T 2046/19 - Combining in vivo and in vitro diagnostics

Key points

• Claim 1 reads as follows: ""1. A method for the prognosis .... of patients with COPD the method comprising the steps of:

  i) providing a sample of a bodily fluid from said patient, ii) determining in said sample the level of at least one biomarker, selected from the group consisting of proadrenomedullin (proADM), pro-natriuretic peptide, pro-Vasopressin (proAVP) and Procalcitonin (PCT) or fragments thereof of at least 12 amino acids in length, [and]

  iii) determining the BODE-index parameters according to one of the following steps:

  iii-a) determining the BODE-index parameters body-mass index (BMI, parameter B), degree of airflow obstruction (FEV1, parameter O), and dyspnea (parameter D), omitting the BODE-index parameter exercise capacity (parameter E);

  iii-b) determining the BODE-index parameters body-mass index (BMI, parameter B) and dyspnea (parameter D), omitting the BODE-index parameters exercise capacity (parameter E) and degree of airflow obstruction (FEV1, parameter O);

  iv) correlating said level of said at least one biomarker determined in step ii), in combination with said BODE-index parameters determined in step iii-a) or in step iii-b) to the prognosis and/or risk assessment and/or monitoring of therapy and/or management of patients with COPD."'

• The patent was opposed. The Board considers the claim to be insufficiently disclosed.
• However, my question initially was, how is a claim reciting 'determining dyspnea' (shortness of breath) not be a diagnostic method under G 1/04? 
• The answer is probably r.9 of G1/04: "The grant of a European patent in respect of a diagnostic method which includes preceding method steps of a technical nature carried out by a device (cf. point 6.4.3 above) does not contravene Article 52(4) EPC, because the performance of the respective method steps does not satisfy the criterion "practised on the human or animal body". However, in the event of patent protection, it will normally be sufficient to purchase the device in question in order to be entitled to carry out such a method [*] In cases where the same diagnostic conclusions can be attained by a method not including the use of the device, those carrying it out will not be inhibited by the patent. Therefore, the medical or veterinary practitioners cannot be considered to be hampered by the existence of such a patent."
• [*] - the Enlarged Board refers to the national case law and rules about exhaustion and implied licences. 
• Hence, a method of in vitro diagnosis is still patentable even if combined with an in vivo diagnostic test, according to this decision; it seems.
• "the so-called "BODE index" was known as a tool for the prognosis of mortality and hospitalisation for COPD in patients with COPD."
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EPO 

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

https://www.epo.org/en/boards-of-appeal/decisions/t192046eu1

1. Sufficiency of disclosure - main request

1.1 The requirement of sufficiency of disclosure must be satisfied at the effective date of the patent, i.e. on the basis of the information provided in the patent application as filed, together with the common general knowledge then available to the person skilled in the art. In the following analysis, where the board refers to passages of the opposed patent, the same content is also found in the text of the application as filed.

Technical background

1.2 The opposed patent relates to the individual risk-assessment of patients with COPD (chronic obstructive pulmonary disease). A patient diagnosed with COPD may be in a stable or unstable (acute exacerbated) state of the disease (see also dependent claim 5). The goals of COPD assessment are to determine the severity of the disease, its impact on a patient's health status, and the risk of future events (exacerbations, hospital admission, death) in order to guide therapy (see paragraph [0004] of the opposed patent).

1.3 As set out in the opposed patent (see paragraphs [0006] and [0029]), the so-called "BODE index" was known as a tool for the prognosis of mortality and hospitalisation for COPD in patients with COPD. It combines four variables into a single score. These parameters are:

B: body-mass index

O: degree of airflow obstruction, measured by lung-function testing (FEV1)

D: dyspnea

E: exercise capacity, measured by the six-minute walk test

Depending on the respective measurement results, scores are assigned to the patient for each parameter (see table 2 in the opposed patent). The sum of these scores is the BODE index. It reflects the impact of both pulmonary and extrapulmonary factors on prognosis and survival in COPD, with higher scores indicating greater risk.

1.4 However, determination of the BODE index is cumbersome as it requires a 6-minute walk test in the stable state of the disease, and it is not suitable for acute exacerbations (see paragraph [0006] of the opposed patent).

1.5 Thus, there had been increasing interest in using other parameters, including pulmonary biomarkers, to monitor disease severity in patients with COPD (see paragraphs [0006] to [0008]). It was known, for instance, that certain biomarkers, such as procalcitonin, are increased during exacerbations. Systemic biomarkers were also known to be of interest as a means of determining disease severity and prognosis in stable COPD. However, information was still scarce as to the prognostic value of these biomarkers.

