T 0667/23 - A difference no matter how small

Key points

•  "D1/D1a discloses an alloy C1 falling within the scope of claim 1 except that alloy C1 contains 1.00 wt.% Si. The opponents mainly argued that the lower endpoint of the claimed range (1.03 wt.%) could not establish novelty since it was not far removed from the example. Reference was made to decision T 673/12.
• "The board is not convinced by the opponents' arguments.
• "The concept that a claimed sub-range must be "narrow" compared to the known range and "sufficiently far removed" from any examples disclosed in the prior art originates from decisions T 198/84 (Reasons 5), which is summarised briefly in T 279/89 (Reasons 4.1). It has been accepted as a kind of novelty test for selection inventions. "
• "This board agrees with T 1688/20 (Reasons 3.2.1) that this concept is not in agreement with direct and unambiguous disclosure, which is the uncontested criterion established later on in the case law for evaluating novelty. As explained in T 1688/20, the relative terms "narrow" and "sufficiently far removed" do not provide objective, solid and consistent criteria for establishing the novelty of a selected sub-range. Therefore, these terms are dependent on the case and context and involve considerations linked to the technical effect of the range. Consequently, the concept cannot be reconciled with direct and unambiguous disclosure. It is instead considered to be relevant for inventive step. In fact, neither T 198/84 nor T 279/89 even mentions direct and unambiguous disclosure."
• The difference is the Si content is neither found to provide a technical effect nor an inventive step.

EPO 

The link to the decision can be found after the jump.

T 0213/23 - Diluted seawater

Key points

• D10 is "D10: L'Eau de Mer... 1904 Rene Quinton Book"
• "D10 is a book published in 1904 and written by Mr Quinton. It indicates that the composition of seawater is different depending on its origin (see page 217). Page 219 of D10 shows the composition of seawater of different origins, while page 223 indicates that seawater contains nitrite or nitrate. The Table of D10 reproduced by the appellant on page 21 of its statement of grounds of appeal gives the concentrations of elements in seawater which do not fall under the scope of the claim. For instance, it can be easily calculated from the amounts of NaCl in 1L of seawater of different sources that the concentration of chlorine or sodium, is above 400 mmol/L."
• Claim 1:  "1. Isotonic crystalloid aqueous solution, comprising Na**(+) ions in a range comprised between 50 and 200 mmol/ L, K**(+) ions in a range comprised between 1 and 10 mmol/ L, Cl**(-) ions in a range comprised between 50 and 200 mmol/L, characterized in that it has nitrate ions or nitrite ions or mixtures thereof in a range comprised between 0.0001 mmol/L and 1 mmol/L and at least a chemistry element selected from: Li, Be, B, Al, Si, P, Sc, V, Cr, Mn, Fe, Co, Ni, Cu, Zn, As, Br, Rb, Sr, Y, Zr, Mo, Pd, Ag, Sn, Sb, I, Cs, Ba, Ce, Au, Tl, Pb, Bi, Th and U."
• "D11 and D12 are extracts of the "Dictionnaire Vidal" from respectively 1966 and 1975. They indicate that the "Plasma de Quinton" is a dilution of natural seawater which can be either isotonic or hypertonic, and which can be used as blood reconstitution product. None of these documents gives however the exact composition of the product "Plasma de Quinton". Furthermore, none of these documents indicates how much the seawater was diluted to obtain the product Plasma de Quinton."
• "Consequently, it is not possible to conclude that the product "Plasma de Quinton" is novelty-destroying in the absence of any precise qualitative or quantitative information on its constituents."
• The opponent is  "Laboratoires Quinton International, SL" 
• It currently sells "Plasma de Quinton is a 100% natural seawater isotonic solution. It is a dietary supplement made from pure seawater, collected from phytoplankton vortexes and subsequently diluted with spring water, which has very low mineralization. It undergoes a cold microfiltration process at 0.22 microns in order to ensure total safety." (https://quintonmedical.com/quinton-plasma) 
• Of course, this does not give any information about the composition of this commercial product. 
• " The claimed invention relates to an isotonic crystalloid aqueous solution used to replace fluids, primarily blood, which does not present oncotic pressure per se and which intends to yield better results than the already known blood substitute solutions or a solution of ionic solutes"
• "D10 as closest prior art - D10 is a book dated 1904 and relating to seawater which comprises 519 pages. The appellant cited page 459 as possible starting point, where it is disclosed that seawater can be injected to treat different diseases, without any mention of the use as blood substitute. There is furthermore no information, neither in D10, nor in D11/D12 on the degree of dilution of the seawater in the product "Plasma de Quinton" or of the origin of the seawater, and therefore on the final concentration of all possible elements originating from seawater. In the Board's view, assessing inventive step starting from a document that does not provide any clear information regarding the composition and pharmacological properties of the relevant product can only be made with the benefit of hindsight."

