27 March 2024

T 1879/21 - For inducing smoltification

Key points

  • Claim 1 is directed to "A fish feed for inducing smoltification of Salmonidae"
  • "The patent is concerned with the provision of fish feed that induces smoltification of Salmonidae. This family of fish includes Atlantic salmon and rainbow trout. Salmonids in freshwater which decide to migrate to seawater undergo a physiological process called smoltification. Smolt refers to a salmon fish in freshwater ready for migration to seawater"
  • "To meet the requirements of sufficiency of disclosure, an invention has to be disclosed in a manner sufficiently clear and complete for it to be carried out by the skilled person without undue burden and without needing inventive skill on the basis of the information provided in the patent specification and, possibly, common general knowledge."
  • "Claims 1 and 6 comprise the functional feature "for inducing smoltification of Salmonidae" or "for inducing smoltification in Salmonidae", respectively. In accordance with G 1/03 (Reasons 2.5.2), if an effect forms part of the claimed subject-matter and there is lack of reproducibility of the effect, there is lack of sufficiency of disclosure. For the reasons set out below, the board concludes that the specification does not contain sufficient information on relevant criteria for finding appropriate alternatives over the whole scope of the claims with reasonable effort."
    • I wonder if in claim 1, "for inducing smoltification" is limiting or is, in effect, "suitable for" ? Is it a second medical use claim ? Or can a feature simultaneously be "functional" for Art. 83 and "suitable for" for Art. 54 ?
    • Note, claim 6 as granted is directed to "Use of a fish feed  ...  for inducing smoltification in Salmonidae" which could be a method of treatment claim, if claim 1 is a second medical use claim. 
  • ", the board notes that the statements in declaration D31 from an expert [of the proprietor] and in D66 by the inventor support the view that the relative concentrations of activators/positive modulators and deactivators/negative modulators of PVCRs need to be adjusted (or "tailored") to obtain a non-haphazard and reproducible activation and smoltification."
    • "these statements in D66 were made in a dispute over inventorship and remuneration under Norwegian law"
  • " The board thus agrees with the opponents that the knowledge to carry out the claimed invention is not shared with the public via the patent. By contrast, the statements in D31 and D66 undermine the patent proprietor's assertion that the broad ranges for the positive and negative PVCR modulators provided in the claims were already "tailored" (or optimised) and that thus any ratio of the modulators could be combined to induce smoltification."
  • "Given these considerations and the serious doubts substantiated by verifiable facts, the single example feed of the patent does not have sufficient probative value to show that the invention is operable across the entire scope claimed. Although that feed composition (test diet 2) is in line with the invention as claimed, by itself it is insufficient given that the metal ion content is not specified and the amounts of activator species far exceed the minimum amounts required in claim 1. "
  • The patent is revoked.
EPO 
The link to the decision is provided after the jump, as well as (an extract of) the decision text.


25 March 2024

T 0498/22 - Late filed late-filed objection

Key points

  • The Board, in translation: " The appellant argued for the first time in the oral hearing that auxiliary request 1 should have already been submitted in the first instance [and was therefore inadmissible]." 
  • The Board: " First of all, it should be noted that, according to Article 13(2) RPBA 2020, such a request for non-admission, which was only submitted during the oral hearing, is generally not to be taken into account. The response to the appeal with the auxiliary requests was submitted in August 2022. The summons to the oral hearing with the chamber's preliminary opinion was made in July 2023, so that the appellant had sufficient time to respond to the response to the appeal before the summons. Nor were any exceptional circumstances claimed under Article 13(2) RPBA 2020." 
EPO 
The link to the decision is provided after the jump, as well as (an extract of) the decision text.


