slight reduction in protein and energy content. Hence it had to be assumed that the formula of D1 provided the same effect as that of claim 1. Therefore the objective technical problem solved in the light of D1 was the provision of an alternative composition to achieve the same therapeutic effect. D1 already pointed at lowering the protein and energy content since lower protein and energy contents let to lower leptin concentrations and hence less risk of obesity in later life. In this respect, trial 2 of D1 was relevant, in which the use of a non-enriched standard term formula instead of the preterm formula led to a reduction in the leptin concentration of 29%. In view of the respondent's arguments made during the discussion of sufficiency of disclosure (see point 2.5 below), it had to be assumed that the skilled person would extrapolate the trend observed in this trial towards even lower protein and energy contents, such that he would arrive at the subject-matter of claim 1.

(...)

XIII. So far as relevant to the present decision, the respondent's arguments can be summarised as follows:- Main request
D1 was the closest prior art, from which the claimed formula differed in terms of the protein and energy content. The objective technical problem was how to avoid in formula-fed infants the risk of creating long-term adverse health effects. There was no significant difference in D1 between formula-fed infants and infants that had received breast milk, and between infants having received the preterm formula and those having been fed banked breast milk. The skilled person would thus not have been motivated to change the composition of the preterm and term formulae in D1. Furthermore, it was commonly known that breast milk was the "gold standard". Therefore, the fact that the preterm formula in D1 was less beneficial than mother's own expressed breast milk would not induce the skilled person to modify the preterm formula. Also the authors of D22 had realised that formula-fed infants had a higher fasting insulin concentration than breastfed infants but had not suggested modifying the formulae. Finally, there was nothing about insulin resistance in D1 and the skilled person would thus not have been motivated to choose the claimed formula to avoid insulin resistance.

(...)

Reasons for the Decision
 
(...) 

2. Inventive step

2.1 The invention underlying the opposed patent relates to the use of infant formulae to avoid long-term adverse health effects consequent upon excessive weight gain (paragraphs [0006], [0007] and [0010] and claim 1 of the patent).

(...)

2.2 D1 is a scientific paper published by a group of authors including the two inventors of the opposed patent. In the same way as in the patent, this paper is dealing with the effects of early diet on later life. The study described in D1 is exactly that disclosed in the patent, i.e. the infant group, study design and formulae (a) to (d) applied in the study of the patent are used in D1 as well (as regards infants and study design of feeding the infants, see paragraph bridging left- and right-hand column on page 994; as regards formulae, see the first full paragraph on the right-hand column of page 994; as regards the study design of the follow up, see the first paragraph on the left-hand column on page 995). The only difference between the study in D1 and that in the opposed patent is that in D1 the relative leptin concentrations indicative for obesity in later life are measured in the follow up (abstract on page 993 and conclusions on page 998), rather than the 32-33 split proinsulin concentration and the flow-mediated endothelial dependent dilation (FMD) in the patent.
D1 is thus in the same technical field and aims at the same objective as the opposed patent. As acknowledged by both parties, D1 therefore can be considered to represent the closest prior art.
In the same way as the diets used for the examples in the opposed patent, the diets used in D1 are different from the formula defined in claim 1 of the opposed patent in that the protein and energy contents in D1 are slightly higher than those of the formula according to claim 1.

2.3 According to the respondent, the problem solved by the patent was how to avoid, in the case of formula-fed infants, the risk of creating long-term adverse health effects.

2.4 As a solution to this problem, the patent proposes the use according to claim 1, characterised in that an infant formula is applied with a slightly lower protein and energy content than that present in the term formula of D1, namely 0.5-1.00 g/100ml of protein and 25-50 kcal/100ml.

2.5 It needs to be examined whether this problem has been credibly solved by the claimed subject-matter, i.e. by the lower protein and energy contents required by claim 1.
During the discussion of sufficiency of disclosure during the oral proceedings before the board, the respondent explained that the skilled person looking at the experiments in the study described in the opposed patent would have reasonably expected that the trend observed in this study, namely that lower protein and energy contents led to lower insulin resistance and endothelial dysfunction, could be extrapolated to the even lower protein and energy contents required by claim 1. In other words, the skilled person would have expected that at these even lower protein and energy contents, insulin resistance and endothelial dysfunction would be avoided.
The board accepts this argument and therefore considers it to be credible that the above problem (point 2.3) is solved by the subject-matter of claim 1. This problem thus represents the objective technical problem.

2.6 It needs finally to be examined whether in view of this problem, the claimed solution is obvious.

2.6.1 In trial 2 of D1, children fed the term formula were compared to children fed the preterm formula (figure 1 on page 994). It was found that children who had received the term formula (with a lower protein and energy content, see point 2.1.1 above) had a leptin concentration at the age of 13 to 16 years that was 29.0% lower than children who had received the preterm formula (trial 2 in table 3 on page 997 and lines 10 to 16 of the left-hand column on page 998 of D1), and this correlated to a lower risk of obesity in later life (lines 4 to 6 of the right-hand column on page 997 of D1).
Hence, exactly the same trend is described in D1 as in the patent, namely that a lower protein and energy content of the term formula reduces adverse health effects in later life (obesity in D1 and insulin resistance and endothelial dysfunction in the opposed patent).

