T 663/02 – G 1/07 Injection

The present case is one of the cases where the Board decided to await the outcome of referrals to the Enlarged Board (EBA). It is only after decisions G 1/04 and G 1/07 had been issued that the Board resumed its work, which explains that a “02” decision is issued in 2011 only, almost nine years after the revocation of the opposed patent by the opposition division (OD).

Claim 1 of the main request before the Board was identical with claim 1 as granted:

A method of imaging an artery in a region of interest in a patient using magnetic resonance imaging and a magnetic resonance contrast agent, the method containing the steps of:

injecting the magnetic resonance contrast agent into a vein remote from the artery;

monitoring the region of interest by using a series of magnetic resonance radio frequency pulses and measuring the response of the region of interest to the series of magnetic resonance radio frequency pulses;

detecting the arrival of the contrast agent in the region of interest by comparing the response of the region of interest to the series of magnetic resonance radio frequency pulses before injecting the contrast agent to the patient to the response of the region of interest to the series of magnetic resonance radio frequency pulses during or after injecting the contrast agent to the patient;

generating an imaging initiation signal after detecting the arrival of the contrast agent in the region of interest;

collecting magnetic resonance image data in a magnetic resonance imaging sequence in response to the imaging initiation signal, wherein the magnetic resonance image data which is representative of the central portion of k-space is collected at the beginning of the imaging sequence and the data which is representative of the periphery of k-space is collected thereafter; and

constructing an image of said artery, using the magnetic resonance image data, wherein the artery appears distinct from the adjacent veins and background tissue.

The decision is interesting because it is one of the first to deal with the new situation created by G 1/07 and does so in a very detailed and pedagogical manner, admittedly at the expense of conciseness.

Diagnostic methods practised on the human or animal body (A 53(c))

Opinion G 1/04 of the EBA

[3.1.1] In its opinion G 1/04 [5] the EBA stated that there was no reason to deviate from the established jurisprudence of the boards of appeal, according to which

“the method steps to be carried out when making a diagnosis as part of the medical treatment of humans or the veterinary treatment of animals for curative purposes include: (i) the examination phase involving the collection of data, (ii) the comparison of these data with standard values, (iii) the finding of any significant deviation, i.e. a symptom, during the comparison, and (iv) the attribution of the deviation to a particular clinical picture, i.e. the deductive medical or veterinary decision phase”.

In this context, the EBA considered the question

“whether the diagnostic methods referred to in A 52(4) EPC [1973] comprise only the deductive medical or veterinary decision phase consisting in attributing the detected deviation to a particular clinical picture, i.e. the diagnosis for curative purposes stricto sensu, or whether they are also meant to include one or more of the preceding steps related to examination, data gathering and comparison”.

The conclusion drawn by the EBA was that 

“The diagnostic methods referred to in A 52(4) EPC [1973] include the method step related to the deductive medical or veterinary decision phase, i.e. the diagnosis stricto sensu, representing a purely intellectual exercise” (Reasons, [7]).

Moreover, 

“in order that the subject-matter of a claim relating to a diagnostic method practised on the human or animal body falls under the prohibition of A 52(4) EPC [1973], the claim is to include (in view of A 84 EPC [1973]) the feature pertaining to the diagnosis for curative purposes as a purely intellectual exercise representing the deductive medical or veterinary decision phase …, as well as the features relating to … the preceding steps which are constitutive for making the diagnosis …, and … the specific interactions with the human or animal body which occur when carrying those out among said preceding steps which are of a technical nature …” (Reasons, [8]).

Present case

[3.1.2] In the present case, the method of claim 1 of the granted patent does not include the deductive medical or veterinary decision phase, i.e. the diagnosis stricto sensu. Rather, it only includes the preceding steps of gathering information which are constitutive for making the diagnosis (“monitoring …, detecting …, generating …, collecting …, constructing …”), and the specific interactions with the human or animal body (“injecting …”) which occur when carrying out said preceding steps.

[3.1.3] Therefore, the subject-matter of claim 1 of the granted patent does not constitute a diagnostic method practised on the human or animal body within the meaning of A 53(c).

Methods for treatment of the human or animal body by surgery (A 53(c))

Opinion G 1/04 of the EBA

[3.2.1] In its opinion G 1/04 [6.2.1] the EBA stated that

“Methods of surgery within the meaning of A 52(4) EPC [1973] include any physical interventions on the human or animal body in which maintaining the life and health of the subject is of paramount importance”.

Moreover, the EBA confirmed the established jurisprudence of the boards of appeal, according to which

“a method claim falls under the prohibition of A 52(4) EPC [1973] if it includes at least one feature defining a physical activity or action that constitutes a method step for treatment of the human or animal body by surgery or therapy”.

Therefore, the surgical or therapeutic nature of a method claim can be established by a single method step.

The EBA also considered the development of medicine with regard to diagnostic methods. In particular,

“technological advances penetrate human and veterinary medicine and the medical and veterinary profession. Today, and more than at any time before, technology is about to fundamentally alter how and by whom health care is administered, with the result that human and veterinary medicine is gradually being reshaped by technology. In a changing medical or veterinary environment brought about by technological progress, the need for reconsidering the relationship between medical or veterinary practitioners and non-medicinal support staff will become more pressing than ever before. This will have implications for the non-medicinal support staff in terms of profile and expansion in that a great variety of diagnostic and other information will have to be procured and gathered by these persons” (Reasons, [6.3]).

These considerations have a general character and, therefore, should not be limited to diagnostic methods only.

Decision G 1/07 of the EBA

[3.2.2] In its decision G 1/07 [3.3.6] the EBA held that the introduction of the exclusion of surgical methods from patentability (A 53(c)) derived from socio-ethical considerations and considerations of public health (“Medical and veterinary practitioners should be free to use their skills and knowledge of the best available treatments to achieve the utmost benefit for their patients uninhibited by any worry that some treatment might be covered by a patent”.

This is the ratio legis of the exclusion clause.

In the judgement of the EBA, the broad construction of the kind of interventions being of a surgical nature developed in decision T 182/90 (“any non-insignificant intervention performed on the structure of an organism by conservative (“closed, non-invasive”) procedures such as repositioning or by operative (invasive) procedures using instruments including endoscopy, puncture, injection, excision, opening of the bodily cavities and catheterisation”) should be considered “as being or having become overly broad when considering today’s technical reality” (Reasons, [3.4.2.1-2]).

It is noted that the explicit referral to the “today’s technical reality” shows a manifest parallelism with the considerations made in opinion G 1/04 6.3]) pointing to the importance of “technological advances”.

Moreover, the EBA again referred to the today’s technical reality with regard to the application of routine interventions in the medical field. In particular, the EBA held that

“Today, numerous and advanced technologies do exist in the medical field concerning the use of devices which in order to operate must in some way be connected to the patient. Methods for retrieving patient data useful for diagnosis may require administering an agent to the patient, potentially by an invasive step like by injection, in order to yield results or at least they yield better results when using such a step. Considering this technical reality, excluding from patentability also such methods as make use of in principle safe routine techniques, even when of invasive nature, appears to go beyond the purpose of the exclusion of treatments by surgery from patentability in the interest of public health” (Reasons, [3.4.2.2]).