22 March 2024

T 1660/22 - Disclosed disclaimer, and lacking rejoinder

Key points

  • The OD found the claims as granted to be allowable.  The opponent appeals. The Board arrives at AR-5, filed before the OD and resubmitted by the patentee/respondent in their reply to the appeal.
  • AR-5 specifies the absence of a catalyst in the claimed process.
  • " The subject-matter of claim 1 contains a (disclosed) disclaimer. The question to be assessed is whether the remaining claimed subject-matter was directly and unambiguously disclosed in the application as filed (G 2/10 ...)" 
  • " The original disclosure also contained the method for producing HFSI without a catalyst, as is apparent from the published original application (A1). A1, paragraphs [0024], [0025], [0028] and [0032] disclose that a catalyst is optional. Paragraph [0031] even discloses that the reaction does not require a catalyst to give acceptable results. Example 2, carried out without a catalyst and showing a yield of 98%, supports this statement. Therefore, the remaining subject-matter, i.e. the method for producing HFSI at a high yield by reacting HXSI with HF under reflux conditions to remove HX, in the absence of a catalyst, is directly and unambiguously derivable from the application as originally filed." 
  • Turning to the admissibility of the inventive step objections, " In the statement of grounds of appeal, the appellant merely attacked the dependent claims of the main request. The disclaimer contained in claim 1 of auxiliary request 5 was, however, not contained therein. Moreover, the appellant did not submit arguments against the auxiliary requests as filed during the opposition proceedings and as resubmitted with the reply to the appeal. The appellant's submissions in particular did not address an embodiment without a catalyst. Only during the oral proceedings before the board did the appellant argue against the inventive step of claim 1 of auxiliary request 5." 
  • The Board's reasoning is not unambiguous but is consistent with the view that the opponent was not required to comment on AR-5 in the statement of grounds (as the OD did not reach AR-5 in their decision) but should have filed a rejoinder when AR-5 was resubmitted in appeal.

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

20 March 2024

T 1416/21 - Reworking the example from 1956

Key points

  • The claim at issue is a product claim directed to " "Crystalline 2'-O-fucosyllactose polymorph II" (having certain XRD peaks) . The compound 2'-O-fucosyllactose  "was first discovered in the 1950s in human milk" (wiki)
  • D1 is Kuhn, R. et al., Chem. Ber. 1956, page 2513
  • The opponent/respondent: "  Method 2 of D1 represented an enabling disclosure. Experiment 1 of D21 was a proper repeat of method 2 of D1, i.e. a repeat which the skilled person would have carried out having their common general knowledge in mind. The product of experiment 1 of D21 showed the XRPD peaks provided for in claim 1 of the main request and auxiliary requests 1 to 9. "
  • " The board agrees with the respondent that experiment 1 of D21 is a proper repeat of method 2 of D1, i.e. a repeat which the skilled person would have carried out having their common general knowledge in mind. In particular, in both method 2 of D1 and experiment 1 of D21, amorphous 2'-FL is dissolved in a certain volume of aqueous methanol and the solution is diluted with the same volume of n-butanol. Afterwards, a few drops of n-hexanol are added and crystallisation is carried out at 4 °C."
  • Claim 1 is found to be not novel.

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



2. The respondent put forward a novelty objection to the subject-matter of claim 1 based on D1.

3. D1 addresses the problem of providing crystalline 2'-FL. It states (lines 1 to 6) that purification of 2'-FL by repeated chromatography or via its tosylhydrazone does not immediately yield crystalline 2'-FL. Rather, a syrup or, after treatment with alcohol, an amorphous white powder is obtained first.

3.1 According to D1 (lines 6 to 10), crystalline 2'-FL can be obtained from the above-mentioned syrupy 2'-FL as follows (denoted as "method 1" by the parties):

"Nach längerem Aufbewahren von 2.1 g eines mit Wasser abgedampften Sirups bei ~20° schieden sich am oberen Teil der Kolbenwand einige weiße Kriställchen ab, mit deren Hilfe sich der gesamte Sirup über Nacht in ein lockeres Kristallpulver verwandeln ließ."

[translation by the board: After storing 2.1 g of a water-evaporated syrup for an extended period of time at approximately 20°, some white crystals separated at the upper part of the wall of the flask, with the help of which the entire syrup could be transformed into a loose crystalline powder overnight.]

3.2 D1 further discloses (lines 10 to 17) that, starting from amorphous 2'-FL, crystalline 2'-FL can be obtained as follows (denoted as "method 2" by the parties):

"Ein anderer Ansatz, in dem nach mehrwöchigem Aufbewahren bei +4° spontan Kristallisation eintrat, war durch Lösen von amorphem Trisaccharid in wasserhaltigem Methanol und Zugabe des gleichen Volumens n-Butanol sowie einiger Tropfen n-Hexylalkohol bereitet."

