2.11.3.4.2A Section 40 Enabling Disclosures

Date Published

Note: The information in this part only applies to:

  • standard patent applications with an examination request filed on or after 15 April 2013.
  • innovation patents with an examination request filed on or after 15 April 2013.
  • innovation patents where the Commissioner had not decided before 15 April 2013 to examine the patent.  

For all other standard patent applications/innovation patents, see 2.11.3.4 Enabling Disclosures.


Overview

Both sec 40(2)(a) and sec 40(3) require the specification to provide an enabling disclosure of the claimed invention.  Under sec 40(2)(a), the clear enough and complete enough (enabling) disclosure must be found in the complete specification.  In contrast, for sec 40(3), the enabling disclosure supporting the claims must be found in the body of the specification (the description and any drawings, graphics and photographs and sequence listing).  

Note: In this part, references to ‘the specification’ should be construed as the complete specification when considering sec 40(2)(a) or the body of the specification when considering sec 40(3).

The enabling disclosure required for sec 40(2)(a) and sec 40(3) overlaps with, but is not exactly the same as, the enabling disclosure required in a novelty citation.  For novelty purposes, the person skilled in the art has no knowledge of the claimed invention, and consequently the enabling disclosure must provide ‘clear and unmistakable directions’ to do what is claimed.  In contrast, for sec 40, the person skilled in the art has read the specification, knows what is claimed and consequently, what is to be achieved.  A sec 40 enabling disclosure is one that provides the person skilled in the art with sufficient information to achieve what is claimed, without undue burden or the need for further invention.

In Biogen v Medeva [1997] RPC 1 at 48 Lord Hoffmann explained the concept of an enabling disclosure:

“… the specification must enable the invention to be performed to the full extent of the monopoly claimed.  If the [specification] discloses a principle capable of general application, the claims may be in correspondingly general terms.  The [applicant] need not show that he has proved its application in every individual instance.  On the other hand, if the claims include a number of discrete methods or products, the [applicant] must enable the invention to be performed in respect of each of them.”

For the purposes of sec 40(2)(a) and sec 40(3) ‘the invention’ that must be enabled is the invention defined by the claims (see 2.11.3.4A Principles for Examination and in particular ‘First Identify the Invention and Decide What it Claims to Enable the Skilled Person to Do’).  

‘Principles of general application’ and ‘discrete methods or products’ and the need for the specification to disclose all features necessary for carrying out the invention are discussed more fully below.


Principles of General Application

Note: Statements of general principle relate mainly to inventions with many embodiments and are for the most part irrelevant to an invention which consists of a single embodiment, such as a single chemical compound (Generics (UK) Limited and others v H Lundbeck A/S [2009] UKHL 12; [2009] RPC 13 at [25]).

Where the specification discloses a principle of general application, the claims may be drafted in correspondingly general terms (Biogen v Medeva [1997] RPC 1 at 48).  A ‘principle of general application’ is a general principle that can be practically applied in making a class of products, or in working a process, including where the claims define the products or process(es) in terms of the result to be achieved.  

Examiners need only consider whether the specification discloses a principle of general application when a feature of a claim is broadly drafted in general terms.  

A feature in the claims stated in general terms will represent a ‘principle of general application’, where it is reasonable to expect (reasonable to predict) that the claimed invention will work with anything that falls within the general term.  Such a feature defined in general terms may be a major part of the claim, or it may be a humble descriptive word.  In either case, a feature in the claims expressed in general terms will be sufficiently enabled if the disclosure enables at least one form of, or one application of, a general principle in respect of the feature, and the person skilled in the art would reasonably expect the invention to work with anything that falls within the general term. (Kirin-Amgen Inc. v Hoechst Marion Roussel Ltd [2005] RPC 9 at [112])  

In a simple example, a reference in a claim to ‘connecting means’ will be enabled if the claimed invention can be reasonably expected to work with any means of connection; the applicant does not need to have experimented with all of them.  Similarly, in the chemical arts the scope of the general terms ‘leaving group’ or ‘protecting group’ is well understood and an example of one member of the group would normally provide an enabling disclosure for a claim referring to all members.  

Where the claims are more broadly drafted they may be considered enabled if, prima facie:

i. the disclosure teaches a principle that the person skilled in the art would need to follow in order to achieve each and every embodiment falling within a claim; and

ii. the specification discloses at least one application of the principle and provides sufficient information for the person skilled in the art to perform alternative applications of the principle in a way that, while not explicitly disclosed, would nevertheless be obvious to the person skilled in the art (T 484/92).  


Discrete Methods or Products Must be Individually Enabled

The disclosure of one method of making a single product with only one embodiment provides an enabling disclosure across the full scope of a claim to the single product per se.  An applicant is not required to enable the person skilled in the art to make the same product by all possible methods. (Generics (UK) Limited and others v H Lundbeck A/S [2009] UKHL 12; [2009] RPC 13 at [80])  

Where the claims include a number of discrete processes or products, the question to be asked is whether the enablement of one provides enablement of the others.  Where there are different embodiments, each must be sufficiently disclosed and enabled. (Chiron Corp. and Ors v Murex Diagnostics Ltd and Ors [1996] RPC 535 at 612-613)  In this situation, the disclosure of a single embodiment will not always satisfy the requirement for an enabling disclosure (Biogen Inc v Medeva PLC [1997] RPC 1 at 22).  

Where the claims encompass a broad field (for example, a broad class of products), an enabling disclosure may involve a number of generic method(s) of production (each enabling different subgroups within the broad field), or a number of examples or alternative embodiments or variations, sufficient to enable the person skilled in the art to perform the invention over the whole scope of the claims, without an unreasonable amount of trial and error.  

