An Ocean Apart – Differences in US and EPO claim interpretation

Recent cases from the US Federal Circuit and the EPO Boards of Appeal highlight how the two jurisdictions have reached strict, and completely opposite, approaches to interpreting claims in light of the description. These cases demonstrate the need for care when drafting and amending specifications during examination, and consideration of different practices in different jurisdictions. We start in Europe, with decision T1628/21 (Nike Innovate C.V v Adidas AG), an appeal from an EPO Opposition about sports clothing that helps the wearer ‘feel’ body position, to help improve their form. Key to the case was a lower back position feedback system. To avoid prior art, Nike needed to argue that the feedback system was a separate component, distinct from the item of clothing itself. Nike’s patent claimed: “An article of apparel, comprising a garment structure (200)... characterised by a lower back position feedback system (202) engaged with the garment structure at the lower back portion”. The question for the Board was whether this formulation was restricted to a separate lower back position feedback system, or whether it could include a feedback system integral with the garment structure. To US eyes, this would be an easy question. Nike had explicitly stated in the description that integrally formed feedback systems “do not form part of the present invention”. Surely Nike’s claim could not encompass such disclaimed matter? Indeed, the EPO Board of Appeal did find this an easy question to answer, but reached completely the opposite conclusion. The Board stated that the “principle of primacy of the claims” excludes the use of the description and drawings for limiting the claims if an interpretation of the claim in the light of common general knowledge already leads to a technically meaningful result. In other words, if the claim is clear on its face, the EPO will not even look to the description to help with interpretation. The Board found that both possible interpretations (distinct and integral) were clear and valid from the claim alone, and so the claim lacked novelty over the prior art. Nike may have tried to disclaim subject-matter in the description, but the Board would only consider a disclaimer in the claim itself. It’s worth noting that one of the reasons the Board gave for considering “engaged with” to encompass the ‘integral’ meaning was the use of “characterised by” in the claim, which the Board suggested can be understood as introducing further limitations to the garment structure, rather than defining a necessarily "separate" further component. The wording “characterised by” was actually added by the examiner, not Nike, just before grant of the patent. This is part of the EPO’s insistence on using the “two-part form”, a form similar to the US Jepson-style claiming (without the Jepson format’s assumed admission of prior art). Although likely not decisive in this case, this is a reminder to at least consider arguing against use of the two-part form before the EPO. Turning to the US, the Federal Circuit’s decision in Chewy, Inc. v. International Business Machines Corp., 2022-1756 (Fed. Cir. Mar. 5, 2024) makes clear that the wording of the description is very important to US claim interpretation. The patent here related to presenting “advertising objects” on a computer. The question was whether the claim limitation “selectively storing advertising objects” necessarily involved pre-fetching the objects. Pre-fetching was described in the description, but not included in the claim. The Federal Circuit concluded that pre-fetching was required, because the written description “consistently describe[d]” pre-fetching. The Court took particular aim at the “Summary of the Invention” section of the description, which included the pre-fetching feature. Judge Moore noted this did not say a “preferred embodiment”, but rather “the invention”. Judge Moore also highlighted that the method in this section was described as a “method for presenting advertising in accordance with this invention”, which the Judge deemed to be “magic language...language that binds you, whether you like it or not”. Thus, the claim had to be read as including the pre-fetching limitation from the written description. In summary then, in Europe a patentee tried unsuccessfully to bind themselves with a disclaimer in the description. In the US, a patentee accidentally bound themselves by using, among other things, standard (at least in Europe) terms such as “summary of the invention”. So what is the moral of this story? Perhaps “the grass is always greener on the other side”? The patentees here would likely have appreciated the other jurisdiction’s rules. Or, more helpfully, ensure that your applications are drafted and prosecuted with an awareness of the conflicting rules on both sides of the Atlantic. And maybe even seek the help of a friendly trans-Atlantic patent firm, like EIP.