[translation by the board: Another approach, in which spontaneous crystallisation occurred after several weeks of storage at +4°, was conducted by dissolving amorphous trisaccharide in aqueous methanol and adding an equal volume of n-butanol along with a few drops of n-hexyl alcohol.]

3.3 Finally, D1 states (lines 19 to 22) that crystalline 2'-FL can also be obtained by using the crystalline products of the above two methods as seed crystals in the following method (denoted as "method 3" by the parties):

"Besitzt man Impfkristalle, so läßt sich die Fucosido-lactose (l g) durch Lösen in heißem 75-proz. Methanol (20 ccm) und allmähliche Zugabe von absol. Äthanol (60-80 ccm) leicht in schönen dreieckigen Plättchen (Abbild.) vom Schmp. 230-231° (Zers.) erhalten."

[translation by the board: If seed crystals are available, fucosido-lactose (1 g) can be easily obtained as nice triangular plates (see image) with a melting point of 230-231° (decomposition) by dissolving the crystals in hot 75% methanol (20 ccm) and gradually adding absolute ethanol (60-80 ccm).]

3.4 The above understanding of D1, i.e. that method 3 uses the crystals of method 1 or 2 as seeds, is consistent with the summary of D1 in paragraph [0003] of the patent and was also common ground between the parties at the oral proceedings before the board.

3.5 With respect to the crystalline 2'-FL obtained, D1 also states (lines 22 to 23) that it is non-hygroscopic.

This property of the crystalline 2'-FL is mentioned in D1 only after the description of method 3. Contrary to the appellant's view, however, this does not mean that this property characterises only the crystals resulting directly from method 3. In the present case, the crystals obtained by method 1 or 2 are used as seed crystals in method 3 (see above). This means that the crystals of method 3 are obtained from these seed crystals by further growth. Therefore, the board concurs with the respondent that it is not apparent why the crystals from method 3 should have different properties than those resulting from method 1 or 2. In summary, D1 can only be understood as meaning that the above property (non-hygroscopic) characterises the crystals of 2'-FL no matter which of the three disclosed methods is used.

4. D1 does not disclose XRPD reflections of the crystals from any method or the degree of their purity in w/w%. However, this does not mean that its disclosure cannot be novelty-destroying. To the extent that the teaching of D1 is sufficient for the skilled person, in light of their common general knowledge, to obtain the product of claim 1 (in other words: if D1 provides an enabling disclosure for the product of claim 1), D1 would be novelty-destroying to claim 1.

4.1 In this context, experiment 1 of D21 (page 2/20) is relevant. It reads as follows (text in square brackets added by the board):

"In order to repeat the Method 2 in Literature 1 [D1] the following experiment was carried out: 2.527 g of amorphous 2-FL [2'-FL] was dissolved in 100 ml of aqueous methanol (99 ml of anhydrous methanol + 1 ml of water), and the white solids were gradually dissolved under continuous stirring, the liquid became a white turbid liquid, and then 100 ml of n-butanol was added, and more white solids were precipitated. The solution was filtered to obtain a colorless transparent solution, and then 400 myl of n-hexanol was added to the filtrate, and shaken. The solution was transferred to a 250 ml conical flask, sealed with a parafilm perforated with several small holes, and stored at 4 °C for 2 weeks. The crystalline product was filtered, washed with methanol, and dried in vacuo to obtain 0.314 g of white crystals."

4.2 The board agrees with the respondent that experiment 1 of D21 is a proper repeat of method 2 of D1, i.e. a repeat which the skilled person would have carried out having their common general knowledge in mind. In particular, in both method 2 of D1 and experiment 1 of D21, amorphous 2'-FL is dissolved in a certain volume of aqueous methanol and the solution is diluted with the same volume of n-butanol. Afterwards, a few drops of n-hexanol are added and crystallisation is carried out at 4 °C.