Consistently with the criticism of T 182/90, the EBA held that the definition given in G 1/04 (“any physical intervention on the human or animal body …”; Reasons, [6.2.1]) also appeared too broad (Reasons, [3.4.2.2]).

Thus, the EBA consistently pleaded for a narrow construction. 

“Hence, a narrower understanding of what constitutes by its nature a “treatment by surgery” within the meaning of A 53(c) EPC is required” (Reasons, [3.4.2.3]).

The wording used by the EBA (“is required”) clearly underlines the necessity of a new definition consistent with the today’s technical reality in the medical field. Such a need was indeed already acknowledged in G 1/04 [6.3], as mentioned above.

In order to find elements of a narrower understanding, the EBA stated that

“any definition of the term “treatment by surgery” must cover the kind of interventions which represent the core of the medical profession’s activities, i.e. the kind of interventions for which their members are specifically trained and for which they assume a particular responsibility” (Reasons, [3.4.2.3]).

The used wording (“any definition … must …”) is categorical about the need of concentrating on the “core of the medical profession’s activities”.

The core referred to above concerns

“the physical interventions on the body which require professional medical skills to be carried out and which involve health risks even when carried out with the required medical professional care and expertise. It is in this area that the ratio legis of the provision to free the medical profession from constraints by patents comes into play. Such a narrower understanding rules out from the scope of the application of the exclusion clause uncritical methods involving only a minor intervention and no substantial health risks, when carried out with the required care and skill, while still adequately protecting the medical profession” (Reasons, [3.4.2.3]).

In this statement, the concepts of “professional medical skills”, “medical professional care and expertise”, “health risks” and “substantial health risks” are introduced as criteria which help in differentiating between major physical interventions on the body to be excluded from patentability and uncritical methods for which the exclusion clause should not apply.

Further criteria may be the “degree of invasiveness” or the “complexity of the operation performed” (“the required medical expertise and the health risk involved may not be the only criteria which may be used to determine that a claimed method actually is a “treatment by surgery” within the meaning of A 53(c). The referring decision and the President have mentioned the degree of invasiveness or the complexity of the operation performed …”; Reasons [3.4.2.4])

With regard to health risks, the EBA also considered the potentially negative side effects of the administration of diagnostic contrast agents. In this respect, it was clarified that

“there is an exclusion from patentability as a surgical method only if the health risk is associated with the mode of administration and not solely with the agent as such” (Reasons, [3.4.2.3]).

Present case

[3.2.3] The question to be decided in the present case concerns whether, in the context of claim 1 of the granted patent concerning a method of imaging an artery in a region of interest in a patient using magnetic resonance imaging and a magnetic resonance contrast agent, the step of “injecting the magnetic resonance contrast agent into a vein remote from the artery” has a surgical character. According to the granted patent, this step implies the placement of an intravenous catheter through which the contrast agent may then flow into the vascular system. It may here be left open whether the injecting action stricto sensu, i.e. pumping the contrast agent into the vein, immediately follows or not the placement of the catheter.

It is not for the Board to develop a new narrow construction of what should be regarded as surgical activities excluded from patentability. This would indeed exceed the limits of the present case. Rather, the Board has to judge on the applicability of the exclusion clause to the present method claim in the light of G 1/04 and G 1/07 referred to above. If the step mentioned above is considered as surgical, the claimed imaging method including this step would then fall under the prohibition of A 53(c) as a method for treatment of the human or animal body by surgery (G 1/04).

Core of the medical profession’s activities

[3.2.4] The EBA explicitly held in G 1/07 that “any” narrower definition of treatment by surgery “must” cover the interventions which represent the “core of the medical profession' activities”. Thus, it has to be assessed whether the injection of a magnetic resonance contrast agent into a vein belongs to the said core. This assessment should be made in the light of the technical development mentioned by the EBA. In particular, technology is today about to fundamentally alter human medicine, in particular how and by whom medical care is administered (G 1/04).

As a matter of fact, the placement of an intravenous catheter is one of the most common invasive procedures performed in hospitals and consulting rooms. Physicians are traditionally responsible for this intervention. But the increasing qualification level of paramedical professionals (the term “paramedical” is used as relating to professions which supplement and support medical work but do not require the level of a fully qualified doctor) has led to the adoption in national healthcare systems of regulations allowing physicians to delegate some activities which were in the past of their exclusive pertinence. This trend appears to reflect social changes like the higher life expectancy, the increasing demand for health services and the need to contain health costs.

For instance, in a current home healthcare system a nurse provides individualized care for patients in their own home following a hospital stay or for long-term care patients. The nurse is thus responsible for carrying out a therapy at home if necessary, which may include the administration of drugs prescribed by a physician through a peripheral venous access. This requires from the nurse adequate levels of training, expertise and experience.

Moreover, the increasing qualification level of paramedical professionals has led to the development of new professions like, for example, that of radiographers meanwhile officially acknowledged in the United Kingdom. A radiographer is a radiologic technologist who assists a radiologist, i.e. a physician specialised in radiology, in the practice of the medical profession. For example, a diagnostic radiographer interacts with patients and supervises the appropriate radiographic techniques to be used for obtaining the images required by the delegating radiologist. As a matter of fact, a duly trained and qualified radiographer may be delegated to make intravenous injections of a contrast agent when carrying out a magnetic resonance imaging procedure. This happens under the supervision of the delegating radiologist.

Therefore, it appears that in current healthcare systems a physician may delegate medical acts, for example intravenous injections, to paramedical professionals duly trained and qualified for carrying out the delegated act. The delegation is governed by regulations which may differ depending on the national healthcare systems. These regulations define all the acts which may be delegated. Alternatively, they establish the criteria which have to be met for the delegation to be possible and the limits which have to be respected. The delegating physician usually evaluates the risks to the patient, delegates only those acts for which a paramedical professional has been specifically trained, and supervises the work of the delegated professional. De facto, qualified hospital nurses are today entrusted with taking venous blood probes, giving infusions and making intravenous injections.

In view of this development, delegated acts can hardly be considered as belonging to the core of medical activities. As already stated, current regulations, in the interest of an efficient service to the patients, allow a physician to delegate minor interventions which do not imply substantial health risks, when carried out by a qualified paramedical professional with due care and skill. Delegation does not apply to the core of the medical activities which, within the meaning of G 1/07, cover the physical interventions which involve substantial health risks even when carried out with the required medical professional care and expertise and for which the physician assumes particular responsibility.

In summary, an intravenous injection can today be delegated by a physician to a qualified paramedical professional. This gives an indirect hint at the fact that such an injection may be considered as representing a minor routine intervention which does not imply substantial health risks when carried out with the required care and skill. It thus follows that the step of intravenously injecting a contrast agent would be ruled out from the scope of the application of the exclusion clause (A 53(c)) following the narrow understanding advocated by the EBA (G 1/07).