Objective and claimed subject-matter

1.6 The opposed patent (see paragraph [0009]) seeks to provide a method for easy and reliable prognosis and/or risk assessment and/or monitoring of therapy and/or management of patients with COPD, with minimum inconvenience for the patient.

1.7 More specifically, it is suggested that such a method should replace part of the conventional determination of the BODE-index parameters, with a view to reducing the burden on the patient.

1.8 To this aim, and as defined in claim 1 as granted (see point I. above), several predictor parameters are to be determined:

- the level of at least one biomarker, selected from a specified group of eligible biomarkers, in a sample of a bodily fluid of a patient with COPD (claim 1, steps i) and ii))

- selected parameters of the BODE index (claim 1, step iii), namely:

(a) either three parameters (BOD) are to be determined, omitting parameter E

(b) or two parameters (BD) are to be determined, omitting both parameters O and E

These parameter values determined for the individual patient are to be combined and "correlated to" the prognosis and/or risk assessment and/or monitoring of therapy and/or patient management, which is both the purpose and the effect of the method (claim 1, step iv); see also paragraphs [0001] and [0009] to [0012] of the opposed patent).

1.9 The board understands this to mean that the assessment made for an individual patient (which is the claimed method's stated purpose), on the basis of this patient's parameter values obtained according to steps i) to iii), will be based on a known relationship (i.e. a correlation) between a combination of the specific parameters chosen and a relevant clinical outcome that is to be considered for the analysis. Hence, this general correlation, which will be applied in step iv) to the patient's individual parameter values, must of necessity have been established before carrying out the claimed method on individual patients. Otherwise it would not be possible to determine which parameters should be measured according to steps i) to iii).

1.10 The claimed method is defined functionally by its result. This result is defined only indirectly, in a general and rather broad manner, in that the method must enable prognosis, risk-assessment, therapy monitoring and/or management of patients with COPD. The crucial step for achieving this purpose is step iv).

1.11 While there is no doubt that the person skilled in the art would know how to collect parameter values according to steps i) to iii), claim 1 does not say how step iv) is to be put into practice. In particular, the claim does not specify how to choose the contributing parameters in the first place, how to combine the parameter values in practice and how to establish and use a correlation of these combined values to a particular outcome to achieve the defined purposes of prognosis, risk assessment, monitoring of therapy and patient management.

1.12 The prognosis or risk assessment addressed in claim 1 has to relate to a specific clinical outcome. On the basis of this prognosis or assessment, measures for therapy monitoring (such as testing for particular parameters, increasing or reducing the frequency of tests) or patient management (such as decisions about medication or hospitalisation) can then be determined.

T 0686/22 - Does the Board play games?