4.3 As is evident from figure 4 and table 1 of D21 (pages 10/20 and 11/20), the crystals obtained from this repeat show the XRPD reflections recited in claim 1. This was also never disputed by the appellant.

4.4 Furthermore, as already set out above, D1 uses a 2'-FL as the starting material for its crystallisations which had previously been purified by repeated chromatography or via its tosylhydrazone. D1 (last sentence) also states that no other sugars could be detected in the mother liquors by paper chromatography after crystallisation.

Against this background, at least in the absence of any evidence to the contrary, which the appellant did not provide, the board is convinced that the crystalline 2'-FL obtained according to the disclosure of D1 and in particular method 2 does not contain any impurities.

5. The appellant submitted that D1 did not disclose method 2 in an enabling manner. In this respect, it referred to paragraph [0016] of the patent, stating that the inventors of the patent had never been able to reproduce the methods described in D1. Decisions T 325/16 and T 605/02 were relevant in this context. In particular, the appellant argued that several pieces of information were lacking in D1 so that especially method 2 might not be reproduced. Experiment 1 of D21 filled in these gaps in the disclosure of method 2 of D1. Contrary to D21, D1 did not specify the amounts of solvents or 2'-FL used nor did it exactly specify the number of drops of n-hexanol added or the storage time; moreover, D21 disclosed that the liquid became a white turbid liquid, an item of information that was not mentioned in D1. Therefore, several additional assumptions had been made in D21 that could not be derived from D1 nor from the skilled person's common general knowledge. The appellant also pointed to the fact that, according to D21, the crystalline product was obtained after only two weeks, whereas D1 disclosed the obtention of the crystals after "several weeks".

Furthermore, the appellant referred to D6 and submitted that it was evident from figure 1 of D6 (page 946) that several parameters such as e.g. choice of solvent, temperature, concentration, agitation and pH all had an effect on the type of polymorphic form that was obtained from a solution during crystallisation. Therefore, it was entirely conceivable that the polymorph as defined in claim 1 had been obtained in D21 by selecting appropriate operating conditions that were not mentioned in D1 but that only slight changes in the crystallisation conditions of experiment 1 of D21 would have resulted in a different polymorph.

Hence, the appellant argued that D21 was not a proper repeat of method 2 of D1 and therefore it could not be concluded that the 2'-FL polymorph of claim 1 was necessarily obtained when following the teaching of method 2 of D1.

6. The board is not convinced by these arguments for the following reasons.

6.1 It is clear that method 2 of D1 is not described to the very last detail. However, this does not allow the conclusion that the method is necessarily not disclosed in an enabling manner. In the present case, the board is convinced that the skilled person, having their common general knowledge in mind, would have known how to put method 2 of D1 into practice. The appellant's arguments are not suitable for casting doubt on this for the following reasons.

6.1.1 First of all, both the storage time at 4 °C (2 weeks) and the amount of n-hexanol (400 myL, i.e. about 8 drops) reported in D21 are fully in line with the disclosure of method 2 in D1 ("nach mehrwöchigem Aufbewahren" [translation by the board: after several weeks of storage], "sowie einiger Tropfen n-Hexylalkohol" [translation by the board: along with a few drops of n-hexyl alcohol]). In the absence of evidence to the contrary, which the appellant did not put forward, the board sees no reason to doubt that the skilled person would very well have chosen the storage time and number of drops of n-hexanol as stated in experiment 1 of D21.

6.1.2 Secondly, it is true that the amounts of solvents and 2'-FL used in experiment 1 of D21 are not disclosed in D1. However, the skilled person is well aware that any compound which is to be crystallised from a solvent or a solvent system has a certain solubility at a certain temperature in said solvent (system). Consequently, depending on the amount of compound to be crystallised, the skilled person would have used only those amounts of solvent(s) which result in a concentration of the compound to be crystallised which is above the solubility limit at the crystallisation temperature, because no crystallisation at all could otherwise have been achieved. In simpler terms, as argued by the respondent, the skilled person would have known how much solvent to use depending on the amount of 2'-FL to be crystallised. This is what has been done in experiment 1 of D21.