Substantial health risks

[3.2.5] In the following, it is worth to try assessing the health risks of intravenous injections with the aim of verifying whether the indirect hint mentioned above can also be derived in a direct way.

Known complications of intravenous injections are infection, phlebitis, extravasation, bleeding and haematoma.

An effective way of assessing risks is to use a so-called risk matrix. The likelihood that a complication of an intravenous injection may happen is represented on a first scale (x-axis). The health impact of that complication is represented on a second scale (y-axis). According to a simple model, the likelihood is subdivided in three levels, i.e. “unlikely”, “likely” and “very likely”. The health impact is also subdivided in three levels, i.e. “minor”, “moderate” and “major”, wherein “minor” would cover negligible effects which do not need any treatment, “moderate” reversible effects which can be easily treated, and “major” serious irreversible effects or even death. The risk matrix thus permits to combine the levels of likelihood and health impact of a complication with regard to a large number of patients so as to obtain statistical health risk scores which may be used to decide what action should be taken, for instance whether or not the intravenous injection may be delegated to a paramedical professional.

Due to its definition, the risk matrix is subdivided in various sectors. A first sector is defined by the levels “unlikely” and “minor”, a second sector by the levels “likely” and “minor”, and so on up to the last sector corresponding to the levels “very likely” and “major”. The heath risk score assigned to each sector increases when moving from the first to the last one.

In the Board’s view, such an assessment based on the risk matrix would be in agreement with the understanding of the EBA (G 1/07) in that the sectors with low health risk scores, at least that with the levels “unlikely” and “minor”, would correspond to the uncritical methods involving only a minor intervention and no substantial health risks and the sectors with high health risk scores, at least that with the levels “very likely” and “major”, would correspond to the physical interventions on the body which require professional medical skills to be carried out, which involve substantial health risks even when carried out with the required medical professional care and expertise, and for which the physicians assume a particular responsibility.

In the present case, there should be no doubt that all the complications of intravenous injections mentioned above are reversible and can be solved with standard treatments, if necessary. Thus, the above risk assessment gives a further direct hint at the fact that intravenous injections may be considered as minor routine interventions involving no substantial health risks.

During the appeal proceedings, a serious complication of intravenous injections of a specific magnetic resonance contrast agent was mentioned. Patients with acute or chronic renal insufficiency who receive a gadolinium-based contrast agent appear to be at an increased risk for developing a Nephrogenic Systemic Fibrosis (NSF). This complication, however, only depends on the injected substance.

As a further complication, allergic reactions may be mentioned which also depend on the injected substance.

In this respect, the EBA clarified in G 1/07 that there was an exclusion from patentability as a surgical method only if the health risk was associated with the mode of administration and not solely with the agent as such. Therefore, the complications concerning NSF and allergies are irrelevant for the issue of assessing whether the claimed method should be excluded from patentability under A 53(c).

Degree of invasiveness and complexity of the operation performed

[3.2.6] The Board holds that an intravenous injection is an invasive intervention. However, the degree of invasiveness and the complexity may be considered as being low, at least with regard to injections into superficial arm or leg veins, as it is envisaged in the patent in suit.

Therefore, even considering these criteria, the same conclusions mentioned above could be drawn.

[3.2.7] Therefore, it results from the foregoing that the method according to claims 1-11 of the granted patent does not relate to a method for treatment of the human or animal body by surgery falling under the prohibition of A 53(c). This conclusion is consistent with G 1/07.

The Board found the main request to be allowable and ordered the patent to be maintained as granted.

To download the whole decision, click here. The file wrapper can be found here.

An earlier decision implementing G 1/04 and G 1/07can be found here.

T 823/07 – Logorrhoea

The present decision deals with an appeal filed by the applicant after the Examining Division (ED) had refused its application.

Claim 1 of the main request before the Board read:

1. Searching apparatus configured to identify commercial suppliers (111, 112, 113) in response to a specified keyword, the apparatus comprising:

• input means arranged to receive an input keyword;
• searching means (401) configured to search a database (402) indexed with respect to specified keywords to identify displayable text items related to said input keyword, each item regarding one of said commercial suppliers (111, 112, 113);
• image storage means (405) arranged to store graphical images, each graphical image identifying or being associated with a commercial supplier (111, 112, 113);
• linking means configured to link each stored graphical image with a respective one of the displayable text items to form a respective stored results entry, the stored results entry in use being arranged to present the text item and graphical image for simultaneous display; and
• output means (403) configured to supply data defining a displayable list of said stored results entries assembled by said linking means, thereby enabling a user to identify a desired commercial supplier from the list of stored results entries when the list is displayed, based upon the graphical image of each stored results entry.

In what follows the Board discusses the presence of an inventive step with respect to document D1.

[4] It is uncontroversial that the invention claimed is distinguished from the search engine of document D1 in that

(A) the images stored by the image storage means identify or are associated with commercial suppliers;

(B) the linking means links such images, i.e. images which identify or which are associated with commercial suppliers, with the corresponding text item to form listings (stored results entries) to display each text item and corresponding graphical image simultaneously;

(C) so that when the listings are displayed the user is enabled to readily identify a desired commercial supplier from the graphical image.

[5] These features, however, derive in a straightforward manner from an underlying concept which lacks technical character and does thus not provide a technical contribution to the prior art.

In fact, displaying logos of commercial suppliers in combination with information concerning products, services etc provided by such suppliers is a presentation of information which exclusively addresses the mental and cognitive activities of users. There is no direct causal relationship to the technical solution of a technical problem. Even if it is true that presenting information according to this concept enables the user to identify the desired supplier and the associated listings more easily and quickly than with the prior art system, this result would be entirely subjective depending on the mental furniture of the user.

[6] As follows from decision T 1143/06 [5.4], the manner how cognitive content is presented to the user may only contribute to the technical solution of a technical problem if the manner of presentation (exceptionally) shows a credible technical effect. Non-technical features and aspects of an invention should not be given any weight in assessing inventive step. If they belong to the general framework in which the invention evolves, they may be used in formulating the relevant technical problem (see decision T 641/00).

[7] There has been no proof of any such technical effect of the present concept of presenting information, beyond the alleged advantages which concern the mental and cognitive activities of the user. The only credible technical effects result from the computer implementation of this concept.

This circumstance distinguishes the case from the decisions cited by the appellant in support of its arguments […]. In all these decisions, the board concluded on the existence of a technical contribution over the prior art. The technical contribution resulted from overcoming physical limitations of the size and resolution of computer screens (T 643/00, T 928/03) and from the functions of a “new input device” conferring technical character (T 333/95). Neither one of the decisions derives the technical character of a feature or activity from the mental effort required or any similar effect; these are only secondary considerations. Moreover, in the context of inventive step, caution is required in applying old decisions concerning non-technical subject-matter like decision T 333/95 since the relevant case law has experienced some important development as explained in decision T 154/04 […].