Claiming by Result

The criteria for an enabling disclosure are the same regardless of the claim type and are not stricter where a claim is limited by the result to be achieved.  A claim defining an invention, either wholly or in part by the result to be achieved, should be construed to determine its scope.  Properly construed, the claim may encompass, for example, a class of products having particular properties, a class of processes that achieve a particular result, or a combination of these in a product by process claim.

Where a claim defines the invention in terms of desirable results, if on a proper construction of the claim, it encompasses a class of products or processes, the specification will need to provide enough instruction for the skilled person to make each product and/or work all the processes that are encompassed by the claim, without undue burden or the need for further invention (see 2.11.3.4.3A Undue Burden and 2.11.7.6A Claiming by Result).  

Individual Features Defined by Function

Where a feature of a claim is defined in functional terms, the person skilled in the art must understand it and be able to implement it (T 568/97).  

A claim may broadly define a feature in terms of its function, where only one example of the feature has been explicitly disclosed, provided the skilled addressee would appreciate that other means could be used for the same function.  Where a functional feature in a claim encompasses a vast range of possible alternatives, the claim will not be enabled unless the person skilled in the art would reasonably expect the claimed invention to work with anything that falls within the scope of the functional definition (see ‘Principles of General Application’ above).

Where the claim defines a class of functionally-defined products and the specification teaches a process for making a vast number of products that may or may not have the function as claimed, the disclosure will not be enabling for the claimed invention, unless it teaches the person skilled in the art how to ascertain which of the products actually has the required properties (American Home Products Corp v Novartis Pharmaceuticals UK Ltd [2001] RPC 8 at [39]-[43]).  Where a screening method is provided, a further consideration is whether the time required to screen every product would impose an undue burden on the person skilled in the art (see 2.11.3.4.3A Undue Burden).

Parametric Claims

Parametric claims are in effect, claims by result and should be examined accordingly.  If the claims define the invention, either wholly or partly in terms of parameters, the specification as filed must disclose a means to achieve and/or determine the parameter values, unless a person skilled in the art would know what method to use or all methods would yield the same result.

For example, a claimed product comprises two components, each selected from separate vast lists.  To perform the invention, the person skilled in the art is required to select a pair of components to achieve particular desirable characteristics in the final product.  In this situation, the specification would lack an enabling disclosure where:

i.the specification contains little or no guidance on how to select a pair of components which would achieve the desired characteristics in the resulting product; and/or

ii. the specification provides no information on how the desirable characteristics could be measured or otherwise determined in a product containing any pair of components.

In such cases, it is relevant to consider whether performing the invention over the whole scope of the claims would impose an undue burden (see 2.11.3.4.3A Undue Burden and 2.11.2.3.12 Parametric Claims).

Reach-Through Claims

‘Reach-through’ claims define compounds in terms of specific properties identified in a screening assay.  This style of claim is more prevalent in the chemical and biochemical areas, and in many cases such claims will not be enabled.  

For further information, see 2.11.7.7A Reach-Through Claims and 2.11 Annex A –Examples: Subsections 40(2)(a) and 40(3).

Synergism

Examiners should consider whether a specification provides an enabling disclosure where it claims compositions comprising a ‘synergistic’ combination of two or more compounds.  

Synergism between compounds is unpredictable in nature and not all combinations of any two or more compounds will necessarily exhibit this property.  Consequently, where the specification claims a synergistic combination and the specification contains little or no guidance on, for example, appropriate concentrations or ratios of the compounds that will provide the synergistic result, it may impose an undue burden on the person skilled in the art to test all possible combinations to determine those that fall within the scope of the claims.


Specification Must Disclose the Features Necessary to Successfully Perform the Invention Where These do not Form Part of the Common General Knowledge in the Art

If a feature in a claim has a limiting effect, but the specification gives no teaching of how the feature is to be achieved, or how the presence or absence of the feature can be determined, and this information does not form part of the common general knowledge in the art, the specification does not provide an enabling disclosure of the invention claimed (Minnesota Mining & Manufacturing Co’s (Suspension Aerosol Formulation) Patent [1999] RPC 135).

Choice of Components and Starting Materials

Where a particular component from a broad class or group is necessary to perform the invention as claimed, the specification must identify that component.  If the specification merely refers to the broad class or group, the disclosure is not enabling.

The starting materials in a process, or the ingredients in a composition, must be known in the art.  If they are not part of the common general knowledge in the art, a method of preparing those starting materials or ingredients from known materials should be disclosed in the specification.  A statement in the specification that the starting material/ingredient is obtainable, or otherwise known, should generally be accepted.  Reference to a material/ingredient by a trade name or by another commercial identification, whilst possibly unsatisfactory in other respects, may be considered as a prima facie indication that the material/ingredient is known (see also 2.11.3.8A Trade Marks in Specifications).


Repeatability (Successful Performance of the Invention Depends on Chance)

Successful performance of the invention is dependent on chance where the person skilled in the art, following the instructions for carrying out the invention, finds either that the alleged results are unrepeatable or that success is achieved in a totally unreliable way.  In this situation, there is a fundamental insufficiency in the description of the invention, such that the complete specification cannot be considered to provide a clear enough and complete enough disclosure.

However, an invention dependent purely on chance should be distinguished from one where repeated success is assured, even though accompanied by a proportion of failures (as can arise, for example, in the manufacture of small magnetic cores or electronic components).  In the latter case, provided the ‘successes’ can be readily separated from the failures by a non-destructive testing procedure, the disclosure of the invention will be sufficiently enabling.