• " Accordingly, the Board considers that the claimed invention is inventive over D10. In the Board's view, there is indeed no teaching in any of documents D10, D11 or D12 to adapt or change the concentrations of the seawater elements in order to arrive at the claimed subject-matter. The argument of the appellant that the different elements can be easily changed with distilled water is a clear ex post facto analysis and cannot be followed."" 

• "D1 discloses physiologically acceptable aqueous solutions for use as plasma substitute comprising a carboxylic acid as a dynamic buffering system, an oncotic agent selected from a simple sugar or hydroxyethylstarch (hetastarch), and a buffer"

• "The patent provides a comparison between a composition according to the invention shown in Table 1 and the Plasmalyte® solution which does not comprise any nitrite/nitrate and/or metal, but includes acetate and gluconate (cf. Table 2 of the specification). The solution of the present invention showed an effect comparable to the administration of whole blood and a clear improvement with regard to the Plasmalyte® solution "

• "In view of these results, the Board is of the opinion that the problem over D1 should be defined as the provision of an improved blood substitute composition."

• " There is no suggestion or incentive in D1 to add other compounds such as a metal compound or a known vasodilator, such as a nitrite or a nitrate, or to replace the oncotic agent in the disclosed compositions. Accordingly, the claimed solution appears to be inventive over D1."

• The appeal of the opponent is dismissed.

EPO 

The link to the decision can be found after the jump.

T 2510/18 - Traditional knowledge, alleged biopiracy, and novelty of natural products

Key points

• Article 53 EPC
•  The Board, in translation: "in the early 2000s, the respondent [proprietor] conducted research on traditional anti-malarial remedies among the populations of French Guiana. As part of this project, a survey was conducted in 2001. 117 people from different communities in French Guiana responded to this questionnaire. The traditional remedies used for the treatment of malaria were collected. The project led to the identification of 45 curative recipes involving the use of 27 species of plants. The researchers studied these traditional remedies and subsequently focused their efforts on studying the plant Quassia amara. As a result, the researchers managed to identify an anti-malarial molecule, SkE."
• The molecule is now claimed: claim 1 is a compound claim directed to the molecule SkE.  
• "These observations [submitted by the appellants/opponents] were not contested by the respondent [proprietor] and can therefore be considered as facts."
•  "As indicated by the respondent [proprietors] , none of the appellants' allegations concern the commercial exploitation of the invention, a prerequisite for concluding that the invention would be excluded under Article 53 EPC."
• " the commercial exploitation of this molecule, of the drug containing it and of its isolation process is not contrary to morality, good customs or public order. On the contrary, there is a great need for drugs against malaria, and finding new antimalarial drugs is a mission whose aim is to treat populations at risk and save lives."
• "In the present case, the original development of the invention and the historical process by which the SkE molecule was discovered and isolated have no relevance to the commercial exploitation of the present claims, which require only the isolation of SkE from the plant Quassia amara and its administration to patients. The development of an invention is therefore distinct from its commercial exploitation once it has been achieved."
• "even if the respondent's conduct during the discovery and development of the invention as described by the appellants above were considered to be contrary to good morals and public policy, this does not concern the commercial exploitation of the invention, and therefore does not constitute a reason to exclude the claimed invention from patentability under Article 53(a) EPC."
• I refrain from adding comments on this point of the decision. 
• 
  