In the present case, the only relevant technical aspects of the invention are standard programming features for implementing the idea of displaying search results in connection with supplier logos on a computer system. The programming and implementation of this idea is obvious in the light of the prior art.

[8] In fact, document D1 already indicates that “[if] some other graphic is to be displayed, then the name of that graphics image format file is entered into this field” […].

Striving to solve the technical problem of providing the search engine of document D1 with the additional functionality of combining individual logos of commercial suppliers with the associated search results, a skilled person would immediately recognise from document D1, figure 17 that merely the name in field 1750 had to be changed from pointing to a more or less fixed graphic (bullet) to a logo associated with the commercial supplier identified in name field 1705.

There are no technical difficulties to overcome in providing an image database of commercial supplier logos and establishing an appropriate cross reference to the said name fields 1705 and 1750 of the data stored in the yellow pages database 245 of the prior art system.

[9] For these reasons, the invention according to claim 1 of the main request does not meet the requirement of inventive step.

To read the whole decision, click here. The file wrapper can be found here.

Oldies But Goldies - Proof For Prior Use

As new decisions are scarce these days, I have decided to follow a suggestion that a member of the Boards has made to me not long ago. It is an idea I had had in the past but which I had never reduced to practice because back then I was snowed under with fresh decisions. The idea is to present old decisions which are still cited today but which not all of those who cite them have actually read. So, from time to time, I shall present key passages of such decisions. Feel free to let me know whether you like the idea or not.

Of course, there are some risks in presenting old case law, because the EPC has changed here and there and some statements may simply be obsolete. Also, my knowledge of case law is limited and I might miss relevant decisions. Should I fall into one of those traps, please leave a comment.

I have decided to start with decisions mentioned in my previous post – decisions that deal with prior use and the standard of proof required for establishing the reality of such a use.

T 270/90 is a relatively early decision (March 21, 1991) of Board 3.3.3 tackling the question of which standard is to be applied. The Board nicely summarised the “balance of probability” principle developed in earlier decisions (e.g. T 381/87 and T 182/89) and then applied it to prior uses:

[2] [… T]he objection of lack of novelty boils down to an objection of prior public use based on the analytical results of Noryl samples submitted by the [opponents].

[2.1] In relation to the issue of prior use the [patent proprietor] strongly argued that, as a matter of law, this ground of objection needed to be proved more strictly than any of the other grounds of objection available under A 100. Indeed, he went so far as to say that the evidential test for establishing prior use under the EPC must be at least as strict as the strictest of tests applied by any of the relevant judicial organs of the Contracting States. In effect, he submitted that prior use had to be established not on the balance of probability but beyond reasonable doubt, that is to say established with the same degree of strictness as applies, for example, to criminal proceedings in the United Kingdom.

The Board wishes to restate the principles of law that apply to appeal proceedings under the EPC, for these principles are tacitly assumed in many cases, but are seldom expressly spelt out.

The Boards of Appeal are judicial bodies, adjudicating, in the case of oppositions, in contentious civil matters. The matters are contentious because there is an opposition to a granted patent, and they are civil because they pertain to a species of intellectual property. Although it is true that the Boards are possessed of inquisitorial powers (A 114(1)), these powers do not convert them from judicial into administrative tribunals.

In consequence, when arriving at their decisions, the Boards, in addition to exercising their inquisitorial powers (should this be necessary), decide the issues before them on the basis of the evidence adduced by the parties. Their decision need not, and indeed in most cases could not, be based on absolute conviction, but has, instead, to be arrived at on the basis of the overall balance of probability, in other words, on the footing that one set of facts is more likely to be true than the other (see decision T 182/89).

As far as each of the parties to the proceedings is concerned, they carry the separate burdens of proof of any fact they allege. The weight of that burden is the balance of probability as distinct from “beyond all reasonable doubt” or “absolute conviction”. In the course of an appeal, therefore, each party must seek to prove facts alleged by it to this degree of proof and, as was said above, it is the function of the Board to decide, applying the same standard, which set of facts is more likely than the other to be true.

These principles clearly apply to all facts and matters alleged in relation to all grounds of opposition, including public prior use. Accordingly, the [patent proprietor’s] submission that the evidential test or burden of proof for prior public use needs to be stricter than that for other grounds of objection under the EPC is rejected.

[…]

In T 472/92 (November 20, 1996) the same Board introduced a caveat with respect to this approach:

[3.1] Concerning the standard of proof that needs to be applied, the established legal practice of the Boards is to use the self-same standard of proof in prior public use objections as it does in others covered by A 100 : the balance of probability (see, e.g. T 270/90). In that case, the Board expressly refused to accept a submission that the much more rigorous standard of “beyond all reasonable doubt” should apply, even if, as was the case there, both parties were able to access and to adduce evidence relating to the decisive issue of confidentiality of the transactions alleged to constitute prior public use.

The Board reaffirms this approach, subject to the following caveat. Deciding any fact at issue by applying the above standard requires making a choice as to which one of the two contradictory propositions espoused by the parties is more likely to be true, since two contradictory propositions cannot, in logic and therefore in law, be either true or false. In judging the truth or falsity of either, regard must be had to the nature, content and likely source of the evidence that is available and can be adduced by the parties.

Generally speaking, in cases not involving the issue of prior public use, both parties are able to obtain and to adduce the evidence upon which their respective case rests. By contrast, in the majority of prior public use cases practically all the evidence in support of an alleged prior public use lies within the power and knowledge of the opponent, so the patentee seldom has any ready, or indeed any access to it at all. All he can, in practice, do is to challenge that evidence by pointing out any inconsistencies contained in it or to draw attention to any gaps in the chain of commercial transactions that needs to be established by the opponent in order to succeed on this ground.

In consequence, an opponent must prove his case up to the hilt, for little if any evidence will be available to the patentee to establish the contradictory proposition that no prior public use had taken place.

[…]

In February 2003, Board 3.5.01 issued decision T 55/01 where it found an exception to the exception:

[4.1] […] It is true that, in cases where only one party has access to information about an alleged public prior use, the case law has tended towards expecting that the public prior use be proved beyond any reasonable doubt (“up to the hilt”), answering the typical questions “What?”, “When?”, “Where?”, “How?” and “To whom?”, since the other party was reduced to merely pointing out inconsistencies or gaps in the chain of evidence; see T 472/92 [3.1]. The case law has however taken into account that cases of mass-produced consumer goods which are widely advertised and offered for sale to customers who often remain anonymous may require different treatment; see T 241/99 [4.2]. Indeed, to demand a complete chain of proof in such cases would make it unreasonably complicated for a party to successfully rely on a sale or an offer for sale to prove public availability. […]

I’ve had a look at T 241/99 (December 6, 2001; Board 3.5.2 ; in German). Here is my translation of the most relevant paragraphs:

[4.1] As correctly noted by opponent 02, according to the case law, one single proven sale is sufficient for making the sold object available to the public (T 482/89 [3]).

However, the Board is of the opinion that in such a case the requirements of R 55 c) [EPC 1973] would only be complied with if the name and the address of the single buyer were given within the time limit for filing an opposition. The Board does not see any difference between the indication “client X” and the absence of any indication with respect to the client.

