Sufficiency of Disclosure and Drafting Rules

Article 83 EPC provides:

The European patent application must disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.

Sufficiency of Disclosure

Assessment Date

Sufficiency of disclosure, for assessing the validity of a patent or application, is evaluated as of the filing date of the application (Guidelines F-II 4.1).

To determine whether prior art anticipates an invention, the assessment of sufficiency of disclosure differs: it must be evaluated as of the publication date of that disclosure (or the filing date for an Article 54(3) EPC document) (T206/83, T26/85 and Guidelines G-VI 4).

Assessment Criterion

Sufficiency of disclosure is assessed with reference to (Guidelines F-II 4.1):

• the basic general knowledge of the person skilled in the art;
• the invention described in the application;
• the cited documents.

If products are claimed, only their manufacture must be sufficiently disclosed (T866/00): it is not necessary to describe their use.

Tests for Verifying Sufficiency of Disclosure

To verify that the description is sufficient for carrying out the invention, the Boards of Appeal have proposed a 4-step test (T593/09, T2403/11):

1. Identification of the problem solved by the invention;
2. Is the feature alleged to be insufficiently disclosed (e.g., porosity threshold of a material) relevant to solving this problem?
3. Is there possible ambiguity regarding the measurement/estimation of this feature?
   • e.g., several measurement methods yield different results, or measurements vary depending on conditions (T2096/12);
   • a measurement using a specific machine is mentioned in the description, but this machine is no longer manufactured (T1293/13), and it is impossible to determine whether new machines yield the same result;
4. Is the ambiguity such that the invention is not sufficiently disclosed? (e.g., discrimination of materials satisfying the technical problem is not possible).

Once this test is completed, it becomes possible to determine whether the invention is insufficiently disclosed.

Measurement of Parameters

It should be noted that imprecisions regarding the measurement of a parameter or the existence of multiple measurement methods do not necessarily lead to insufficiency of disclosure (T608/07, T1768/15) but often result in clarity issues.

However, where the parameter is crucial for solving the underlying problem of the invention, the measurement method must yield consistent values so that the person skilled in the art knows, when reproducing the invention, whether what they produce solves the problem (T815/07, T1305/15): this then becomes an issue of sufficiency of disclosure.

Case of neural networks

In the case of an invention using a neural network, we may wonder whether it is useful/necessary to describe how the neural network was trained.

This is all the more relevant as training neural networks requires several megabytes (or even gigabytes) of data, and it is not really feasible to include this data in the text of the application.

According to case law (T161/18), merely indicating in general terms that the training data must cover a broad scope (e.g., patient age, gender, etc.) is not sufficient.

It is likely that the types of data and the parameters/hyperparameters used must be specified precisely. But to what extent remains a real question…

Case of drugs/pharmaceutical compositions

It may happen that an invention relates to a drug or a pharmaceutical composition without the application including clinical tests proving that the drug/pharmaceutical composition has the claimed efficacy/effect.

However, this is not sufficient for a lack of sufficient disclosure objection to be raised (T2015/20): An invention is sufficiently disclosed only if it does not run counter to a prevailing technical opinion and the patent provides at least one reproducible example.

This is therefore not a question of plausibility (which then pertains to inventive step).

Described embodiments

Claim broader than the described embodiments

Principle

According to certain decisions, the disclosure must be sufficient to enable the implementation of almost all the embodiments covered by the claim (T409/91).

Nevertheless, other decisions consider that the requirement of sufficient disclosure is met if at least one embodiment is described (T292/85 or T389/94).

It is therefore necessary to examine the facts: if the invention is highly innovative, it can often be easily generalized once the person skilled in the art has been guided toward one embodiment (Guidelines F-III 1).

Thus, the description of a single embodiment will more readily be accepted if the invention is innovative (Guidelines F-III 1).

A limited degree of trial and error may be acceptable, for example, in a field that is still unexplored or where numerous technical difficulties arise (T292/85, T409/91 and Guidelines F-III 1).