• Novelty of natural products
• Claim 1 recites the molecule. I understand that the molecule as such is present in the leaves or stems of a particular plant, Quassia amara. The claim does not recite 'isolated' or 'purified', only the structural formula of the molecule. Is it novel? 
• EPO Guidelines, G-II,3.1 "To find a previously unrecognised substance occurring in nature is also mere discovery and therefore unpatentable. However, if a substance found in nature can be shown to produce a technical effect, it may be patentable. An example of such a case is that of a substance occurring in nature which is found to have an antibiotic effect."
• Here, implicitly, "patentable" means not excluded by Article 52(2), novel and inventive, in combination. Hence, the Guidelines here kind of say that there are no novelty issues on the ground that the compound, as such (and as claimed), existed in nature before. In particular, "it", i.e. the substance, may be patentable, not only the method or use wherein the technical effect is achieved. 
• I'm looking for the EPO case law that supports the statement in the Guidelines.
• Of course, the German decision is BPatG 28.07.1977, 16 W (pat) 64/75, GRUR 1978, 238 Antamanid (no open access copy known to me): "Aber selbst wenn der beanspruchte Stoff Antamanid nachweisbar als solcher in der Natur vorkommen würde, stünde diese Tatsache einer Patentierung nicht entgegen." "Das beanspruchte Antamanid ist neu. Geht man von der Identität des beanspruchten Antamanids und dem im grünen Knollenblätterpilz enthaltenen Stoff als, so steht dieser Umstand der Neuheit der vorliegenden Erfindung nicht entgegen. Nach § 2 PatG gilt eine Erfindung nicht mehr als neu, wenn sie zur Zeit der Anmeldung in öffentlichen Druckschriften bereits derart beschrieben oder im Inland bereits so offenkundig benutzt ist, daß danach die Benutzung durch andere Sachverständige möglich erscheint. [this is the old German law] Am Anmeldetag war aber kein Sachverständiger in der Lage, das cyclische Dekapeptid Antaminid mit der in Anspruch 1 angegebenen Formel zu benutzen. Ihm war der Stoff als solcher und erst recht dessen wertvolle Eigenschaft, nämlich die Wirkung einer absolut tödlichen Dosis Phalloidin aufzuheben, unbekannt, Die Tatsache der Existenz dieses Stoffes in der Natur ist aber für sich genommen noch kein neuheitsschädlicher Umstand, sofern nicht die Kenntnis des Durchschnittsfachmanns von dieser Existenz hinzukommt. Nur ein öffentlich zugänglicher Naturstoff ist im Sinne des Gesetzes nicht mehr neu." . 
• I would be grateful to learn about the corresponding decision of the Technical Boards of Appeal.
• The court in the Antamanid case referred to the identical sentence in the first edition of the EPO Guidelines. 
• "Documents D2, D3 and D5 therefore do not explicitly disclose the SkE molecule or SkE in combination with other compounds. Rather, these documents disclose traditional antimalarial remedies, i.e. preparations derived from the leaves or stems of a particular plant, Quassia amara."
• 3.14: "even if one accepts the presence of SkE in the extracts of D2, D3 and D5, and even interpreting the scope of claim 1 in the broadest possible manner, as the applicants argue, for example to include the plant Quassia amara and its extracts disclosed in D2, D3 and D5, a direct and unambiguous disclosure of the technical features of claim 1, or even of the SkE molecule alone or in combination with other compounds, is still necessary to conclude a lack of novelty. 
•  See also point 4.4.2: " Although the scope of claim 1 may include preparations as set out above,"