[4.2] [Opponent] 02 insisted that the situation was to be assessed differently when there were sales to a plurality of clients, as in the present case. It is indisputable that sales on a market place or over the counter are to be assessed differently as regards the indication of facts and evidence than the case of a single sale; however, the Board is of the opinion that the present case does not belong to this kind of sale of bulk goods (Massenware) to anonymous clients. […]

If I understand things correctly, this obiter dictum from T 241/99 does not contradict T 472/92. It does not say that in a case where all the evidence in support of an alleged prior public use of bulk goods lies within the power and knowledge of the opponent, the balance of probabilities should be applied, but that the indication of facts and evidence should be assessed differently. When putting together T 472/92 and T 241/99, I would come to the conclusion that the standard of proof is still “up to the hilt” but that “up to the hilt” can mean something different when mass sales are considered. To be more precise, in order to establish beyond reasonable doubt that such a sale has taken place, you would not have to provide the names of the buyers, but other evidence as to the reality of the sale would do. Therefore, I am not sure that T 55/01 has really drawn the right conclusion from T 241/99.

Of course, there is much more case law out there and the doctrine of the Boards is not as clear-cut as might appear from this presentation. Your personal conclusions might also differ from mine. Be that as it may, I think these three decisions are well worth reading again.

T 278/09 – On Sheets And Other Paperwork

The present appeal was directed against the decision of the Opposition Division (OD) revoking the opposed patent.

The decision contains an interesting discussion of whether some of the documents cited against the patent were indeed available to the public before the priority date of the patent under consideration (1/9/99).

It shows how hard it can be for an opponent to prove the existence of a prior public use/disclosure.

*** Translated from the German ***

[1.3.1] Document D2 is a product specification sheet issued by Engelhard Corporation describing the product Biju® BVW. This document has at its bottom left a so-called revision date REV-3 from 1994. There is no date of impression or publication.

D2 - click to enlarge

It can be seen from the declaration of Mr Ozimek, filed as document D15, that Mr Ozimek has been working in the pigment distribution business for Mearl Corporation (from 1994 to 1996), for Engelhard Corporation, which had merged with Mearl Corporation (from 1996 to 2006) and for BASF Corporation, which has merged with Engelhard Corporation (since 2006). […]

NB: BASF Corporation acts as opponent in the present case.

According to this declaration the product Biju® BVW was sold by Mearl Corporation from 1994 to 1996; it was only from 1997 onwards that the product was sold by Engelhard Corporation. […]

Moreover, document D15 contains the declaration that product specification sheets were sent to the clients on the date of revision indicated at their bottom left, or shortly afterwards. […] However, document D15 does not mention whether the specific product specification sheet D2 was transmitted to the clients without any obligation of secrecy and whether this version has been made available to the clients at all.

The Board also notes that document D2 of Engelhard Corporation could not have been sent to the clients on the mentioned revision date of 1994 or shortly afterwards because, as can be seen from document D15, Engelhard Corporation only could sell the Biju® BVW product from 1997 onwards, after its merger with Mearl Corporation. Moreover, it is unknown whether the original revised version of 1994 – which has not been filed – was made available to the clients by the then product proprietor Mearl Corporation without any obligation of secrecy, or has been sent to the clients at all.

Furthermore, the statement in document D15 according to which the product Biju® BVW was sold, without there being any evidence for a sale to a buyer who was not bound by an obligation of secrecy, is insufficient as proof for a prior public use (see T 472/92 [3.1-2] and “Case Law of the Boards of appeal of the EPO”, 6th edition, 2010, I.C.1.8.8(a), page 76) or public availability of document D2. Moreover, the indications, which are provided below the product properties in D2 only indicate that the product described therein was only potentially intended to be sold but do not provide proof that a product having the disclosed properties has indeed been sold without any obligation of secrecy.

In this context, the Board is of the opinion that a product specification sheet only presents the composition and the properties of newly developed or improved products and as such does not reveal anything on its commercialisation and potential public availability. The decision on commercialisation and on the moment of commercialisation can be based on other circumstances, such as the general economic situation or the commercialisation policy of the company under consideration. Moreover, the positive decision to commercialise a product does not necessarily entail that a product specification sheet is to be made available to the public, because it can also be distributed under obligation of secrecy. Therefore, in such a case it is not sufficient to merely strike the balance of probabilities for the public availability of an allegedly novelty destructive product specification sheet, the public availability of which is only based on presumptions (see also T 738/04 [3.4]).

[1.3.2] Document D13 of Mearl Corporation also concerns the product Biju® BVW and has a revision date 2/18/93, i.e. of 1993.

D13 - click to enlarge

As Mr Oziek was not yet working for Mearl Corporation in 1993 […] his declaration is irrelevant in respect of the availability of document D13.

Document D13 contains a barely readable passage with three signatures at its bottom right. Therefore, it is not clear to the Board whether this document is an internal document of Mearl Corporation or a product specification sheet to be given to clients. Moreover, it is unknown whether this document was indeed made available to clients without there being any obligation of secrecy and whether it has been sent to the clients at all.

The arguments made in respect of document D2 also apply to document D13 in an analogous way.

[1.3.3] As far as the decisions T 804/05, T 743/89 and T 55/01 are concerned, the Board is of the following opinion:

• Decision T 804/05 dealt with the public availability of an advertising leaflet, which is normally distributed among interested circles and which has a date on its cover sheet; the competent Board decided that in the absence of proof to the contrary one had to presume that the advertising leaflet had been made available to interested clients without any obligation of secrecy during the months following this date (see point [2] of the reasons). However, this case differs from the present case because a loose product specification sheet, which is not part of an official advertising leaflet, does not, as explained above, necessarily qualify as information that is meant for the public;

• T 743/89 concerned a commercial flyer which was normally to be distributed among interested circles and which had a date (see point [3] of the reasons); in this case also it was decided that one had to presume that the flyer was made available to the public during the months following the date of impression. Therefore, this case is not to be equated with the present case, where the Board has to decide on the public availability of a loose product specification sheet without any date of impression, which is not part of an official advertising leaflet and does not necessarily qualify as information that is meant for the public;

• T 55/01 dealt with the question of whether an operating manual for the satellite receiver of certain TV set brands, which had a date of impression, had been made available to the public. The competent Board decided (see point [4.1] of the reasons) that TV sets were mass-produced goods that were distributed on the market very quickly in order to be sold or retailed. As they are certainly sold or retailed very quickly, they are to be considered as having been made available to the public even if there is no specific proof for a sale. Therefore, the operating manual that was delivered together with a TV set had to be offered for sale during the months following the date of impression, and, as a consequence, had been made available to the public. This case is not to be equated with the present case either because pigment mixtures cannot be considered to be mass products.

[1.3.4] Therefore, the Board comes to the conclusion that there is no proof whatsoever that the documents D2 and D13 and the product disclosed therein had been publicly available before the priority date or the filing date of the impugned patent.