A broad claim may be allowable if it is possible to extend the given examples using standard experimentation or analytical methods (Guidelines F-IV 6.3).

« Forbidden area » of a claim or disguised clarity objection

It may happen that a feature is so unclear that the person skilled in the art is unable to determine whether they are working within the claimed scope (« forbidden area »).

Many opponents have often attempted to argue that this constituted an issue of insufficient disclosure (clarity not being a ground for opposition).

However, today, the boards of appeal are fairly unanimous: the definition of the claimed scope was a matter of EPC Article 84 rather than EPC Article 83 (T1811/13).

Care must be taken to ensure that an insufficiency objection arising from ambiguity is not merely a disguised clarity objection (T608/07, 2.5.2).

Embodiment or operating range…

… not working across the entire scope of the claim

Burden of proof

If it is alleged that, when following the details provided in the description, certain ranges or embodiments do not work, the party raising this issue must provide supporting evidence (i.e., serious reservations, substantiated by verifiable facts, T409/91, T1057/22 and T694/92).

However, this does not mean that, as soon as a range covered by the claim does not work, there is insufficient disclosure. Indeed, when it is clear to the person skilled in the art that such a range is not reasonable or does not work (does not achieve the technical effect), there is no issue (T1943/15, T2773/18).

However, and this is where the real difficulty lies, a limiting feature that appears only in the description cannot be considered implicit in the claims (T989/16).

Objection of insufficient disclosure

If a claim covers several embodiments and some do not work, the claim will be considered insufficiently disclosed even if the other embodiments work correctly (T1173/00, T239/13).

Alternative to this objection

An objection regarding lack of industrial applicability (A52(1) EPC) may also be raised (Guidelines F-III 3).

… no longer working

It may happen that an embodiment can no longer be implemented.

This occurs when the embodiment is so specific that a particular machine is required to implement it, and that machine no longer exists (e.g., energy of an impact measured using the Rheometrics, Inc. Drop-Weight Tester RTD-5000, T1714/15).

In this case, there is an issue of insufficient disclosure.

… not always working (related to chance)

It may happen that the successful execution of the invention depends on chance (Guidelines F-III 3).

Thus, the details provided in the description do not systematically allow the desired result to be obtained (Guidelines F-III 3):

• manufacture of electronic chips;
• microbiological process involving mutations;
• etc.

These inventions will only be considered sufficiently disclosed if (Guidelines F-III 3):

• satisfactory results can be obtained repeatedly, even if there are failures; and
• it is possible to determine whether the result is satisfactory using non-destructive testing methods.

… not always working (reliability below 100%)

It may happen that certain mechanical devices do not have absolute reliability (e.g., mechanical sorting apparatus).

The person skilled in the art must therefore strive to adopt a constructive rather than a destructive approach in order to arrive at a technically meaningful interpretation of the claim that takes into account the entire disclosure of the invention in the patent (T383/14).

Thus, even if a mechanical sorting machine occasionally makes sorting errors, the invention will be considered sufficiently disclosed.

… difficult to implement or imperfect

The difficulty in implementing an invention does not necessarily mean that the invention is insufficiently described (Guidelines F-III 5.3).

Thus, an embodiment that does not function perfectly (e.g., an electrical switch allowing a slight residual current to pass when open) and rendering certain applications of the invention inoperative only in some cases (e.g., an electrical circuit requiring absolutely no current when the switch is open) will be considered sufficiently described (Guidelines F-III 5.3).

… not solving the technical problem

If the invention does not achieve the alleged technical effect, it is only possible to reject the application on the grounds of insufficient description if that technical effect is claimed (G1/03, point 2.5.2 or T2001/12).

However, if the failure to achieve the technical effect is linked (T2001/12):

• to the absence of an essential feature, an objection of lack of clarity may be raised;
• to the technical impossibility of achieving the effect in view of prior art assertions, an objection of lack of inventive step may be raised.