Key points

• The applicant is Nintendo.
• "The [claimed] apparatus [i.e, the gaming device] ]is provided with a restriction process means which restricts the number of players permitted to play a multi-player game when the apparatus display means is used rather than an external TV"
• "In its [preliminary opinion] the Board discussed for the first time the Nintendo Wii U system with its Wii U game console and Wii U GamePad operator device as prior art, in particular with reference to Nintendo customer support documentation for a Minecraft game, available on-line at the time of writing the communication. The Board will refer to this collectively as D4."
• The Board refers to "https://en-americas-support.nintendo.com/app/answers/ detail/a_id/15831/~/how-to-start-a-multiplayer-game-%28minecraft%3A-wii-edition%29#:~:text=How%20to%20Start,mode%20will%20begin" (a page that no longer exists).
• From the preliminary opinion:  "the appellant-applicant will undoubtably be aware of the Wii U game console (released 2012) with its Wii U gamepad. The Wii U gamepad has its own screen which can be used to display game play. It can also be connected to an external screen by HDMI cable. Therefore, it has an output destination control means. Like D1, the Wii U console also supports multiplayer games. According to the Nintendo customer support, Minecraft on the Wii U (released December 2015, thus at least a month before the relevant date of the present application) has a multiplayer split screen mode which is only supported for a [larger] HDMI external screen connected by a HDMI cable. Whist [sic] the Board realises that the above customer support information is not prior art, the Board has no reason to doubt that the Wii U playing a minecraft game would have been the same at the relevant date. " (square brackets added in the decision).
• "The subject-matter of claim 1 differs from D4 in that, when the restriction is in place, that is when the game is played on the display means rather than the TV, multiplayer play is not performed by players exceeding a predetermined number of players. Because this claim feature is concerned with multiplayer play, it is implicit that the predetermined number of players is more than one (cf. D4's restriction to a single Minecraft player). For example, according to the invention it could be two players in accordance with the number of [two] operation devices (cf. published application, paragraph [0026])."
• Hence, compared to D4, no longer only single player mode is available on the Wii U game pad, but also a limited multiplayer mode.
• The Board considers the feature to be not inventive.
• "the idea of restricting the number of players permitted to play a certain game according to the screen used (display or TV) determines how gameplay is permitted to develop and thus lies firmly in the domain of the game designer who conceives the game. The game designer will make this choice based, amongst other things on the screen area and screen resolution needed for a player to comfortably view the content of a particular game. Moreover, the players will be well aware of the game designer's choice in this respect: They would know that using a certain screen determines how many players can play the game. Thus the Board considers that a game rule underpins this feature."
• "the Board adopts the approach as set out in T 1543/06 (Gameaccount) which is based foremost on T 0641/00 (Comvik, OJ EPO 2003, 352). Thus, only those features that contribute to technical character are to be taken into account when assessing inventive step. That requirement cannot rely on excluded (non-technical) subject-matter alone, however original it may be. The mere technical implementation of something excluded [under Art. 52(2), i.e. a game rule] cannot therefore form the basis for inventive step. Rather, it is necessary to consider in detail how that matter has been technically implemented."
• 
  

EPO 

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

T 2020/20 - Change of ED composition between OP and decision taken in writing

Key points

•  "At the end of the oral proceedings, the examining division informed the appellant that it could expect a communication pursuant to Rule 71(3) EPC on the basis of auxiliary request 2, provided that a clean copy of the application documents was filed."
• "On 21 August 2019, the examining division issued a third communication pursuant to Rule 71(3) EPC expressing its intention to grant a European patent based on auxiliary request 2. In an annex, the examining division set out the reasons why it had admitted the third-party observations and why it considered the claims of the main request and auxiliary request 1 to be unclear and thus not allowable."
• " By letter dated 20 December 2019, the appellant indicated that it did not approve the text proposed for grant in the third communication pursuant to Rule 71(3) EPC. It requested a decision which could be appealed if the examining division was not able to grant a patent based on either the main request or auxiliary request 1."'
• "On 25 June 2020, the examining division issued the decision under appeal. The reasoning given for the admittance of the third-party observations and the non-allowability of the main request and auxiliary request 1 is an almost verbatim copy of the reasoning annexed to the third communication pursuant to Rule 71(3) EPC. Compared to the composition of the examining division which had conducted the oral proceedings and which had issued the third communication pursuant to Rule 71(3) EPC, the composition of the examining division which signed the decision under appeal was changed: the first examiner was no longer part of the division, the previous chairman had become the first examiner and a new chairman had been appointed."
• "It is established case law that a signed written decision issued after oral proceedings should be taken by the same members of the first-instance division who conducted the oral proceedings. If a change in the composition of the division occurs after oral proceedings, parties should therefore be offered new oral proceedings."
• "According to Article 18 EPC, oral proceedings should be held before the examining division itself. The right under Article 116(1) EPC to have oral proceedings can therefore only mean a right to have oral proceedings before the examining division in a composition which also takes the final decision on the case. If the division conducting the oral proceedings could be different from that taking the final decision, oral proceedings would be deprived of its purpose and Article 116(1) EPC would be meaningless."
• The decision is set aside, and the appeal fee is reimbursed.
• Compare T 0229/18, where the Chair of the Board retired between the oral proceeding and the issuing of the written decision. These two decisions may not be inconsistent with each other, but it is a rather delicate balance. 

