T 0983/20 - Admissibility and admissibility

Key points

• This post is kind of at the EQE level, but still illustrative.
• The OD rejected the opposition. The opponent appeals.
• "In the contested decision, the opposition division considered the solution proposed by claim 1 as granted to involve an inventive step. In section 2.2 of the reasons for the decision the opposition division addressed the opponent's objection of obviousness based on a combination of D1 and  D2. The opposition division summarised the opponent's arguments and set out two reasons why they were not found convincing".
• " In the statement of grounds of appeal the appellant (opponent) requested that the decision under appeal be set aside and that the patent be revoked in its entirety. They submitted that the subject-matter of all of the claims 1 to 7 of the patent lacked an inventive step over a combination of D1 and D2."
• "With further submissions filed after the statement of grounds of appeal, the appellant presented further arguments regarding the objection of lack of inventive step over documents D1 and D2. The appellant also presented a new objection of lack of novelty under Article 54(3) EPC over [D3, ] a European patent application which had not previously been cited."
• The Board considers the appeal to be inadmissible under R.99(2). 
•  "the Board concurs with the respondents that the statement of grounds of appeal does not address the reasons given in the contested decision as to why the subject-matter of claim 1 is not rendered obvious by the combination of document D1 and document D2."
• "The statement of grounds of appeal to a large extent merely repeats the submissions that were made in the letter of 10 October 2019 prior to the oral proceedings before the opposition division. The statement of grounds of appeal does not address or deal with the reasons set out in the penultimate paragraph of section 2.2 of the reasons for the decision and does not enable the board to understand immediately why they should be incorrect."
• The appeal is rejected as inadmissible.
• The Board does not arrive at the new attacks based on D3. 
• The decision illustrates that admissibility under Rule 99(2) is not a discretionary decision and is "all or nothing". Admissibility under Rule 99(2) and under Art. 12, RPBA should not be conflated. 
• 
  

EPO 

The link to the decision is provided after the jump. 

T 1252/20 - A solution for forming a blockage in a blood vessel

Key points

• Claim 1 is directed to " A composition for use in reducing ... cancerous cells in a subject by forming at least a partial blockage, ... in a blood vessel to deprive a tumor in the subject of blood supply, ...  the composition comprising: a solution comprising an amphiphilic peptide in an effective amount and in an effective concentration to form a hydrogel under physiological conditions to allow at least a partial blockage of the biological vessel to effect embolization or cell necrosis therein, ..."
• The question is whether this is a valid second medical use claim. 
• " In its decision the Examining Division came to the conclusion that the peptide solutions defined in claim 1 of the applicant's main request did not qualify as "substance or composition" in the sense of Article 54(5) EPC, their mode of action being purely mechanical. The Examining Division referred in particular to decision T 1758/15 to support this view. " 
• " The Board, however, is convinced that the peptide solutions defined in the claim do qualify as "substance or composition" in the sense of Article 54(5) EPC, and that thus the claimed subject-matter is novel over D1 and D2 due to the specific use defined therein. This will be reasoned in the following." 
• "  The question of what can be considered a "substance or composition" in the sense of Articles 54(4) and (5) EPC regularly emerges in cases before the Boards of Appeal. From the analysis of Articles 53(c) and 54(4) and (5) EPC as explained above it follows that not every object can be read on this definition, although of course every object, also a medical device, is in the end made up of substances and/or compositions. The decision G 5/83 which established the patentability of second medical indications and in fact served as the basis for Article 54(5) EPC (see T 1758/15, Reasons 5.2.5) also emphasised that the application of the special approach to novelty through the intended use is strictly limited to claims that are directed at substances or compositions intended for use in methods stipulated by Article 52(4) EPC 1973, corresponding to Article 53(c) EPC (G 5/83, Reasons 21, last sentence)." 
• " [Established] case law imposes restrictions to what may fall under the definition of "substance or composition" in the sense of Article 54(5) EPC based on its mode of action. Whereas the materials underlying these cases, collagen fillers, alginates or bone glue, would, in everyday language, be seen as substances or compositions, they were not considered "substances or compositions" in the sense of Article 54(5) EPC since once inside the body they acted as a device." 
• " [The Board] is convinced that the peptide solutions defined in the claim must be considered a "substance or composition" in the sense of Article 54(5) EPC already for more fundamental reasons. In the following, for reasons of brevity, also where only "substance" is mentioned, it is understood that a "substance or composition" within the meaning of Article 54(5) EPC is meant."
• I recommend reading the entire decision.  
• " the exceptional approach to novelty of Article 54(5) EPC (and equally of Article 54(4) EPC) is not only applicable in case of therapeutic treatments, but also for treatments by surgery and for diagnostic methods. Decision G 5/83 addresses exclusively a therapy where a medicament is administered and its active agent achieves some therapeutic effect, such as treating an illness. The claim category endorsed by G 5/83 was also explicitly directed at the "use for manufacture of a medicament". However, with the adoption of the EPC 2000 it became clear that the novelty exception now generally encompassed all uses of a substance falling under Article 53(c) EPC, e. g. also surgical treatments and diagnostic methods, meaning that the the scope of Article 54(5) EPC is broader (G 2/08, Reasons 6.5). This already speaks against a too narrow interpretation of "substance or composition", possibly limiting it to such uses where the mode of action is exclusively or at least predominantly chemical. In particular, the use of a substance in a surgical or diagnostic method may possibly involve various mechanisms of action which may not immediately appear comparable to a classical "chemical" reaction triggered by a medicament." 
• " There is no legal basis for the mode of action as a criterion for qualifying a material or object as a substance or composition under Article 54(5) EPC. " 
• " In addition to the lack of a legal basis, the use of the mode of action as the decisive criterion seems problematic for several other reasons. First of all, the material acting inside the body may not be the same than the material the claim is directed to. The material defined in the claim and the material acting inside the body may differ in composition or in some other relevant property. This is clearly so in the present case. The claim requires the presence of a peptide solution. Already for this reason the claim is not directed to any particulate or spheric form of a hydrogel formed from the peptide solution inside the body. The question to be asked is whether the peptide solution defined in the claim is a "substance or composition". This question is to be decided irrespective of whether any solidified macrostructure formed from the substance, upon application in a specific way, can also be considered a substance or composition, or should rather be seen as a device. In other cases even the chemical structure of the substance may not remain the same during the therapeutic use. The Board notes that there are classical drugs which are administered as inactive prodrugs, the active species only being formed in the body by metabolic processes. However, second medical use claims under Article 54(4) and (5) EPC are generally directed to the administered substance. Since it is this substance which is used in a method excluded under Article 53(c) EPC, such a claim drafting is entirely in line with Articles 54(4) and (5) EPC."
• "The Board does not overlook the fact that distinguishing devices from substances for the purposes of Article 54(5) EPC is indeed required, and this article should not be used to circumvent the usual assessment of novelty of devices. A pacemaker or a surgical scalpel made of a particular stainless steel alloy do not qualify as a "substance or composition", even if they are claimed for use in an arguably novel therapeutic or surgical method. However, there is no apparent reason to disqualify a solution of a peptide, i. e. a shapeless liquid defined without any device-like features, from the scope of Article 54(5) EPC."