We can summarize the decision G1/03, point 2.5.2 as follows:

… citing trademarks, proper names, trade names

Indeed, these terms merely constitute an indication of origin and may refer to a whole range of different products.

To be sufficiently described, the product must be sufficiently identified, without reference to any trademark, proper name, or trade name, to enable the implementation of the invention, unless these terms have a precise meaning for the person skilled in the art (e.g., « Bowden » cable, « Belleville » washer, « Panhard » rod, « Caterpillar » track) (Guidelines F-III 7).

If a branded product is mentioned but the composition and manufacturing method of said product is secret, it is highly likely that the requirement of sufficient description is not met (T797/14).

Number of embodiments described

The description must include, at a minimum, the description of one embodiment covered by the claims (Guidelines F-III 1), this embodiment functioning (see above, Guidelines F-III 5.1).

While one embodiment may suffice, it may be advisable to provide several, particularly if the claim wording is broad and the common general knowledge of the person skilled in the art is insufficient to extrapolate the implementation of embodiments not described but covered (T727/95) by the claims.

Non-« classic » method

When the applicant chooses to use non-standard methods (e.g., measurement methods), it is advisable to detail them particularly to ensure that these methods are sufficiently described (T602/10).

Incorporation by reference

A filing will not be insufficiently described if an essential element of the description is mentioned by reference only without being reproduced in full.

The language of the cited document is irrelevant (T920/92).

The reference will be valid if (Guidelines H-V 2.5 together with Guidelines H-IV 2.3.1):

• on the filing date, a copy of that document was available to the EPO (which is the case if it is another European patent application, T737/90);
• on the publication date, that document was publicly accessible (T426/96).

Burden of proof

The burden of proof initially lies with the opponent/Examining Division to demonstrate, on the balance of probabilities, that a person skilled in the art would be unable to reproduce the invention, and if the opponent/Examining Division has discharged its burden of proof, it then shifts to the proprietor who seeks to rebut the facts definitively established by counter-arguments (Guidelines F-III 1, Guidelines F-III 4, T518/17).

Sanction

In the event of insufficient description, the claims should be limited to exclude embodiments that are insufficiently described (Guidelines F-III 2).

Furthermore, it is not possible, after the filing, to add the missing description to the application in order to « render » the invention sufficiently described: indeed, such an amendment would contravene Article 123(2) EPC.

Sufficiency of the claims

As you are all aware, claims form part of the description in Europe. Consequently, they contribute to the sufficiency of the description (Article 83 EPC).

In fact, an issue of insufficient description may be raised if the claims do not present the invention in a sufficiently complete manner for the invention to be carried out (i.e., if, for example, essential features are missing Rule 43(1) EPC).

Indeed, the person skilled in the art must find in the claims indications of the essential features for implementing the invention in its full scope. If they cannot, there is an issue of sufficiency (T623/16).

Drafting rules for the description

Principle

Rule 42 EPC precisely defines the requirements that the description must satisfy.

This rule aims to (Guidelines F-II 4.1)

• ensure that the patent application contains sufficient technical information for a person skilled in the art to carry out the invention as claimed,
• enable the reader of the disclosure to understand the contribution made to the prior art by the invention as claimed.

Prior art

If the search report reveals relevant documents, a reference to these documents may be required (R42(1) b) EPC) along with a brief summary.

This a posteriori introduction does not contravene A123(2) EPC (T11/82).

If the Examiner requires that a reference be introduced, this requirement must be complied with, failing which the application may be refused (A97(2) EPC) or the patent revoked (A101(3) b) EPC).

If prior art is A54(3) EPC, it is useful to mention it in the application (Guidelines F-II 4.3).

Technical problem and solutions

R42(1) c) EPC requires that the technical problem be derivable from the application.

The statement of the problem must not include disparaging statements (Guidelines F-II 4.5).

It is possible to draft this solution by reference to the claims: « This problem is solved by the device of claim 1 » (this is permissible in France).

Description of at least one embodiment

Reference should be made to the chapter on sufficiency of disclosure regarding this description (R42(1) e) EPC).