[1.3.5] The documents D8a, D8b and D8d are product specification sheets of the products Biju® Ultra UXD of the BASF Corporation, Timica Extra Large Sparkle Product No. 110S of the Mearl Corporation and Suspending Lacquer SLF-2 of the Mearl Corporation.

Document D8a of the BASF company has a revision date Rev.3 (3/7/95) of 1995 and another date of 2007. Thus there is no doubt that this document is not part of the state of the art.

D8a - click to enlarge

Although document D15 explains in point 9 that the product Biju® Ultra UXD was sold by the Mearl corporation and the Engelhard corporation between 1994 and 1999, there is no evidence that a product specification sheet with the features listed in document D8a was indeed made available to the clients during this period without any obligation of secrecy, or that the original revised version of 1995 – which has not been filed – had been made available to the clients of the then product proprietor, the Mearl corporation, without any obligation of secrecy or had been sent to the clients at all.

The product specification sheets D8b and D8d have the dates 10/81 and 3/87 and 11/85, respectively, which point towards periods before 1990. Therefore, the declaration of Mr Ozimek, who had only been hired by the Mearl company in 1994, are irrelevant in respect of those documents.

D8b - click to enlarge

D8d - click to enlarge

Moreover, the word “obsolete”, which means “out-dated”, has been stamped on those sheets. Although the [opponent] has declared during the oral proceedings that the word was stamped by the BASF corporation, i.e. after 2006, in order to mark products that were not commercialised any more, there is no evidence whatsoever that this had not been done by the previous product proprietors and that those sheets have been made available to the clients without any obligation of secrecy, or had been sent to the clients at all.

The further arguments made above in respect of documents D2 and D13 also apply to those documents in an analogous way.

[1.3.6] As it has not been proven that documents D2, D8a, D8b, D8d and D13 were available to the public before the priority date or the filing date of the impugned patent, these documents are not to be taken into account any more.

The Board then found the main request to be novel and remitted the case to the OD for further prosecution.

I may be wrong but I think that the Board should have mentioned one important fact:

In the present case, the alleged prior use/disclosure was made by the opponent company itself, which means that the facts have to be proven “up to the hilt”. As a matter of fact, T 472/92, which is cited in the present decision, has established that

“[a]lthough the standard of proof is the same for all objections covered by A 100 (cf. T 270/90), in those prior public use cases, where practically all the evidence in support of an alleged prior public use lies within the power and knowledge of the opponent, the latter has to prove his case up to the hilt.”

In T 804/05 the advertising leaflet was issued by Italian company Kariba S.p.a, which had no apparent link with the opponent, Italian company Crevan.

In T 743/89, the flyer was issued by Borg-Warner Chemicals Inc.; the opposition was filed by Ciba-Geigy.

Finally, in T 55/01, the opposition was filed by Interessengemeinschaft für Rundfunkschutzrechte GmbH; the operating manual was sold by the Metz company.

So in all those cases, the standard to be applied was the balance of probabilities, whereas in the present case, the more strict “up to the hilt” standard is appropriate. For this reason alone, the cited decisions are not relevant and the Board’s arguments concerning the different nature of flyers and product specification sheets etc. appear to be unnecessary.

To download the whole decision (in German), click here.

The file wrapper can be found here.

T 126/09 – Selected With Care

This decision deals with the refusal of an application by the Examining Division (ED), on the ground of lack of novelty with respect to document D4.

Claim 1 before the Board read (in English translation):

Arrangement for carrying out surgical laser treatments of the cornea, the arrangement being adapted to emit pulsed treatment radiation with a wavelength of between 340 nm and 360 nm and a pulse duration in the femtosecond range, wherein the pulse energy of the treatment radiation is between 0.1 nJ and 5 μJ, preferably at most about 10 nJ.

Here is the outcome of the novelty assessment by the Board:

*** Translated from the German ***

[3.1] D4 primarily deals with the determination of the fluence threshold for the fluence threshold for the optical breakdown and the determination of a point at which there is a change of the characteristic curve describing the fluence threshold as a function of laser pulse width for a variety of materials to which laser radiation is applied […]. The lasers used to this aim generally also work in the femtosecond range, with pulse energies that are within the domain cited in claim 1 […]. In the second paragraph of column 3 the wavelength range from 200 to 1000 nm is cited.

Under “Example 3” […] the (in vitro) examination of cornea tissue with a wavelength if 770 nm is also disclosed. D4 does not mention any reasons for the choice of the wavelength value, nor does it refer to other wavelengths [suitable] for this material.

[3.2] Thus the subject-matter of claim 1 differs from D4 only by the claimed wavelength range between 340 and 360 nm.

[3.3] Therefore, the distinguishing feature concerns the selection of a sub-range within the broader parameter range disclosed in D4. As far as the assessment of novelty is concerned, the established case law of the Boards of appeal (see, e.g. T 198/84) requires that the following criteria be taken into consideration: the selected sub-range has to be (a) narrow, which is doubtlessly the case here (20 nm) and (b) sufficiently far removed from the known boundary values and examples, respectively, which is also the case here. Finally, it must (c) not be an arbitrary selection without there being a new technical teaching. This criterion is also fulfilled here, for the following reasons:

On the one hand, the lower limit of the selected wavelength range ensures that the treatment radiation penetrates deep enough into the cornea (as a rule, the shorter the wavelength, the lower the penetration depth; the cornea becomes significantly transmissive at about 300 nm). On the other hand, the upper limit avoids the radiation to have undesirable secondary effects on other tissues of the eye, in particular the retina […]. In this context it is important to consider the transmissivity of the lens under the cornea, which significantly increases below about 400 nm, so that radiation of greater wavelength can reach the rear parts of the eye, as far as the retina, almost without being attenuated (mehr oder weniger ungehindert), and can damage them. The selected (narrow) wavelength range from 340 to 360 nm is sufficiently remote from both limits (300 and 400 nm, respectively) so as to allow for patient specific variations of those limits of transmissivity.

[3.4] The technical effect related to the upper boundary value cannot be considered to be “speculative” (as stated in point [1.3] of the decision refusing the application) because it can be clearly seen from the relevant technical literature that the transmissivity of the human eye lens significantly increases above 400 nm.

It is further clear from point [1.4] of the decision refusing the application that the ED considered it mandatory that said technical effects were found in the selected sub-range exclusively. However, the Guidelines for examinations cited in this context (C-IV 9.8, version December 2007) only make the (positive) statement that criterion (c) is met if the technical effect occurring in the selected sub-range does not occur in the whole of the known range (see also T 198/84 [7]). This does not allow to derive the requirement construed by the ED. As correctly stated in the statement of grounds of appeal […], such a requirement would hardly ever be met and is, therefore, out of touch with reality (realitätsfremd).

[3.5] Thus the claimed wavelength range is not an arbitrary cut-out of the range known from D4 and, therefore, not lacking novelty. Under these circumstances, it may remain open whether the lasers mentioned in general terms in D4 are “arrangements for carrying out surgical laser treatments of the cornea” within the meaning of claim 1.