EPO 

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

T 0956/21 - Is one way of preparing a product enough?

Key points

• Claim 1 is directed to a "Coated cutting tool comprising a substrate coated with a coating". The coating has some properties, in particular a specific texture.
• "the skilled person has to know how to choose the appropriate deposition conditions to obtain a cutting tool insert comprising an alpha-Al2O3 layer and a MTCVD TiCN layer as required by claim 1."
• "The examples of the patent describe a very detailed manufacturing method. However, this exemplified method encompasses a lot of process steps and settings (such as a "CO ramp") relating to the production of non-claimed details (such as a bonding layer), these process steps being non-essential in regard to the manufacture of a cutting tool insert according to claim 1 but still having have an influence on the texture as argued by the appellant"
•  "The experimental data presented in Table 2 of D7 raised serious doubts as to whether the skilled person could rework the invention over the whole scope of protection based on the general disclosure of the patent specification while taking into account the examples of the patent."
•  "The appellant [proprietor] accordingly argues that the skilled person could obtain coated tool inserts according to claim 1 by following the specific examples of the patent, since the examples would appear to describe a detailed manufacturing process."
• "In the present case, the appellant's arguments with regard to the experiments in D7 and D50 confirm that any minor deviation from the very detailed and very specific method described in the examples of the patent may be expected to result in failure to obtain the required texture of the alpha-Al2O3 layer even if these specific method steps relate to the manufacture of a non-essential bonding layer which is not required according to claim 1."
• "the patent does not provide any teaching which might guide the skilled person to obtain coated cutting tool inserts according to claim 1 in the event of deviation from the very specific exemplary manufacturing method described in the example."
• As a comment, according to T 595/95, "A product which can be envisaged as such with all the characteristics determining its identity including its properties in use, i.e. an otherwise obvious entity, may become non-obvious and claimable as such, if there is no known way or applicable (analogy) method in the art to make it and the claimed methods for its preparation are the first to achieve this and do so in an inventive manner". Under T 595/95, providing one way of preparing the desirable product is (as far as I know) regularly considered to be sufficient to support a product claim. 

EPO 

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

T 0614/21 - Could have presented in first instance proceedings (?)