A simple copy-paste of a computer program does not suffice to meet this requirement (Guidelines F-II 4.12), even if it is permissible to illustrate the invention.

Industrial application

In most cases, this industrial application (R42(1) f) EPC) can be directly derived from the application, and it is not necessary to state it explicitly.

If it is not obvious (e.g., a test method), it must be explicitly stated (Guidelines F-II 4.9).

Its mention is mandatory for an invention relating to a gene sequence (R29(3) EPC).

Incorporation by reference

Principle

It is possible to incorporate into a claim a feature present in a document cited in the application, provided it is evident that this document forms part of the invention for which protection is sought (T6/84).

The language of the citation is irrelevant (T920/92).

A123(2) EPC

Therefore, if this incorporation by reference is essential for the invention, the applicant must explicitly integrate these features into the description (Guidelines F-III 8).

For this integration not to contravene A123(2) EPC, the following must apply (Guidelines H-V 2.5, T689/90):

• protection is or could be sought for these features;
• such features contribute to achieving the technical objective pursued by the invention and thus form part of the solution to the technical problem underlying the claimed invention in the application;
• such features are clearly implicitly comprised in the description of the invention that the application must contain at the time of filing (A78(1) b) EPC), and therefore form part of the content of the application as filed (A123(2) EPC);
• said features are defined precisely and can be identified among all the technical information contained in the reference document.

The mere citation of a document is not, in principle, sufficient (T276/99). However, the statement « the polymer of document D1 is advantageous » is sufficiently precise.

Public availability of the reference

The reference will be valid if (Guidelines H-V 2.5 together with Guidelines H-IV 2.3.1):

• at the filing date, a copy of this document was available to the EPO (which is the case if it is another European patent application, T737/90);
• at the publication date, this document was publicly available (T426/96).

Prohibited elements

The description must not contain (R48(1) EPC):

• elements contrary to public policy;
• disparaging statements;
• irrelevant or superfluous elements.

The filing section verifies these conditions (A90(3) EPC) and omits these elements in the publication of the application (Guidelines A-III 8.1).

If such elements are only found at the examination stage, the examining division will request their removal (Guidelines F-II 7.5).

Deposit of biological material

Introduction

This topic is addressed here because, although it is not strictly part of the description, the deposit of biological material is a key element for sufficiency of disclosure.

Definition of biological material

Biological material is defined as material that (R26(3) EPC):

• contains genetic information;
• and, in a biological system:
  • is self-reproducible or
  • reproducible.

Conditions to be met

Principle

To meet the requirement of sufficient disclosure, the following must be satisfied:

• a sample of the biological material has been deposited with a recognized depositary authority (R31(1) a) EPC):
  • cf. Budapest Treaty of April 28, 1977;
  • no later than the filing date of the application (to allow the Examiner access to it, Guidelines F-III 6.2);
  • the recognized depositary authorities (approximately 40) are listed (« 4.2 International depositary authorities under Article 7 of the Budapest Treaty« , JO 2012, 324, II.1.4 and I.4.2):
• the application contains the relevant information available to the applicant concerning the characteristics of the biological material (R31(1) b) EPC). Generally, this relevant information includes (Guidelines F-III 6.3):
  • the classification of the biological material (e.g., for bacteria, the relevant literature for classification will be R.E. Buchanan, N.E. Gibbons: Bergey’s Manual of Determinative Bacteriology);
  • significant differences from known biological materials;
  • morphological and biochemical characteristics, to the extent that the applicant has such information;
    • useful information for the recognition and reproduction or multiplication of the biological material, such as suitable media (ingredient composition);
  • the proposed taxonomic description, to the extent that the applicant has such information;
  • if the deposited biological material cannot reproduce itself but must be reproduced in a biological system (e.g., viruses or free RNA), the aforementioned information for that biological system (possibly combined with a deposit of that biological system);
• the following must be provided for the deposited biological material:
  • the indication of the depositary authority (R31(1) c) EPC);
  • the indication of the accession number (R31(1) c) EPC).
• if the biological material was deposited by a person other than the applicant, the following must be provided (R31(1) d) EPC):
  • the name and address of the depositor;
  • a document proving that the depositor
    • has authorized the applicant to refer in the application to the deposited biological material, and
    • has given unreserved and irrevocable consent to make the deposited material available to the public.