• "There is no question of implicit disclosure of the SkE molecule or its combination with other compounds in these documents either. According to the consistent case law of the Boards of Appeal, a prior art document destroys the novelty of the claimed subject-matter if it follows directly and unambiguously from that document, including features implicit for the person skilled in the art. However, an alleged disclosure can only be considered "implicit" if the person skilled in the art immediately recognizes that nothing other than the alleged implicit feature is part of the disclosed subject-matter ... This situation does not apply to the SkE molecule and its combination with other compounds."
• "The fact that the SkE molecule may be contained in the extracts of D2, D3 and D5 does not amount to an implicit disclosure either. According to the decision of the Enlarged Board of Appeal in G 2/88 (points 10 and 10.1 of the Reasons), the question is what has been made available to the public, not what could be inherently contained in what has been made available to the public. Even if that decision concerned a use, the same applies in the present case: the presence of the SkE molecule in the leaves of Quassia amara or their decoction has not been made available to the public by the extracts of D2, D3 or D5."
• G 2/88 was about second non-medical uses. However, the remark is there in point 10.1 - imprecise in my view: "the Enlarged Board would emphasise that under Article 54(2) EPC the question to be decided is what has been "made available" to the public: the question is not what may have been "inherent" in what was made available (by a prior written description, or in what has previously been used (prior use), for example). Under the EPC, a hidden or secret use, because it has not been made available to the public, is not a ground of objection to validity of a European patent. In this respect, the provisions of the EPC may differ from the previous national laws of some Contracting States, and even from the current national laws of some non-Contracting States. Thus, the question of "inherency" does not arise as such under Article 54 EPC. Any vested right derived from prior use of an invention is a matter for national law (see, in this connection, e.g. Article 38 of the Community Patent Convention, not yet in force).". 
• Note, indeed 'secret prior use' is no prior art. That, however, is not very relevant to the issue of novelty of a second non-medical use claim over a public prior use of a method (with the same method steps) as at hand in G2/88, nor to the public prior use of the extracts for treating malaria in the case at hand. The EBA's term 'hidden prior use' is unclear to me, I'm unaware of a legal definition of it.
• In my view, at least for product claims and method claims, it is  relevant "what may have been "inherent" in what was made available (by a prior written description, or in what has previously been used (prior use), for example)."
• Thanks to the IP Kat comment: "Lord Hoffman's comments in Merrell Dow Pharmaceuticals Inc v HN Norton & Co Ltd [1995] UKHL 14 (26 October 1995): 
  "There is an infinite variety of descriptions under which the same thing may be known. Things may be described according what they look like, how they are made, what they do and in many other ways. Under what description must it be known in order to justify the statement that one knows that it exists? This depends entirely upon the purpose for which the question is being asked. Let me elaborate upon an example which was mentioned in argument. The Amazonian Indians have known for centuries that cinchona bark can be used to treat malarial and other fevers. They used it in the form of powdered bark. In 1820, French scientists discovered that the active ingredient, an alkaloid called quinine, could be extracted and used more effectively in the form of sulphate of quinine. In 1944, the structure of the alkaloid molecule (C20H24N2O2) was discovered. This meant that the substance could be synthesised. 