Spotlight

Court of Appeal affirms death of Bayer’s blood clotting patent in expedited hearing

The Court of Appeal announced at the conclusion of the hearing, on 16 May 2024, that Bayer’s appeal in the rivaroxaban litigation against a finding of invalidity following challenges by a number of generic pharmaceutical companies, which we have previously reported on (link), would be dismissed with reasons to follow. Lord Justice Arnold taking the lead in this judgment has now provided the Court of Appeal’s reasoning. Background The Hight Court found Bayer’s patent, which claims the use of rivaroxaban for the treatment of thromboembolic disorders for once-daily oral administration to a human patient, invalid for lack of inventive step over two pieces of prior art which were cited as “Harder” and the “Kubitza posters”. Bayer had already obtained a preliminary injunction from the High Court ahead of expiry of its compound patent on 1 April 2024, which we have previously reported on (link). The interim injunction was due to last until the hand down of the High Court judgment (12 April 2024) but the judge then extended it until 29 April 2024 in the form of order hearing heard of the same day. 29 April being the deadline for the Court of Appeal to make its decision on whether to grant Bayer permission to appeal the High Court’s decision. The Court of Appeal gave permission to appeal and extended the preliminary injunction until that hearing. Given the number of generic pharmaceutical companies interested in entering the rivaroxaban market and it being Bayer’s largest-selling drug, the Court of Appeal expedited the appeal and it was heard on 16 May 2024. Issues Bayer, as the appellants, were only given permission to appeal on two grounds, grounds 1, broken into three sub-grounds, and 5. As a result of having grounds 2, 3 and 4 refused, Bayer applied for permission to amend their grounds of appeal to raise a new ground (the “Application to Amend”). During the appeal hearing, Bayer’s counsel also advanced a further ground in oral argument without applying to amend Bayer’s grounds of appeal (the “Unpleaded Ground”). The Court of Appeal heard full argument on this despite the absence of any amendment application. The Application to Amend Bayer’s submissions revolved around the judge’s misunderstanding, misinterpretation and inconsistent approach of the evidence before him, which allegedly meant his assessment of obviousness was incorrect. In Bayer’s Application to Amend, the emphasis was that the judge had inferred too much into the status in the field of three of the authors of the Harder prior art (Dr Harder, Dr Misselwitz and Professor Breddin), leading to the skilled team simply taking the authors’ statements at face value. Lord Justice Arnold did not accept this submission, and instead found that the first instance judge’s findings were correct and rationally supported by the evidence before him. Grounds 1(1) and 5 In assessing the likelihood of success, Bayer claimed that the judge erred in law and principle by failing to apply the correct standard when considering the cited prior art together with the common general knowledge at the priority date (ground 1(1)) and that he failed to grapple with the key question of whether the skilled team would have a reasonable expectation of success based on the prior art (ground 5). Lord Justice Arnold did not accept these submissions on the premise that Bayer were misreading what the first instance judge was saying and not following his reasoning, nor had any error of principle been identified for ground 5. The Unpleaded Ground Bayer also claimed that the first instance judge’s acceptance of the respondents’ evidence was inconsistent as he seemed to have accepted the respondents’ experts’ evidence (one being an expert clinician and the other an expert pharmacologist) but went on to reject part of the respondents’ expert clinician’s evidence later in the judgment. Lord Justice Arnold did not accept this argument and reminded everyone that it is commonplace in patent cases for judges to accept the main thrust of expert witnesses’ evidence without accepting their evidence on every point. Additionally, the rejected part of evidence did not impact the pharmacologist’s evidence. Grounds 1(2) and (3) Bayer submitted that the first instance judge erred in placing weight on Bayer’s decision not to adduce “invention story” evidence in this jurisdiction, having done so in other jurisdictions. Lord Justice Arnold did not believe this to be correct and that the judgment made clear that the first instance judge did not place any weight on the absence of “invention story” evidence in reaching his conclusion as to obviousness. In fact, obviousness is to be objectively assessed from the perspective of the skilled person or team and the manner in which the inventor(s) actually gets to the invention is legally irrelevant. Conclusion The Court of Appeal concluded that the first instance judge made no error of principle in his assessment of obviousness. His conclusions were rationally supported by the expert evidence before him. The judgment is available here.

T 0192/22 - Is a first medical use claim a magic bullet?