However, the mere deposit of a biological material cannot constitute a patent application in itself (T418/89).

Case of reference to an earlier application

When an application is filed by reference to an earlier application, the following conditions are deemed to have been met at the filing date to the extent that they were met at the filing date of the earlier application (Guidelines A-IV 4.1.2):

• relevant information available to the applicant concerning the characteristics of the biological material (R31(1) b) EPC);
• indication of the depositary authority for the deposited biological material (R31(1) c) EPC);
• indication of the accession number of the deposited biological material (R31(1) c) EPC).

Procedure

Verification

The filing section verifies, during the examination as to certain irregularities (A90(3) EPC), whether the application meets the requirements of R31(1) c) EPC and R31(1) d) EPC (Guidelines A-III 1.2 iv).

If the filing section finds that the information is missing, it informs the applicant (Guidelines A-IV 4.2).

Time limit for correction

The time limit for correcting this irregularity is (R31(2) EPC, minimum of the following time limits):

• 16 months from the priority date (or at least before the end of the technical preparations for publication);
• before any request for early publication under A93(1) b) EPC;
• 1 month after notification to the applicant that a third party may inspect the file because an action has been brought against them (A128(2) EPC).

A122 EPC is applicable.

This time limit does not therefore run from the notification indicating the irregularity.

If the information under R31(1) c) EPC and R31(1) d) EPC is provided after this time, the application will be insufficiently described (Guidelines F-III 6.3) even if it is provided later:

• via a correction under R56 EPC,
• via the submission of an earlier application to which reference is made under R40 EPC.

Refusal of the application

If a provision of R31(1) EPC is not complied with, the description is insufficient and the application is refused under A97(2) EPC (Guidelines F-III 6.3).

In this case, the loss of rights occurs as of the filing date (even if a filing date is accorded).

Thus, even if the application is refused, the priority of this first application may be validly claimed by a second application if and only if for this first application, a sample was deposited no later than the filing date of the first application (i.e., R31(1) a) EPC was complied with) by application of A88(4) EPC (T193/95).

Access to biological material

Principle

Normally, from the date of publication of the patent application, the biological material is accessible to any person who requests it (or earlier by a third party if an action is brought against that third party under A128(2) EPC) (R33(1) EPC):

• if the applicant has so requested before the completion of the technical preparations for publication (R32(1) EPC):
  • a sample is provided to an expert if the request for access is made:
    • before the publication of the mention of grant (R32(1) a) EPC);
    • before the expiry of a period of 20 years from the filing date if the application is refused / withdrawn / deemed withdrawn (R32(1) b) EPC);
  • the experts may be:
    • any natural person designated by the person wishing to access the biological material, if they prove at the time of the access request that the applicant agrees (R32(2) a) EPC);
    • a person approved by the President of the EPO (fewer than 20 experts who have not changed since 1992, list in « 1.5 Experts in microbiology approved by the President of the EPO in accordance with Rule 32, paragraph 2, letter b EPC« , OJ 2012, 324 which refers to « List of experts approved for the purposes of R28 EPC« , OJ 1992, 470) (R32(2) b) EPC);
• otherwise,
  • a sample is then provided directly to that person.

Restriction on use

However, the person who has access to this material must undertake to (R33(2) EPC) (until the patent ceases to have effect in all States or until the application is refused / withdrawn / deemed withdrawn):

• not to make it available to any third party (even derivatively):
  • unless the applicant authorizes it,
  • unless the material derived therefrom is made available for the purpose of filing biological material (R33(3) EPC) for a patent procedure;
• to use it for experimental purposes only:
  • unless the applicant authorizes it;
  • unless that person holds a compulsory license.