Key points

• The OD maintained the patent as granted.
• The Board finds the claims as granted to be not new.
• The auxiliary requests were filed with the Statement of grounds and were substantiated.
• The Board does not admit them.
• "The board notes that the novelty analysis of claim 1 of the main request already required  a discussion during the oral proceedings before the board on how to interpret - the verb "to accept" in accordance with feature (d) and - the expressions "on behalf of" and "whilst identifying as" according to features (e) and (g). The amendments underlying claim 1 of auxiliary requests 1 to 7 would further necessitate an interpretation of several new expressions for the first time. The board refers in particular to - the expressions like "intercept", "masquerade" and "terminates" as per features (i), (k) and (l), or, similarly, "intercepting", "masquerading" and "terminating" as per features (j) and (m) and to - the term "believes" in accordance with features (l) and (m)."
• As a comment, it seems to me that any added feature may involve new expressions and hence claim interpretation. I do not see how a need for claim interpretation could be a reason for holding the amended claims inadmissible, in particular if there are no clarity objections.
• I am also not sure if the Board here is perhaps holding the fact that the proprietor made use of its right under Article 116 EPC to defend the main request in oral proceedings against the proprietor.
• "It is also worth noting that the appellant [opponent] indicated already in its statement setting out the grounds of appeal that the term "masquerading" did not have "a well recognised meaning in the field". It raised an objection as to insufficiency of disclosure under Article 100(b) in combination with Article 83 EPC in this respect. The board therefore considers that admitting auxiliary requests 1 to 7 into the proceedings would be detrimental to procedural economy."
• The Board does not indicate if the opponent's objections made sense prima facie. The mere fact that the opponent had objections is stated as ground.
• The patent is revoked.
• The Board does not explicitly consider the two other factors of Art. 12(4) besides procedural economy. 
• The issues about new allegations under Art. 83 seem to pertain to Art. 13(1)(s.4) (and, for completeness' sake,  the phrase "does not give rise to new objections" in Art. 13(1) logically means (in my opinion) (prima facie) valid objections, not the mere fact that an opponent comes up with some allegations.

• The Board, "The respondent [proprietor] explained that there was no need to file any auxiliary requests during the opposition proceedings because the opposition division rejected the opposition. The board, however, considers that a party prevailing in opposition proceedings is not relieved from its duty to timely prepare its case for the event of subsequent appeal proceedings. Indeed, each party should take into account that either the opposition division or the board of appeal may depart from the preliminary view expressed by the opposition division and adopt an opposing view. The patent proprietor should prepare the relevant "fallback positions" for that eventuality. There is however no right to present on appeal "fallback positions" that could have been presented already in the first-instance proceedings. Anything else would be contrary to the primary purpose of the appeal proceedings as laid down in Article 12(2) RPBA 2020, i.e. the judicial review of the decision under appeal."
• As a comment, the Board does not invoke Article 12(6) RPBA. The status of the remark is, therefore, unclear to me.  Moreover, the Board uses "could" have been presented already in the first-instance proceedings" but Article 12(6) uses "should". 
• As a further comment, the filing of the auxiliary requests already before the OD would not have assisted the Board with the judicial review because the OD would not have decided on them.

 

EPO 

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

T 0762/20 - Is email a valid means of communication?

Key points

•  "point 9 of the contested decision states the following:

  "An email was sent to the applicant on 08-10-2019, in which the first examiner communicated the feature mapping of the inventive step objection under Article 56 EPC. The Article 56 EPC objection was based on document D5 (XP010914819, 'Towards Protecting Sensitive Files in a Compromised System') a further document found by the examining division which appeared to be a closer prior art document than D4."

• "However, the electronic file, which is the sole official file relating to the European patent application (Rule 147(1) EPC) and the record of the first-instance proceedings available for file inspection and used by the board in its judicial review, does not contain the email sent to the appellant on 8 October 2019."

•  "it seems that the email apparently sent on 8 October 2019 was the only occasion on which the examining division may have commented on document D5 and could have given a clear indication that this document would be relevant for the assessment of inventive step before issuing the written decision. The board thus agrees with the appellant's objections (see point IV. above) to the extent that the appellant was not officially informed of an inventive-step objection based on document D5 by the EPO before the notification of the contested decision. Moreover, in the circumstances of the current case, the missing email is the essential piece of evidence for reviewing whether the appellant's right to be heard under Article 113(1) EPC was respected. Since this email is not available to the board, the board cannot review the contested decision in a judicial manner (Article 12(2) RPBA 2020). "

• I wonder whether, had the email been available in the electronic file, it would have counted as a valid means of communication to safeguard the applicant's right to be heard.  Possible the present decision should not be interpreted in this way because the Board was addressing only the case at hand where it was not available in the file.