6.1.3 Thirdly, D21 also states that "the liquid became a white turbid liquid" upon dissolution of the amorphous 2'-FL in aqueous methanol. The appellant pointed to the fact that this observation is not described in method 2 of D1. This argument implies that according to the appellant, the solution in D1 must have been clear upon dissolution of the amorphous 2'-FL in aqueous methanol. However, in the absence of evidence to the contrary, which the appellant did not provide, the board sees no reason for this assumption. In fact, according to experiment 1 of D21 (loc. cit.), a clear solution is obtained by filtration. Thus, the board is satisfied that this is exactly what the skilled person would have done by following method 2 of D1 if they had wanted to prepare a solution from which a compound was to be crystallised.

6.2 Therefore, the appellant's arguments cannot change the conclusion above that method 2 of D1 is disclosed in an enabling manner and that experiment 1 of D21 is a proper repeat of method 2 of D1, i.e. a repeat which the skilled person would have carried out having their common general knowledge in mind.

6.3 In view of the above, the mere assertion in the patent that the appellant tried in vain to repeat the methods of D1 is not convincing. In fact, as submitted by the respondent, the appellant has not provided any details concerning the operating conditions that might have been used in these attempts to reproduce the methods of D1 and which would not have allowed crystallised 2'-FL to be obtained.

6.4 It may be that, as argued by the appellant with reference to D6, a slight modification of the crystallisation conditions of experiment 1 of D21 could have in principle resulted in a different polymorph. However, the allegation that such is exactly the case here has never been proven by the appellant and, thus, amounts to mere speculation.

6.5 The appellant also referred to decisions T 325/16 and T 605/02, arguing that a polymorph disclosed in the prior art in a non-enabling manner could not be novelty-destroying. The board had already pointed out the lack of relevance of these decisions in its communication pursuant to Article 15(1) RPBA 2020 (see point 3.4.8). This is because the underlying facts were different from the facts at hand. Moreover, as set out above, the board is convinced that the polymorph defined in claim 1 is disclosed in D1 in an enabling manner. At the oral proceedings before the board, the appellant no longer relied on these decisions in its argumentation. Hence, the board sees no reason to comment on them further.

7. Therefore, the board concludes that method 2 of D1 is disclosed in an enabling manner and that it results in the claimed 2'-FL polymorph without any impurities. Hence, the subject-matter of claim 1 of auxiliary request 2 is not novel over D1. Auxiliary request 2 is not allowable.

Main request and auxiliary request 1 - Claim 1 - Novelty (Article 54 EPC)

8. Claim 1 of auxiliary request 1 differs from claim 1 of auxiliary request 2 only in that it allows for a higher degree of impurity ("less than 10 w/w% of impurity" in claim 1 of auxiliary request 1 vs. "less than 5 w/w% of impurity" in claim 1 of auxiliary request 2). Claim 1 of the main request (claim 1 as granted) does not set any limit to the amount of impurity.

Therefore, the subject-matter of claim 1 of auxiliary request 2 is fully encompassed by the subject-matter of claim 1 of the main request and auxiliary request 1. The above reasoning of lack of novelty for the subject-matter of claim 1 of auxiliary request 2 therefore also applies to the subject-matter of claim 1 of the main request and auxiliary request 1.

It follows that the subject-matter of claim 1 of these requests is not novel over D1 and therefore the main request and auxiliary request 1 are not allowable.


19 March 2024

T 0223/23 - Product claims based on inventive preparation method

Key points

  • Application filed in 2021, appeal decision on the grant on 08.01.2024. Things could be improving.
  • "Claim 1 of the main request related to:

    "A trace element solution, which comprises at least the following metals: (a) zinc in a concentration of at least 60mg/ml; (b) manganese in a concentration of at least 10mg/ml; (c) selenium in a concentration of at least 5mg/ml; and (d) copper in a concentration of at least 15mg/ml; and which comprises a concentration of the metals of at least 90 mg/ml."

  • "The application relates to a solution containing trace elements useful for administration to mineral deficient animals such as livestock. It seeks to address the problem of low concentrations of the minerals in injectable solutions, leading to the injection of large quantities, which causes tissue damage and abscesses at the site of injection. The invention aims at providing solutions with suitable composition with high enough concentrations and sufficient ratios and sufficient concentrations of the various metals"

  • The application discloses a rather specific method of making the solution, by adding various salts in a particular order to water, and also adding EDTA in a specific step.