The EIP team was pleased to receive the BoA Decision on T 0197/22 earlier this month, providing the reasons for revocation of Translate Bio’s EP 3318248 B1 at the oral proceedings held in March, where we represented one of the Opponents. The patent related to mRNA transfer vehicles, with the Main Request broadly being directed towards mRNA encapsulated in a liposomal formulation for use in therapy. This technology is highly relevant to those working in the field of mRNA-based therapies. Is a first medical use claim a magic bullet? Should a Proprietor be entitled to bar others from using a prior art transfer vehicle to deliver a nucleic acid for use in any therapy if their use together was not disclosed, despite how variable the resulting products’ mechanisms of action can be in vivo depending on the therapy? This case was particularly interesting due to the atypical first medical use claims at issue. First medical use claims under Articles 53(c) and 54(4) EPC typically spring to mind language such as “substance X for use as a medicament”, wherein “substance X” is an active ingredient (having a clear chemical composition) that has not been used in therapy before. In this case, however, the claims did not define what protein the mRNA should encode, what disease it should treat, or the composition of the liposome (other than its size and broad categories of required lipids). Indeed, all of these play a crucial role in achieving the desired therapeutic effect. Proteins encoded by mRNA molecules can have drastically different mechanisms of action depending on their purpose, which can range from vaccines to replacement therapies. This is in contrast to a new class of antibiotics, for example, where the members usually share the same mechanism of action. It is not generally required for a patent to show that a compound is suitable for each and every disease in order for a first medical use to be sufficiently disclosed. That said, how far can one exploit this without falling foul of Article 83 EPC? In the present case, as mentioned, the claims left the nature of the intended therapy, the encoded protein and liposome composition to be determined. This means that the patent sought to claim an entire platform of mRNA-based therapies, whilst only disclosing very limited data and no quantification of expression of any therapeutic protein. Ultimately, in the Decision, the Board came to the conclusion that the patent did not provide sufficient proof of concept regarding the suitability of the claimed formulations for use in therapy. The issue regarding how broadly one can define a genus composition in a first medical use claim while making only a single therapeutic effect plausible for one member of the genus is perhaps ripe for further clarification by the Boards of Appeal.

T 1762/21 – The EPO Board of Appeal Clarifies the Term “Inextricably Linked” When Assessing an Intermediate Generalisation