EPO 

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

T 0602/21- Admitting a request cancelling independent claims

Key points

• "It is further noted that in the present case, the main request allowed by the opposition division contained several independent claims, namely claims 1, 2, 3, 4, 5, 6, 9 and 10. Under these circumstances, it would have been the duty of the appellant [opponent] to duly substantiate already in their statement of grounds of appeal why they considered that the decision of the opposition division was wrong that each of these independent claims met the requirements of the EPC. In that regard, admitting the appellant's objections of lack of inventive step raised against claims 1, 2 and 4 of auxiliary request 3 (which correspond to claims 1, 2 and 6 of the main request) would go against the stipulations of Article 12(3) RPBA that the appellant should present their complete case in the statement of grounds of appeal."
• The Board admits the auxiliary request limiting to three of the independent claims that was filed after the notification of the summons, i.e. under Art. 13(2) and does not admit the inventive step attacks presented in reply to it during the oral proceedings.
• The Board finds the auxiliary request to be allowable. 

EPO 

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

T 1324/21 - Spontaneously forming polymorphs

Key points

• From Derk Lowe's weblog: "The classic story is ritonavir, the anti-HIV medication (now used as a CYP metabolism inhibitor in Paxlovid and other formulations). Eighteen months after FDA approval and the arrival of the drug on the market, a more stable and less soluble polymorph began to take over the world, first noticed as a higher dissolution-test failure rate on the manufacturing line. This extremely unwelcome development precipitated a crisis (couldn’t resist the wording) which was only solved by a great deal of experimentation under severe time pressure, and the whole affair greatly impacted severely ill patients while costing Abbott hundreds of millions of dollars." (https://www.science.org/content/blog-post/stalking-polymorphs) 
• See here for a further review, also discussing patent litigation on polymorphs: https://onlinelibrary.wiley.com/doi/full/10.1002/anie.201410356
• Turning to the present case, claim 1 is directed to a pharmaceutical composition comprising rifaximin in polymorphic form alpha and in polymorphic form delta, and comprising 10 wt% to 45 wt% filler.
• The OD found the claim to be novel, as follows: " Xifaxan tablets of batch 13012, which according to document D9 were purchased before the priority date, had been shown in document D7 to comprise the polymorph forms alpha and delta of rifaximin in the ratio and total amount as defined in claim 1 of the main request. However, it had not been demonstrated that these Xifaxan tablets could be analysed to comprise a relevant amount of filler." 
•  The proprietor argued as follows for inventive step: " The Xifaxan tablets of batch 13012 comprised in addition to rifaximin form alpha also rifaximin form delta. The presence of rifaximin form delta was contrary to the official documentation on the Xifaxan tablets, in particular document D15, according to which only rifaximin form alpha was used for the preparation of the tablets, which would not convert to other forms during manufacture or storage. Document D15 actually recommended to ensure that the commercial preparation of rifaximin is the poorly absorbed polymorphic form alpha in view of the greater oral bioavailability of other polymorphic forms. The Xifaxan tablets of batch 13012 were therefore defective and unsuitable as starting point for the assessment of inventive step." 
• The Board, on novelty: " The declaration in document D44 reports that Xifaxan 550 mg tablets as available on the market before the priority date of the patent had been prepared using the filler MCC with a water content of 3.2% in an amount which corresponded to 29.9 wt% of filler in the tablets [] Document D44 therefore indicates that the Xifaxan tablets of batch 13012 did indeed comprise an amount of filler as defined in claim 1 of the main request." 
• " The experimental report in document A55 demonstrates that the amount of filler in Xifaxan tablets of batch 13012 could be analysed using methods as described in documents A56 and A57, which were available at the relevant time. Document A55 confirms that using these methods the Xifaxan tablets of batch 13012 were found to comprise a MCC content of 28.2-29.0% on the basis of dry MCC " 
• " Accordingly, the Board concludes that the subject-matter of claim 1 of the main request lacks novelty." 
• Auxiliary Request 1 is limited to a method of preparing a tablet comprising " providing (A) rifaximin in polymorphic form alpha and (D) rifaximin in polymorphic form delta"  and compressing.
• The question is whether the public prior use is a suitable starting point for inventive step. " Whilst the originally contained rifaximin form alpha in the Xifaxan tablets of batch 13012 had thus according to document D7 apparently partially [and spontaneously, during storage] converted to form delta by 17 December 2015, these tablets had at that time not yet expired. "
  
• " Contrary to the finding in the decision under appeal the Board considers that this approved market product, which had not expired, cannot be disqualified as a realistic starting point for the assessment of inventive step with respect to the method for preparing tablets comprising corresponding amounts of rifaximin form alpha and delta as defined in claim 1 of auxiliary request 1." 
• " the Board concludes that the subject-matter of claim 1 of the auxiliary request lacks an inventive step." 
• The patent is revoked.
• EPO 

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

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."
• 
  

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.