  • The closest prior art D1 (see example 6) shows a trace element solution

  • The desirability of a higher metal concentration and the ensuing advantages upon injection are known from D1 (see page 1) and are as such obvious. However, it is apparent that, at the date of filing of the application, there was no obvious way to produce a solution as claimed with a metal concentration of at least 90 mg/ml.

  • As a quick test, what is the decision you need in such a case?

  • "the increased concentration of trace elements in solution is obtained [in the application] in particular by a specific order of adding EDTA. The prior art does not allow the skilled person to anticipate that this particular order of addition would lead to the claimed higher concentrations, nor does it appear to suggest any obvious way leading to such high concentrations."

  • "According to established case law, a product which can be envisaged as such with all characteristics determining its identity including its properties in use, i.e. an otherwise obvious entity, might nevertheless become non-obvious and claimable as such, if there is no known way or applicable (analogous) method in the art for making it and the claimed methods for its preparation are therefore the first to achieve this and do so in an inventive manner "

  • See T 0595/90 Kawasaki Steel


  • These criteria are met.
  • "The examining division however found that the criteria of Article 84 EPC were not met"
  • "The examining division argued that it was the process of manufacturing, and in particular the specific order of adding EDTA, that provided the trace element in solution.

    As a preliminary remark, claim 1 relates to a product per se. Additionally defining this product in terms of the process used for its preparation, i.e. by a product-by-process feature, could only further characterise the composition insofar as this process gives rise to a distinct and identifiable characteristic of the product. In this sense, the steps of the process cannot themselves be regarded as essential features of the product: at most the technical features imparted by this process to the resulting product could represent such essential features."

  • "The Board understands the examining division's conclusions to be motivated by the finding that the preparation of a trace elements solution with the claimed high concentration could not be achieved in the prior art and was part of the problem to be solved mentioned in the application, and that the process disclosed in the application was the first process to allow such a preparation (as explained above, see 3.2). However this situation does not justify that each and every feature imparted by the process shown in the example to the resulting composition be seen as an essential feature. As explained in T 242/92, the mere fact that only one way of carrying out the invention is indicated does not in itself offer grounds for considering that the application is not entitled to broader claims (see point 3 of the reasons). A lack of support would only arise if there are well-founded reasons for believing that the skilled person would be unable to extend the particular teaching of the description to the whole of the field claimed by using routine methods. The Board sees no such reasons in the present case. In particular, the absence of reference in claim 1 to the EDTA used in the example does not lead to a lack of support, considering that the description mentions EDDS as an alternative, and considering the absence of an indication that the skilled person could not use other chelants."

  • "For the reasons given above (see 4.1.3), even if, according to the description, the invention aims at providing a highly concentrated trace element solution, and provides for the first time a process allowing the preparation of such a highly concentrated solution, this does not mean that the claims should be limited to that particular process or to a solution defined in terms of that particular process for them to comply with Article 84 EPC."


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


18 March 2024

T 1845/21 - CPA is a set of features disclosed in combination; multiple CPA

Key points

  • "The specific starting point for assessing inventive step is normally a set of features disclosed in combination in a document, e.g. an embodiment or example."
  • " For assessing inventive step it is necessary to establish the distinguishing features over that specific starting point and assess whether it was obvious to arrive at the claimed subject-matter when starting from that specific point (T 1287/14, Reasons 5.2.1)."
  • Disclosure, however, can be implicit.
  • D3, Example 3 is the closest prior art.
  • "The combination of all these features (toddler milk of example 3, which in view of the above [considerations] implicitly comprises LC-PUFA, and [implicitly ] for use in preventing infections) is considered the closest prior art for examining the inventive step of claim 1."