A recent decision from a Technical Board of Appeal of the European Patent Office provides clarity as to how “intermediate generalisations” are assessed for added matter. This decision states that certain features can be omitted from a claim if they are not necessary for achieving the technical effect of the claim. This potentially marks a shift towards greater flexibility for claim amendments, highlighting that not every disclosed feature must be defined in the claims if a skilled person would understand such features are not necessary. In this case, the Board emphasised that features unrelated to image optimisation in a breast tomosynthesis system can be left out of the claim if they do not contribute to optimisation of the acquired images, even if they contribute to the general functioning of the system. Background T 1762/21 concerns an appeal from the opponent. The appellant requested that the patent be revoked because, among other things, an amendment involved added matter. The appellant argued that several features, essential for the system of claim 1, had been omitted from the claim when being amended. They therefore argued that the claims contained an unallowable intermediate generalisation. The Patent The patent relates to a breast tomosynthesis system. Breast tomosynthesis is a three-dimensional imaging technology which acquires X-ray images of a breast at multiple angles during a short scan involving the movement of an X-ray tube. The individual images are then reconstructed into a series of thin high-resolution slices that can be displayed and analysed. Claim 1 as originally filed related to the X-ray tube itself. The X-ray tube has an anode, a cathode, a focusing cup, a port and a controller. The port allows X-rays to pass through to define a static focal spot, which impinges the breast. The controller is coupled to at least one of the anode, the cathode, and focusing cup, and modifies at least one characteristic of the static focal spot during the exposure period. Claim 2 defined two options: (i) the characteristic being a location of the static focal spot, or (ii) the characteristic being a size of the static focal spot. During prosecution, the claim was amended to focus on option (i) of claim 2, to define the tomosynthesis system as a whole (which comprises the X-ray tube), and to define in more detail how the controller controls the location of the static focal spot. Granted claim 1 therefore defined a system comprising the X-ray tube, a detector, and compression paddles (to hold the breast in place). Granted claim 1 further defined that the controller is configured to cause the X-ray tube to move in a first direction during the exposure period to move the static focal spot within the X-ray tube in a second direction, opposite from the first direction, so that a resulting effective focal spot appears to be fixed in space, relative to one of the breast and/or the detector, during the entire duration of the exposure. The result of this movement is said to increase image sharpness. Issues The main argument of the appellant was that claim 1 now defines a system, but several essential features from the description are omitted. They argued that the basis/support in the specification for defining a system could only come from paragraphs [0010] and [0020]. Those paragraphs read as follows: [0010] Figure 1 illustrates a breast tomosynthesis system 100 which includes an X-ray tube of the present invention. [0020] Figure 1 illustrates a tomosynthesis system 100 which includes an X-ray tube 110, upper and lower compression paddles 130, 135, an anti-scatter grid 140 and a detector 160. The X-ray tube 110 includes a cathode 112, an anode 114 that is mounted on a shaft 116 and rotated by a motor 118, a tube port 120. Also shown attached to the X-ray tube are a filter 122 and a collimator 124. The appellant argued that paragraph [0020] mentions several features that are not defined in claim 1, such as a scatter grid, the qualification of "upper and lower" for the compression paddles, and the configuration of the anode, a filter and a collimator. As a consequence of the omission of these features, embodiments other than those disclosed in the application as filed fall under the scope of protection. They therefore argued that the claims amounted to an intermediate generalisation. Board of Appeal Decision The Board of Appeal disagreed with the appellant. The Board stated that: “When assessing the allowability of an intermediate generalisation, it has to be established whether, because of this generalisation, the claim presents technical information which extends beyond what was directly and unambiguously disclosed, be it explicitly or implicitly, to the person skilled in the art using common general knowledge in the application as filed. This is the "gold" standard for assessing any amendment for its compliance with Article 123(2) EPC.” “The person skilled in the art is presented with subject-matter extending beyond the application as filed when an amended claim includes only some features of an originally disclosed combination and the features left out of the claim were understood, by the person skilled in the art, to be inextricably linked to the claimed ones. This is the case if the person skilled in the art would have regarded the omitted features to be necessary for achieving the effect associated with the added features. In such a situation, the amended claim conveys the technical teaching that the effect can be obtained with the claimed features alone, which is in contrast with and extends beyond the originally disclosed subject-matter that the whole combination of features was needed.” In this specific case, the Board noted that: “the features of these claims relate specifically to optimising the acquired images by acting on the focal spot. Features in the description concerned with other aspects of the system, such as the way the X-rays are generated or the way the breast is fixed in place on the detector, may be left out of the claims as long as they are not relevant to the optimisation, even if they contribute to the general functioning of the tomosynthesis system.” “the omission of a scatter grid, of the qualification of "upper and lower" for the compression paddles, of the anode being mounted on a shaft and rotated by a motor, of a filter, of a collimator, of a glass vacuum tube, of the cathode in the form of a heated filament and of the form of the focusing cup… is not problematic. The person skilled in the art would have recognised that the omitted features do not contribute to optimisation of the acquired images by acting on the focal spot…. The person skilled in the art would have been aware of several alternative mechanical arrangements for such control and is thus not presented with technical information which was not directly and unambiguously derivable from the application as filed.” The Board therefore concluded that claim 1 did not involve added matter. The appeal was dismissed, and the patent was maintained as granted. Conclusions This decision seems to be a softening of the EPO’s stance on assessing whether a claim amendment adds matter. Previously, it may have been more difficult to argue that features can be left out of a claim without the specification including an explicit reference to those features being optional, or being interchangeable with alternative features known to the skilled person. This decision implies that such an explicit statement is not needed if the skilled person would inherently know this. It will be interesting to see whether this decision is an outlier, or if future Boards will follow suit. The decision can be found here.

Charged Up: Are we missing the potential of domestic battery storage for the energy transition?