  Imagine a scientist telling an Amazonian Indian about the discoveries of 1820 and 1944. He says: "We have found that the reason why the bark is good for fevers is that it contains an alkaloid with a rather complicated chemical structure which reacts with the red corpuscles in the bloodstream. It is called quinine." The Indian replies: "That is very interesting. In my tribe, we call it the magic spirit of the bark." Does the Indian know about quinine? My Lords, under the description of a quality of the bark which makes it useful for treating fevers, he obviously does. I do not think it matters that he chooses to label it in animistic rather than chemical terms. He knows that the bark has a quality which makes it good for fever and that is one description of quinine."
• Incidentally, I believe there were indeed some national laws in Europe that at one time considered even secret prior use to be part of the state, but I would have to find a source for more details.
• In my article in EPI Information 2020/4, I wrote that "it is established case law that the ‘falling within’ test for lack of novelty can be satisfied based on inherent features of the prior art subject-matter", footnote: "T 12/81 hn.1, see e.g. also T 680/00, r.3. The exceptions are, of course, the special rules for first and second medical uses of Art. 54(4) and (5) EPC 2000, and the special rule for second non-medical use claims of G 2/88; however, these exceptions could also be seen as special rules for claim interpretation (cf. T 308/17, r.7). The remark in G 2/88, r.10.1 that ‘the question of “inherency” does not arise as such under Article 54 EPC’ is probably restricted to use claims as considered therein."
• T12/81, point 6 of the reasons: "If inventions relating to chemical substances defined by claims of this kind are patented, it necessarily follows that the resulting patent documents, once they enter the state of the art, will be prejudicial to the novelty of applications claiming the same substance although in a different and perhaps more closely defined form. This is the case with the present application."
• The present Board does not seem to be of the view that  G 2/88, r.10.1  is limited to use claims.
• Note that the Board expressly states that the claim is novel even if understood as covering "the plant Quassia amara and its extracts" (such extracts undisputedly being known from D2, D3 and D5) (point 3.14; see also point 4.4.2. Hence, the claim covers extracts that were described in scientific articles, e.g. D2: M. Vigneron et al., Journal of Ethnopharmacology 98 (2005), 351-360. These extracts are now patented.
• "D2 is an article that describes a study of antimalarial remedies used in French Guiana. The study found that the most commonly used species was Quassia amara alone or in combination with other plant species [...]. D2 describes that this plant is used in the form of decoctions [i.e. extracts] in water". 
• Hence, D2 discloses technical teachings about the plant and the extract and how to use it in a practical manner. It does not seem that the inventor of the patent discovered the plant or found a practical, technical use for the plant or a use of the extract from it. 
• I believe that in the Antamanid case, there was no known technical use of the poisonous mushroom (death cap) from which it was isolated. 
• Also, the court in that case did not explicitly state that the claim (reciting the compound as such) covered the mushroom. The court held that it could leave open the question of whether "eine ausdrückliche Beschränkung des Stoffanspruchs [to synthetic compounds] unnötig ist, weil es sich von selbst verstehen könnte, daß unter den Schutz des Patents nie das Naturvorkommen als solches fällt, kann hier wegen der mangelnden Nachweisbarkeit der Identität beider Stoffe unentschieden bleiben. Die Regelung im britischen Patentgesetz in Art. 4 Abs. 7 deutet in die Richtung, daß chemische Stoffe, die in der Natur als solche vorkommen, nicht unter das Patent fallen."
• The Board: "SkE was not disclosed in Documents D2, D3 and D5, and the molecule was not made available to the public through the use of Quassia amara leaves to prepare remedies disclosed in those documents."
• 
  