  • "Prior to identifying the closest prior art in its statement setting out the grounds of appeal, appellant 1 extensively outlined what it deemed to be common general knowledge. While a brief introduction of the common general knowledge prior to identifying the closest prior art may occasionally be helpful, an extensive discussion on this matter bears the risk of adding hindsight to a party's argument. Such a discussion might undo the desired effect of the problem-solution approach, namely to assess inventive step as objectively as possible, although the assessment is unavoidably made in full knowledge of the invention. Nevertheless, the board understands appellant 1's submissions ..."
Multiple starting points

  • D45a was also proposed as the closest prior art.
  • "A discussion of the entire problem-solution approach starting from a document as a further starting point may be dispensed with if, following a discussion on whether the document is suitable as the closest prior art, the board concludes that this is not the case (see T 1230/15, point 2.4)."
  • "The understanding that a party is not generally entitled to orally present an entire problem-solution approach at oral proceedings is also conveyed in R 5/13 (Reasons, 14 and 15). Such an approach ultimately serves procedural economy."
  • " D45a relates to an announced study on the effect of growing-up milk on the occurrence of infections in toddlers. The hypothesis underpinning the study is the expectation that drinking growing-up milk with added "prebiotics and LCPUFA" results in a lower occurrence of infections."
  • "without the benefit of hindsight, D45a would have provided the skilled person with next to no useful information. ... It is worth noting that in the current case, hindsight is particularly difficult to put aside, the reason being that the results of the study are described in D35, published after the filing date of the patent. D35 is also the document that appellant 1 discussed in detail throughout the appeal proceedings, e.g. in the context of sufficiency of disclosure. Moreover, the results of the study are summarised in example 1 of the patent."
  • " To conclude, the disclosure of D45a is vague and blurred, so this document is not considered a more promising springboard than D3 for assessing the inventive step of claim 1." 
  • Inventive step over D45a is no further discussed.
EPO 
The link to the decision is provided after the jump, as well as (an extract of) the decision text.

15 March 2024

T 0298/20 - Specific for sufficiency, specific for inventive step

Key points

  • The claim is a second medical use claim.
  • "D6 (points 1 and 3) is a draft of the guidelines proposed by a group of experts consulted by the FAO and the WHO for evaluating the use of therapeutic probiotics in food. In the first paragraph of point 3.1, D6 underlines the importance of identifying probiotic strains because, according to the available evidence, the effect of probiotics on health is strain specific. "
  • For sufficiency: "It follows from D6 and D7 that on the filing date it was generally accepted that the health benefit provided by a probiotic was strain specific. Only in exceptional cases had it been observed that the effect of a strain was common to the whole species. There is no experimental evidence on file that the health benefits obtained by the administration of L. acidophilus NCFM and B. lactis Bi-07 [as used in the examples] can also be obtained with other strains of the species L. acidophilus and B. lactis [as encompassed by the claim]."
  • " Therefore, the Board has serious doubts that, on the filing date, the skilled person could carry out the invention of claim 1 without undue burden. As a consequence, the ground for opposition of Article 100(b) EPC precludes the maintenance of the patent as granted."
  • Turning to inventive step of AR-3 where the claim is limited to the specific strains that were tested, " the subject-matter of claim 1 differed from D2 at least in the combination of bacterial strains that were administered to children. In claim 1, it was a combination of L. acidophilus NCFM and B. lactis Bi-07, while in D2 it was a combination of L. rhamnosus GG or L. delbrueckii bulgaricus and B. lactis Bb-12."
  • "the results of the clinical study in the patent (see Tables 2 and 3 and paragraph [0097]) demonstrate that the administration of the bacterial strains in claim 1 prevents or reduces flu-like symptoms in children affected by respiratory tract infections. Therefore, the objective technical problems is, as proposed by the patent proprietor, the provision of a probiotic composition for reducing or preventing flu-like symptoms in a child affected by a respiratory tract infection."
  • 'As concluded for sufficiency of disclosure of the main request (point 5.2 above), on the priority date, it was generally accepted by the scientific community that the beneficial effects of probiotics on human health were strain dependent. The fact that L. acidophilus NCFM and B. lactis Bi-07 were known probiotics did not provide the skilled person with a reasonable expectation that they would have an effect on the flu-like symptoms of children affected by respiratory tract infections. Neither of the two strains had been disclosed to have such an effect."
EPO 
The link to the decision is provided after the jump.