It’s accepted that batteries will play a more and more important role in managing electricity demand as we transition to a greater proportion of renewables, but have we been thinking about them in the wrong way? I read a fascinating article on using batteries to manage weather-dependent renewable yields. This appealed to the nerd in me and, importantly, it gave a different view on the use of batteries for standalone domestic use – without requiring homeowners to install local renewable generation. Some patent searching with the new AI-powered vector search in Patently showed in minutes these concepts have been around since the 1990s. However, I did find relatively few applications. Perhaps this is an area where more R&D is needed, and there’s space for a disruptive new entrant. The potential seems immense as battery technology advances. There’s a lot written about how batteries flatten the “duck curve” of solar power, storing excess energy from solar in the day and then delivering it at night. This makes perfect sense in California and other reliably sunny countries. But what about the UK, where our renewable energy is much less unreliable? Solar power plummets if it’s cloudy and wind can also vary hugely. There’s a reason for the cliché about British people discussing the weather. The crucial point made in the article was to suggest in the UK we look ahead and control the batteries to charge them in advance of an anticipated drop in renewable output. Weather forecasting has become highly accurate in a 24-hour window and is only set to improve. The key insight in the article was to look ahead and see that tomorrow will be cloudy so solar output will drop. In that case, rather than operate the battery to store excess from the home solar generation (there might well be none), charge the battery the night before, creating a demand for baseload and/or wind energy, typically the greenest energy mix. I thought this was a great idea, and it shows how domestic batteries are useful even without renewable generation on site. We now have smart tariffs and times when you are paid to reduce consumption in the UK. Price here is the signal of excess / not enough generation and a low price is heavily dependent on renewables pushing out more expensive forms of generation to reduce the marginal price. From Patently’s vector search, I found that weather dependent battery-charging with associated solar power have been proposed in patent applications some time ago (e.g. JP H04200245A from 1992), but the link between weather in the future and battery storage seems not have been considered often. Perhaps now it’s time has come. The existence of this old publication gives some freedom to use the concept free of the risk of patent infringement, but it does not mean that innovators in the field cannot protect their developments. With much of the world having to adjust to less reliable weather-dependent renewables, could domestic batteries be the way forward? In the UK there’s a push to install heat pumps, this shifts demand from gas to electricity. Might we adjust our thinking of domestic batteries to associate it with demand, smoothing peaks by charging in advance when renewable energy is more abundant?

Updated EPO Guidelines on AI – why US companies should encourage close collaboration between their US and European attorneys on AI patent applications

On 1 March 2024, the European Patent Office (EPO) updated its Guidelines for Examination regarding AI inventions. This included new wording relating to the sufficient disclosure of training data. Specifically, the new Guidelines state in F-III-3 that there may be insufficiency in the invention where “the mathematical methods and the training datasets are disclosed in insufficient detail to reproduce the technical effect over the whole range claimed. Such a lack of detail may result in a disclosure that is more like an invitation to a research programme”; and in G-II-3.3.1 that “the technical effect that a machine learning algorithm achieves may be readily apparent or established by explanations, mathematical proof, experimental data or the like. While mere allegations are not enough, comprehensive proof is not required either. If the technical effect is dependent on particular characteristics of the training dataset used, those characteristics that are required to reproduce the technical effect must be disclosed unless the skilled person can determine them without undue burden using common general knowledge. However, in general, there is no need to disclose the specific training dataset itself”. Since then, we have become aware of commentary from US practitioners suggesting that these updates introduce “ambiguity” to the disclosure requirements that will make US applicants unsure whether it is even worth filing AI related patent applications at the EPO. However, from a European patent attorney’s perspective, these new sections represent a relatively straightforward application of established EPO principles of sufficiency to AI inventions. For sufficiency, what matters is whether the skilled person, with their common general knowledge, has enough information to carry out the invention without undue burden (see e.g. F-III-1 of the Guidelines, as well as II-4.1 of the Case Law of the Boards of Appeal); this guidance has existed in the Guidelines since at least 2001 (see C-II-4.9 of the 2001 Guidelines). As applied to AI, the skilled person needs to know, or be able to determine without undue burden, the characteristics of the training data required to produce the technical effect. If the training data is standard, which it very often is, then not much will be needed, whereas if there is something special about the training data or how it is collected, then more detailed steps of data collection, or alternatively a publicly available dataset, should be provided. In our opinion, it therefore seems at least some of the suggested “ambiguity” in the new Guidelines may have more to do with a lack of familiarity with longstanding European patent practice, than with an inherent ambiguity in the update itself. Our conclusion is not that US companies should avoid filing in Europe, but that close collaboration between their European and US patent attorneys is to be encouraged to optimise the specification for both jurisdictions. With our experienced team of European and US patent attorneys working together, EIP is particularly well placed to help clients get the best protection possible for their AI inventions, globally.

Updates

T 0192/22 - Is a first medical use claim a magic bullet?

The EIP team was pleased to receive the BoA Decision on T 0197/22 earlier this month, providing the reasons for revocation of Translate Bio’s EP 3318248 B1 at the oral proceedings held in March, where we represented one of the Opponents. The p...

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T 0192/22 - Is a first medical use claim a magic bullet?

The EIP team was pleased to receive the BoA Decision on T 0197/22 earlier this month, providing the reasons for revocation of Translate Bio’s EP 3318248 B1 at the oral proceedings held in March, where we represented one of the Opponents. The p...

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