2.6.2 Accepting the respondent's argument that in the patent this trend can be extrapolated to lower protein and energy contents as required by claim 1, which the board does (point 2.5 above), the same must be assumed for D1. More specifically, in the same way as for the study described in the patent, it must be assumed that the skilled person reading D1 would expect that by reducing the protein and energy content of the term formula in D1 even further, the risk of obesity in later life would be avoided. The skilled person seeking to achieve this avoidance would thus reduce the protein and energy content of the term formula of D1 and would thereby arrive at the subject-matter of claim 1. This subject-matter is therefore obvious in view of D1.

2.7 The respondent's arguments made as regards inventive step are in this respect not convincing:

2.7.1 The respondent argued that there was no significant difference in D1 between formula-fed infants and infants that had received breast milk and between infants having received the preterm formula and those having been fed banked breast milk. The skilled person would thus not have been motivated to change the composition of the preterm or term formulae in D1.
However, this argument is not relevant since D1 contains a comparison of infants fed with a term formula and those fed with a preterm formula and since, as has been set out above, in view of this comparison the claimed subject-matter is obvious.

2.7.2 The respondent also argued that it was commonly known that breast milk was the "gold standard". Therefore, the fact that the preterm formula in D1 was less beneficial than mother's own expressed breast milk would not induce the skilled person to modify the preterm formula. Also the authors of D22 had realised that formula-fed infants had a higher fasting insulin concentration than breastfed infants but did not suggest modifying the formula.
However, in the same way as for the respondent's first argument, this argument disregards the fact that D1 contains a comparison between a preterm and a term formula and that, on the basis of this comparison, the claimed subject-matter is obvious.

2.7.3 The respondent further argued that there was nothing about insulin resistance in D1.
This argument is not relevant either since claim 1 is not restricted to the avoidance of insulin resistance but covers the avoidance of adverse health effects in general.

2.8 The subject-matter of claim 1 therefore lacks inventive step in view of D1.

(...)

Auxiliary request

4. Admissibility

4.1 The auxiliary request (hereinafter "new auxiliary request") was filed at approximately 2.50 pm during the oral proceedings before the board. Pursuant to Article 13(1) RPBA, it is at the board's discretion to admit or not to admit the new auxiliary request. This discretion shall be exercised in view of inter alia the need for procedural economy. When exercising this discretion, the board has to take into account the respondent's behaviour during the oral proceedings (T 1790/06, point 16). To decide on the admissibility of the new auxiliary request, it is therefore necessary to reiterate the course of the present oral proceedings, including the respondent's latest written submissions.

4.2 With letter dated 17 December 2014, the respondent had filed two auxiliary requests, namely an AUXILIARY REQUEST and an AUXILIARY REQUEST 2 (see point IX above). Oral proceedings were held on 13 January 2015 and started with the discussion of the respondent's main request. After the board had announced its opinion that the main request was not inventive, the respondent withdrew its AUXILIARY REQUEST filed with letter of 17 December 2014. Subsequently, the admissibility of AUXILIARY REQUEST 2 was discussed, focusing on problems arising due to the amendment of the time period defined in claim 1. This AUXILIARY REQUEST 2 was again withdrawn and new auxiliary requests 2 and 3 were filed. The admissibility of these two requests was then discussed, again focusing on problems concerning the now differently amended time period in claim 1. Also these auxiliary requests were subsequently withdrawn and at approximately 2.50 pm the new auxiliary request was filed.
The new auxiliary request is in essence identical to the AUXILIARY REQUEST filed with letter of 17 December 2014 but then withdrawn in the oral proceedings. The filing of the new auxiliary request thus essentially represents a re-introduction of the withdrawn AUXILIARY REQUEST, after several hours of discussion on several other also later withdrawn auxiliary requests. Because of the way in which the requests were filed and later withdrawn, the discussion during the oral proceedings went in circles, such that the conduct of the oral proceedings became very inefficient. The respondent thereby did not comply with its duty as regards the efficient conduct of the oral proceedings (T 1790/06, point 16).

4.3 The respondent argued that proceedings before the boards of appeal were about giving justice to all parties and the oral proceedings should therefore be conducted so as to find out whether the new auxiliary request was allowable.
(...) 
The board accepts that the way the respondent acted during the oral proceedings did not entail any devious intent. Nevertheless, as set out above, the respondent's behaviour impaired the efficient conduct of the oral proceedings and this in itself was sufficient reason not to admit the new auxiliary request.

4.4 The board therefore decided not to admit the new auxiliary request into the proceedings.

(...)

Order

For these reasons it is decided that:
1. The decision under appeal is set aside.
2. The patent is revoked.

This decision has European Case Law Identifier: ECLI:EP:BA:2015:T254012.20150113. The whole decision can be found here. The file wrapper can be found here. Comic obtained from xkcd.