• On inventive step: "Although the scope of claim 1 may include preparations as set out above, the technical features of the claim relate to a specific compound. Therefore, the objective technical problem must also include the provision of a compound. Furthermore, as stated by the respondent, and not disputed by the appellants, the SkE molecule has low toxicity"
• "The objective technical problem can therefore be formulated essentially as proposed by the respondent, namely to provide a specific compound, or a preparation comprising a specific compound having good antimalarial activity and low toxicity. "
• The Board's review of inventive step is then quite detailed and fact-specific.
• "Therefore, the subject-matter of claim 1 involves an inventive step."
• "The same conclusion applies to claims 2 to 6, which depend on claim 1 and relate to a medicament comprising the SkE molecule"
• Claim 3 is a second medical use claim, in translation: "Medicament according to claim 2, for its use in the prevention and/or treatment of malaria". Claim 2 specifies "Medicament comprising the molecule of formula I according to claim 1 and a pharmaceutically acceptable carrier."  Depending on the interpretation of the claim term  "a pharmaceutically acceptable carrier", claim 3 could possibly cover exactly the already known use of the aqueous extracts of the plant to treat malaria, as known e.g. from D2 - which describes the traditional knowledge.

EPO 

The link to the decision and an extract of it can be found after the jump.

T 1375/22 - A range that is not narrow

Key points

• The Board, under inventive step, has to decide on the distinghuishing features.
• " The opposition division stated in reasons 7.4.2 that "the selection of a weight of 0.3 to 0.7 g within the range of 0.1 to 1.0 g could also be seen as novel" but saw no need to elaborate on this feature as "this had no bearing on novelty and inventive step"."
• " The Board shares the view of appellant (opponent 2), as pointed out in their statement of grounds of appeal, that the range of 0.3 to 0.7 g cannot be considered to be narrow compared to the known range of 0.1 to 1.0 g since it covers about half thereof and thus fails the novelty test as outlined in T 230/07."
• Compare T 1688/20 : " The question is whether the subrange defined in the claim provides for novelty. The prior art disclosure is 55 - 60, and the claimed range is  an angle of 56 degrees or more and 59 degrees or less"  (the Board in that case found the range novel).
• The distinguishing features are a smaller width and height (the case is about pouches of oral  tobacco).
• "This has the effect that the product becomes slimmer. Modifying the product known from D11 to become slimmer is, however, obvious to the skilled person. 
• "The skilled person knows that the size of an oral pouched smokeless tobacco product is limited since it is introduced between the user's gum and lip. It is obvious to the skilled person that a slimmer product may fit more discreetly and comfortably in the mouth of a user  "
• "By reducing the width of the product of D11, the skilled person hence arrives at the subject-matter of claim 1 according to auxiliary request 8 without any inventive step. "

EPO 

The link to the decision can be found after the jump.

T 1464/21 - Implicit disclosure and interpreting a cross-sectional drawing

Key points

• I think it is important to carefully distinguish between inherent features and implicit disclosure.
• "Furthermore, it is established jurisprudence of the boards of appeal that a disclosure can be implicit, where an implicit disclosure relates solely to matter which is not explicitly mentioned but is a clear and unambiguous consequence of what is explicitly mentioned (Case Law of the Boards of Appeal of the European Patent Office, 10th edition, July 2022, II.E.1.3.3). 
• The Board uses "clear and unambiguous consequence "
• Note, the different phrase "inevitable consequence" could be appropriate for inherent features : possibly with a focus on unpredictable inevitable consequences. Such features need not be clear from a document itself (e.g. reworking a described chemical experiment may be necessary  to find out exactly what product is obtained). (edits in italics)
• "Fig. 3A shows only a cross-section of the objective and therefore only a cross-section of the frame 30. However, the person skilled in the technical field under consideration would understand in the technical context of document D1, and in particular in view of Fig. 3A together with the cylindrical symmetrical configuration of the optical system represented in Fig. 3B, that a "frame" configured to fix the lens 29A to the deflection prism 29B (D1, column 4, lines 23 to 25) would - as held by the opposition division in its decision - be a frame encircling the lens. The board concurs in this respect with the appellant's view that it would be unrealistic ("lebensfremd") that the skilled person would construe the disclosure of document D1 relating to the frame as possibly only involving a frame constituted by two distinct portions separated from each other. For these reasons, in the board's view, document D1 discloses implicitly that the frame 30 encircles the lens 29A along its whole perimeter as this is a clear and unambiguous consequence of what is explicitly mentioned."
• Comment: D1 is a patent document, does this mean that an amendment of D1 to explicitly mention the feature ("the frame 30 encircles the lens 29A along its whole perimeter ") would comply with Article 123(2) ?

EPO 

You can find the link to the decision and an extract of it after the jump.