[3.6] As none of the other documents of the state of the art discloses the claimed combination of features, the subject-matter of claim 1 is novel within the meaning of A 54(1) and (2).

To read the whole decision (in German), click here.

The file wrapper can be found here.

T 394/10 – No Shortcuts Please

When applicants respond to a notification under R 71(3) by amending what the Examining Division (ED) was ready to grant, they sometimes invite trouble.

In the present case the ED sent a communication under R 71(3) wherein it proposed two amendments : one in the description (where the term “preferably” was to be deleted in one paragraph) and another in claim 1 (where “is chosen from” (“man ... wählt aus ...”) was replaced by “consists of” (“... aus ... besteht”)).

In its reply the applicant requested the correction of an orthographic error and stated that the amendments proposed were not appropriate, in particular because the term “consists” led to an undue limitation of the finish (1) whereas the original expression was open. It therefore requested the patent to be granted without the proposed amendments (main request).

The applicant also filed two auxiliary requests :

• Auxiliary request 1: claims as proposed by the ED, plus an additional feature intended to “open” claim 1 as amended (“wherein the finish (1) may also comprise …”)
• Auxiliary request 2: claims as proposed in the communication under R 71(3).

The ED granted the patent according to auxiliary request 1 (NB: the English and French translations published in the B1 document correspond to the main request).

The applicant filed an appeal and pointed out that the ED had not given any reasons for refusing the main request.

The Board finds this complaint to be justified:

*** Translation from the German ***

[2] Pursuant to A 113(2) the EPO shall examine, and decide upon, the EP application or the EP only in the text submitted to it, or agreed, by the applicant or the proprietor of the patent. In order to ensure [compliance with] this [provision], pursuant to R 71(3), the ED informs the applicant of the text in which it intends to grant it before it decides to grant the patent. This text may include amendments and corrections made by the ED on its own initiative which it can reasonably expect the applicant to accept (Guidelines for examination in the EPO, C-VI 14.1) Pursuant to A 113(2), such an amended version may only be adopted as a basis for the decision if it has been approved by the applicant. This is also explained in the Guidelines E-X 3.

In the present case the applicant has clearly stated that it did not approve the proposed version and has insisted on its original request. Moreover, it has filed two auxiliary requests.

[3] When a main and further auxiliary requests are filed, then [the ED] has to examine the main request first and then the auxiliary requests, in the order given by the applicant. If the ED considers an auxiliary request to be allowable, then it has to inform the applicant and to provide reasons why the higher ranking request(s) cannot be allowed. This way of proceeding is stipulated both in Legal Advice n° 15/05 and in the Guidelines (C-VI 4.1) and is based on the case law of the Boards of appeal (T 1181/04, T 1255/04). It is also to be applied when a main and auxiliary requests are filed in response to a communication pursuant to R 71(3).

[4] The main request filed by the applicant contains an amendment with respect to the version according to the communication pursuant to R 71(3). The applicant has filed translations of the claims of its main request and paid the fees for grant and publication within the time limit under R 71(3). According to R 71(4), it is, therefore, deemed to have approved the grant of the patent as amended. As a consequence, the ED was entitled to immediately grant a patent on the basis of this request alone. If the ED did not consent to the amendments, then, pursuant to R 71(5), it has to give the applicant an opportunity to comment before taking a decision. However, it has not done so.

[5] Therefore, R 71(5) has been violated. At the same time, there has been a violation of A 113(2) because the ED has granted a patent without asking the applicant for its approval beforehand. As a consequence, there have been two substantial procedural violations justifying a reimbursement of the appeal fee pursuant to R 103(1)(a). […]

The case is remitted to the first instance for further prosecution.

To read the whole decision (in German), click here.

The file wrapper can be found here.

T 1122/09 – The Deadly Four

The Boards’ requirements concerning the admissibility of auxiliary requests appear to be more and more restrictive. If you file auxiliary requests (1) that are not clearly allowable (2) belatedly and (3) in an unclear order, (4) without stating how those requests overcome the objections made so far, you have optimized your chances of having them rejected as being inadmissible.

In the present case, the patent proprietor filed an appeal against the decision of the Opposition Division (OD) to revoke the opposed patent.

The Board finds the claim as granted not to comply with A 123(2) and then deals with the admissibility of the auxiliary requests:

*** Translated from the German ***

[3] In its statement of grounds of appeal the [patent proprietor] only requested that the impugned decision be set aside and explained that it was of the opinion that the requirements of A 123(2) had been complied with. It is only in its written submissions of February 28, 2011, i.e. after the summons to oral proceedings (OPs) sent on January 17, 2011, and about one month before the OPs that the [patent proprietor] filed 23 auxiliary requests. In its letter it did not explain why those requests were filed at so late a moment in time, nor did it set out how the amendments should overcome the objections raised.

This behaviour on behalf of the [patent proprietor] is out of line with the Rules of proceedings of the Boards of appeal of the EPO (RPBA) […] and the corresponding case law (see “Case Law of the Boards of appeal of the EPO”, 6th edition (2010), VII.E.16), in several respects.

Pursuant to Article 12(2) RPBA the statement of grounds of appeal shall contain a party’s complete case. According to the established case law, this comprises not only all the arguments, facts and evidence but also all requests (see, e.g. T 764/03 [6.7]). Besides the very general request to set aside the first instance decision, in a letter of February 28, 2011, containing a request to maintain the patent as granted, the [patent proprietor] has not filed any explicit request together with the statement of grounds of appeal.

NB: The last sentence of the statement of grounds of appeal read as follows (my translation from the German):

“Moreover the written submissions filed during the opposition proceedings so far are maintained (gelten) in respect of the further arguments of the opponents, which were not discussed in the impugned decision.”

Pursuant to Article 13(1) RPBA any amendment to a party’s case after it has filed its grounds of appeal or reply may be admitted and considered at the Board’s discretion. The discretion shall be exercised in view of the complexity of the submission, the state of the proceedings and procedural economy. Pursuant to Article 13(3) RPBA, amendments sought to be made after OPs have been arranged shall not be admitted if they raise issues which require adjournment of the OPs.

When the patent proprietor intends to file amended claims during the appeal proceedings, this should be done at the earliest possible moment in time. A request that has not been filed in time will only be taken into account in exceptional circumstances, provided that the late filing is justified and the reason for the amendments is explained (see, e.g. T 95/83 [8]). None of these two criteria has been satisfied in the present case. The [patent proprietor] has not explained why the auxiliary requests were filed so late, nor did it state how the objections that had been raised were overcome by the proposed amendments. The Board does not see any reasons for this either. As the A 123(2) objection mentioned in the summons had already been part of the impugned decision, requests intended to overcome this objections could and should have been filed together with the statement of grounds of appeal.

Moreover, it is not obvious to the Board in which order the auxiliary requests 1 to 11, A and 1’ to 11’ were to be treated. In its written submission of February 28, 2011, the [patent proprietor] links these requests in an inadmissible way to certain requirements, which, moreover, are not clear.