EPO 

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

T 1625/21 - Shuffling auxiliary requests in appeal

Key points

• Some auxiliary requests were admissibly filed before the OD and were substantiated in the proprietor's statement of grounds. The OD had maintained the patent in amended form. Can the Board hold these auxiliary requests inadmissible? 
• If yes, on what ground?
• The answer is that the requests were renumbered in appeal, from Auxiliary Requests 8-9 before the OD to requests 3-4 in appeal. I understand that AR-1 before the OD was filed during the oral proceedings before the OD (see the minutes), was held allowable by the OD, and was narrower than AR's 8 and 9.  
• The Board, in German: " Diese Anträge sind aus im Wesentlichen den gleichen Gründen nicht zulässig, da sie auf den erstinstanzlichen Hilfsanträgen 8-9 (in der mündlichen Verhandlung umnummeriert zu Hilfsantrag 9 bzw. 10) beruhen, die die Patentinhaberin zugunsten des damaligen Hilfsantrags 1 der Einspruchsabteilung nicht zur Entscheidung vorgelegt hat. Auch diese Anträge versuchen die Einschränkung auf w-Wert zwischen 20 und 40 (Hilfsantrag 5) bzw. auf die Verwendung des nichtionische Tensids (Hilfsantrag 3 und 4) rückgängig zu machen bzw. durch andere Einschränkungen zu ersetzten. Einsprechende Anträge hätten jedoch bereits erstinstanzlich eingereicht werden können und sollen (Artikel 12(4) und (6) VOBK)." 

EPO 

The link to the decision is provided after the jump.

T 0600/21 - Admissibility, complexity, and matters the OD did not arrive at

Key points

• The Board decides not to admit AR-3 in this opposition appeal.
• The proprietor filed these requests in their reply to the appeal of the opponent. The Board in machine translation notes that: "it did not explain which objections the respective changes address and why the changes are suitable for overcoming the objections raised against the main application. Without this information, the requirement of Article 12(3) RPBA that the response to the complaint must contain the respondent's complete complaint is not fulfilled, unless the changes are self-explanatory in this respect. However, this is not the case." 
• The amendment is limiting the claimed detergent composition to a solid detergent composition.
• The Board: "solid dishwashing detergents are undisputedly part of the state of the art, so it is not self-explanatory why the inclusion of this feature eliminates the objection of lack of inventive step." (the higher ranking request was rejected as obvious over D12).
• The Board, however, also acknowledges that D12 is about liquid detergents, not about solid detergents. The Board does not explain why it is not self-evident that an amendment that changes the closest prior art is not a suitable amendment in reply to an inventive step attack.
• The Board notes that if these auxiliary requests are admitted, then D25 filed by the opponent also has to be admitted, and inventive step starting from D25 has to be discussed. This would run against procedural economy and would be a further reason for not admitting the auxiliary request under Article 12(4) RPBA.
• The Board does not indicate that the amended claim would be obvious starting from D12. In fact, the need to consider inventive step starting from D25 speaks against this, it seems to me.
• The Board does not indicate that the amended claims should have been submitted in the first instance proceedings under Art. 12(6).
• The Board does  not (or at least not explicitly) acknowledge that Art. 12(4) fifth sentence, mandates the consideration of all three of the following factors: "The Board shall exercise its discretion in view of, inter alia, (i) the complexity of the amendment, (ii) the suitability of the amendment to address the issues which led to the decision under appeal, (ii) and the need for procedural economy." (emphasis and numerals added).
• The Board does not consider, or at least not explicitly, factor (ii), which is the only factor in the list that is by its nature in favour of admitting any amendment (i.e. a high score on factor (ii) is a reason for admitting the amendment, a high score of factors (i) and (iii) is a reason for not admitting the amendment).
• The analysis that the responsive filing of D25 by the opponent can be considered under the factor complexity (factor i) seems in line with Müller and Mulder's Proceedings before the European Patent Office, 2^nd ed., 2020, p.125.  
• The OD found the set of claims inventive over D12. So, the OD would not have arrived at the amended set of claims even if AR-3 had been filed before the OD, and the Board would have no reasoning by the OD to review, it seems to me. The filing of AR-3 at the beginning of the appeal, in that sense, does not add procedural complexity, compared to the case where it would have been filed before the OD. Moreover, the OD would have no reason to consider inventive step over D25 for a request that it would not have arrived at had the request been pending in the first instance proceedings (at least the OD would not have to include any reasoning on that point in the decision because the OD considered a higher-ranking request to be allowable). So, introducing D25 in appeal does not seem to increase complexity. 
• As I understand it, AR-3 was the highest-ranking request after the set of claims held allowable by the OD. 
• The application was filed in 2005 as a PCT application and granted in 2018.

• EPO 

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

T 1656/17 - Dealing with a partiality objection

Key points

• This decision was issued in October 2023 after a five-year appeal procedure (but with a separate decision on a partiality objection). The grant was in 2014. The PCT filing date is in 2008. A petition for review is pending.
• The first oral proceedings took place on 5 July 2022. The Board concluded that claim 1 was obvious over D10. The oral proceedings were adjourned to 14 July 2022, as vico, with the consent of the parties.  The appellant/proprietor withdrew his consent on 8 July. Oral proceedings were resumed on 21 October 2022 after a new summons. 
• The Board refused to reopen the debate, giving rise to a first objection under Rule 106.
• Two further objections were raised under Rule 106.
• " The oral proceedings were interrupted at 17.49 hrs for deliberation by the board on the admittance of documents D38a, D46, D47 and D48.
• " At 18.20 hrs, one of the respondent's representatives entered the room where the board was deliberating and closed the door behind him ("the room incident"). He asked about the timetable of the oral proceedings on that day as the respondent's representatives had to catch a plane to London. The chair immediately asked him to leave the room as the board was deliberating, adding that the parties would be called in in a few minutes. The representative immediately left the room at 18.21 hrs." 

• A new objection under Rule 106 was filed by the proprietor.

• " On 27 October 2022, the board issued summons to in-person oral proceedings, according to which the oral proceedings were to be resumed on 11 January 2023."  These summons were for three days.

• " By letter dated 28 December 2022, the appellant raised objections of suspected partiality under Article 24(3) EPC against the members of the board." 

• " On 11 January 2023, at 14.05 hrs, the oral proceedings before the board in its original composition were interrupted and an alternate board was appointed. After the alternate board decided [on 12 January, with oral proceedings before the alternate Board on 11 and 12 January] that the objection of suspected partiality against the members of the board in its original composition be refused, the oral proceedings before the board in its original composition were resumed on 13 January 2023, at 9.02 hrs. 

• " At 09.04 hrs, shortly after the resumption of the oral proceedings before the board in its original composition on 13 January 2023, the appellant filed the following objection under Rule 106 EPC" 

• " At 16.53 hrs, the appellant filed a further objection under Rule 106 EPC ("objection 6"), which reads as follows: ..." 

• The Board, on 13 January 2023, dismissed the appeal.

• The Board issued the decision, 173 pages in writing, in October.

• 
  
• EPO 

The link to the decision is provided after the jump.

T 2175/15 - The opponent submits five partiality objections

Key points

• Three interlocutory decisions on partiality were issued in September 2023 in this opposition appeal case, where the opponent has, up to now, filed five partiality objections. 
• The decisions are anonymised, but the application number is easy to find and the file is public (some letters are redacted). 
• The appeal was filed in November 2015, the statement of grounds was in January 2016, and the reply was filed in May 2016, followed by the silence of the Board until April 2019: summons for oral proceedings to be held on 20 March 2020 (bad luck). 
• Oral proceedings were postponed and finally held by vico in January 2021. The Board admits auxiliary requests and decides that the proceedings continue in writing.
• The opponent, represented by a professional representative of a German firm, files a first partiality objection in April 2021, followed by a second one when the Board, in original composition, outlines the framework for admissibility. The second objection is rejected by the Board in alternate composition.  The Board, in the original composition, issues a new summons with a preliminary opinion on the remaining issues of the admissibility first partiality objection and the apportionment of costs (the patentee had withdrawn the appeal). The opponent files a third partiality objection. Again, a Board in alternate is then formed, and the opponent files a fourth partiality objection against one of the members of the Board in alternate composition. A replacement Board member was appointed, and the opponent filed a fifth partiality objection. A further replacement member is appointed. Oral proceedings are held in June 2023 before the Board in alternate composition.
• The second objection was dismissed in  April 2022, and now the 3rd, 4th and 5th. 
• The decision on third objection was taken by Board members N, D, H; the decision on the fourth objection by K, D and H, the decision on the fifth objection by G, D and H, all on the same day. Must have been an interesting set of oral proceedings on 23 June 2023. However, the minutes are not visible in the online file.
• The register shows that a petition for review R 16/22 is pending against the decision of April 2022, though the documents about that petition are not visible in the online file. 
• The appeals were withdrawn on 4 and 7 July 2022 but the opponent maintained its request for cost apportionment. 
• There was some litigation about the national German patent. I understand that there was some German  case law that a preliminary injunction could not be awarded by German courts until the validity of the patent was proven in opposition (or nullity) proceedings (see CJEU case C-44/21 of April 2022). So, possibly, the opponent had no clear interest in a swift end to the opposition proceedings at the relevant times.

EPO 

The link to the decision is provided after the jump.