NB: The patent proprietor’s fax of February 28, 2011, referred to a main request (claim 1 as granted), auxiliary requests 1 to 11 (“already on file before the OD and which were referred to in the statement of grounds of appeal”), an auxiliary request A, “to be discussed in case the main request is not granted”) and auxiliary requests 1’ to 11’’ (“which contain the limiting feature of the preamble of auxiliary request A […] but which, apart from that, correspond to auxiliary requests 1 to 11).

Finally, requests which, as the present requests, have been filed only shortly before OPs, are not to be taken into account if they are not clearly allowable (see, e.g. T 95/83). This is a decisive shortcoming of the present claims because all 23 auxiliary requests, very much like the main request, contain the combination of the features “projecting engaging means” and “sleeve”, which as shown above under point [2], violate the requirements of A 123(2). The fact that the “projecting engaging means”, according to auxiliary request A (and auxiliary requests 1’ to 11’), has the shape of a bulge or a needle pinch (Nadelquetschung) cannot alter this fact. For this reason alone, all 23 auxiliary requests are not clearly allowable.

Based on the reasons given above, the Board decides not to admit the 23 late filed auxiliary requests.

To read the whole decision (in German), click here.

The file wrapper can be found here.

T 1546/08 – Unexplored?

Both the patent proprietor and the opponent filed appeals against the decision of the Opposition Division (OD) to maintain the patent in amended form.

Claim 1 of the main request before the Board read:

“1. An intravascular stent (300) having an outer surface (302) and an inner surface (301), the improvement comprising:

at least one groove (400) disposed in the inner surface (301) of the stent (300), wherein the at least one groove (400) has a width, a length having a dimension greater than the width, and a depth less than the distance between the inner surface and the outer surface of the stent, the at least one groove (400) promoting migration of endothelial cells onto the inner surface (301) of the stent (300) when the stent (300) is implanted.”

Having found the requests on file to comply with the requirements of A 123(2), the Board considers the sufficiency of disclosure (paragraph [4] of the reasons) :

It has been contested that the disclosure is entirely silent about how the at least one groove has to be configured in order to promote migration of endothelial cells onto the inner surface of the stent when the stent is implanted, a feature which is present in both independent claims according to all requests. This feature relates to the technical problem of increasing the rate and/or speed of migration of these cells onto the inner surface […].

For the assessment of the requirements of A 83 it is not necessary for the Board to determine whether a desired effect, i.e. in the present case the promotion of migration of endothelial cells, has actually been obtained. It is also not the function of the Board to verify if an invention works properly. The disclosure is not required to comprise an explanation of how the desired effect is actually obtained, i.e. an indication of the underlying mechanisms. An invention is in principle sufficiently disclosed if at least one way is clearly indicated enabling the person skilled in the art to carry out the invention, and if the disclosure comprises the necessary technical information that permits the intended result to be achieved at least in some realistic cases (T 487/91 [5]). It should at least be plausible from the disclosure that its teaching does indeed solve the problem it purports to solve (T 1329/04 [12]).

In the Board’s view, this is the case in the situation under consideration here. As convincingly explained by one of the inventors, Mr. J. C. Palmaz, it is perfectly plausible that the edges of a groove influence the otherwise zig-zag type of migration of the endothelial cells on a flat surface such that they are guided by the edges of the groove to follow these edges. Their average velocity vector component along the groove thus increases and their migration rate hence becomes accelerated or “promoted” compared to that on a flat surface. All of the grooves depicted in the drawings clearly exhibit edges, and it is not necessary that the term “edge” as such and the resulting effect of guidance be explicitly mentioned or further described in the patent in order to enable the skilled person to carry out the invention as claimed.

The reference to construing the term “groove”, inter alia, as a “rounded indentation” in column 6, lines 7 to 10 of the specification is to be understood as relating to the U-shaped configuration of the groove shown in Figure 10 which also has edges, thus being in line with the explanation given above. The fact that in paragraphs [0009] and [0022] the expression “It is believed that ...” is used with respect to the property of the groove increasing the rate of migration represents the understanding of the authors, but does not imply a lack of sufficiency of disclosure.

In document D5 […] one of the inventors of the patent in suit (J. C. Palmaz) stated that introducing texture on a stent surface may have a beneficial effect on migration, but referred to this effect as a hypothesis which “has not yet been explored”. However, such a general and open statement does not mean that this effect does not exist or is impossible to achieve. It is per se not suited to raise serious doubts with regard to the sufficiency of the disclosure of the patent in suit.

Moreover, the symposium where the respective presentation was made took place from 15 to 17 October 1997, i.e. several weeks before the priority date of the patent in suit. At least within this period, it is quite possible that the unexplored hypothesis was actually verified.

Furthermore, a researcher familiar with the patenting system, like the above-mentioned co-inventor, is unlikely to take the risk of disclosing the details of a potentially patentable invention at a research conference before protecting it by filing a patent application.

In document D9 it is stated that grooves having a depth of 0.5 microns were found to have no effect on cell proliferation […]. However, this result relates to the proliferation of rat dermal fibroblasts, which are quite different from endothelial cells, which have the capability of forming monolayers. Moreover, these studies were performed on silicon substrates […], a material not normally used on stent surfaces. Accordingly, the teaching of this document does not cast any doubt on the sufficiency of the disclosure of the patent in suit. The introductory statement […] that the fundamental mechanisms of cell control by guidance in response to surface topography were still unknown is, like the sentence referred to in D5, very general and does not call into question the effect as such. The same applies to the statement […] where the influence of micro-geometrical surface patterns on cellular behaviour is referred to as a “hypothesis”.

If, in opposition appeal proceedings, the parties make contrary assertions regarding facts considered an obstacle to patentability, as in the present case, the patentee is given the benefit of the doubt, and the burden of proof lies primarily with the opponent (cf. Case Law of the Boards of Appeal of the EPO, 6th edition 2010, VI.H.5.1.1). The argument that routine in-vitro screening studies would not be sufficient for determining whether the grooves promote endothelialisation, which could only be established by means of in-vivo clinical trials representing an undue burden on the opponent, is not accepted by the Board.

The decision T 63/06 cited by the opponent in this respect is not applicable to the situation under consideration here since, as indicated above, the patentee has in fact presented plausible arguments on how the grooves promote endothelialisation, whereas the opponent has failed to present convincing counter-arguments or evidence raising serious doubts with respect to workability. Under these circumstances it is not justified to shift the burden of proof to the patentee. The evidence provided by the opponent (mainly based on D5 and D9) is not sufficient to call into question the sufficiency of the present disclosure. Such an objection is in principle justified only if there are serious doubts substantiated by verifiable facts (cf. Case Law of the Boards of Appeal of the EPO, 6th edition 2010, VI.H.5.1.1). Neither condition is fulfilled in the present case.

Accordingly, the invention as described in the present patent and defined in the claims according to the various requests is disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art as required by A 83.

Should you wish to read the whole decision, just click here. 

The file wrapper can be found here.