2.11.3.4A Principles for Examination

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.

In this topic:

Note: For a summary of the principles underlying clear enough and complete enough disclosure, support and usefulness, see 2.11A Annex B – Summary of the Clear Enough and Complete Enough Disclosure, Support and Useful (Utility) Provisions.

Overview

Subsection 40(2)(a) requires that a complete specification must disclose the invention in a manner that is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art.  

The Explanatory Memorandum states that in order to comply with sec 40(2)(a), the complete specification must provide sufficient information to enable the skilled person to perform the invention over the whole width of the claims, without undue burden or the need for further invention.  In this context, the ‘whole width of the claims’ should be understood as any embodiment falling within the scope of a claim.

This provision reflects a fundamental principle of international patent law that, in exchange for the exclusive rights given to the patentee, the patentee must share with the public the information necessary to make and use the invention.   

A specification that provides a single example of the invention may satisfy the requirements of a clear enough and complete enough disclosure, but only where the skilled person can extend the teaching of the specification to produce the invention across the full width of the claims, without undue burden, or the need for further invention.  However, where the claims are broad, it is more likely that the specification will need to give a number of examples, or describe alternative embodiments or variations, extending over the whole scope of the claims.  This ensures that the monopoly extends to that which could reasonably be said to be disclosed and no further.

As noted above, sec 40(2)(a) requires the complete specification, at the filing date, to disclose enough information to enable a person skilled in the art to perform the invention across the whole width of the claims (and not merely in relation to one embodiment amongst several), without undue burden or the need for further invention.  

In general, an invention should be disclosed in terms of its structure and function, unless the function of the various parts is immediately apparent.  However, in some technical fields (e.g. computers), a clear enough and complete enough disclosure of function may be more appropriate than an over-detailed disclosure of structure.  

For inventions involving biological material, the applicant may rely upon the Budapest Treaty in order to meet the clear enough and complete enough disclosure requirement.  

It is neither necessary, nor desirable, that the complete specification disclose every minor detail, where these can be derived from the common general knowledge in the art.  However, at the filing date, the complete specification must disclose any feature necessary for carrying out the invention as claimed, in enough detail to render it clear and readily apparent how to put the invention into practice.

While it is acceptable that the skilled person would need to use a reasonable amount of trial and error, there must be either adequate instructions in the specification, or basis in the common general knowledge in the art, to lead the skilled addressee towards success, through evaluation of initial failures.  

Test for Clear Enough and Complete Enough Disclosure

The test for a clear enough and complete enough disclosure was provided by Lord Hoffmann in Kirin-Amgen Inc v Hoechst Marion Roussel [2004] UKHL 46; [2005] RPC 9 at [103], as follows:

“Whether the specification is sufficient or not is highly sensitive to the nature of the invention.  The first step is to identify the invention and decide what it claims to enable the skilled person to do.  Then one can ask whether the specification enables them to do it.”

The application of this test is summarised below, and further information provided in the sections following.

First Identify the Invention and Decide What it Claims to Enable the Skilled Person to Do

For the purposes of sec 40(2)(a) ‘the invention’ is the claimed invention.  

“In order to decide whether the specification is sufficient, it is … first necessary to decide what the invention is.  That must be found by reading and construing the claims, in which the inventor identifies what he claims to be his invention.” (Lord Hoffmann in H. Lundbeck A/S v Generics (UK) Ltd [2008] EWCA Civ 311; [2008] RPC 19 at [29])

Where a claim is to a product per se, the product is the invention.  Where a claim is to a process, the invention is working the process. (H. Lundbeck [2008] at [27], [30])  

In general, for a product by process claim where the product is known, the invention is the process by which the product is made or otherwise obtained (Kirin-Amgen [2005] at [109]).  

The criteria for an enabling disclosure are the same regardless of the claim type.  Where a claim defines a product, process, or product by process, either wholly or in part by the result to be achieved, on its proper construction the claim may encompass a class of products, a class of processes, or a combination of these, respectively.  Once a ‘claim by result’ is construed to determine the scope of the invention, the same principles can then be applied to determine whether this type of claim satisfies the requirements of sec 40(2)(a).

Then Ask Whether the Specification Contains an Enabling Disclosure of the Claimed Invention

To constitute an enabling disclosure, the specification must provide sufficient information to enable the person skilled in the art to perform the invention to the full extent of the monopoly claimed.  

Where the claim is to a product or products per se, this means making or otherwise obtaining the product(s) over the whole scope of the claim (H. Lundbeck [2008] at [27], [30], [34]).  In the case of a process claim, performing the invention means working the process(es) over the whole scope of the claim (H. Lundbeck [2008] at [30], [34]).  In general, for a product by process claim, performing the invention will be working the process(es) to make or obtain the product over the whole scope of the claim.  In each case, this identifies what the specification must enable the person skilled in the art to do.

In determining whether the disclosure is clear enough and complete enough for the purposes of sec 40(2)(a), the specification must be assessed on its merits, based on a proper construction of the claims and the facts of the case.  

A claim to a product that can only have one embodiment (e.g. a single chemical compound), is enabled over its whole scope if the specification provides enough information for the skilled addressee, using the common general knowledge in the art, to make or obtain the product.  In this situation, the specification need only disclose one method of producing the product.  

However, where the claims encompass discrete (separate) methods or products, each must be sufficiently disclosed and enabled.  For example, a class of products or a class of processes will only be enabled if the disclosure teaches the person skilled in the art to make or work the invention in respect of all members of the class (H Lundbeck [2008] at [34]).

The level of disclosure required to enable a statement of claims will vary depending on the facts of the case.  The test for an enabling disclosure should not come down to the number of examples provided.  Rather, examiners should focus on whether the person skilled in the relevant art, based on the information provided in the specification, can perform the invention across the whole scope of the claims without undue burden, or the need for further invention.

Where the specification discloses a general principle that can be practically applied to make a class of products or to work processes, the level of disclosure required will be less than that required for claims that include a number of discrete products or methods that cannot be made or worked by applying a general principle (Biogen v Medeva [1997] RPC 1 at 48).   

Enablement via a Principle of General Application

Where the specification discloses a principle of general application, the claims may be drafted in correspondingly general terms.  Thus, examiners need only consider whether the specification discloses a principle of general application when a claim includes a feature drafted in broad general terms.    

A ‘principle of general application’ is a general principle that can be practically applied to make a class of products or to work a process, including where the claims define the product or process either wholly or in part by the result to be achieved.  Note that for claims to a product with only one embodiment, statements of general principle are for the most part irrelevant.  

A feature in the claims defined 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.  Claims containing such a feature will be sufficiently enabled if:

• the specification discloses at least one form of, or one application of, the general principle to perform the claimed invention; 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 (T484/92).  

Where this is the case, the specification need not exemplify every possible application of the principle.  

For further information, the applicable case law and examples, see 2.11.3.4.2A Section 40 Enabling Disclosures and in particular ‘Principles of General Application’ and 2.11A Annex A – Examples: Subsections 40(2)(a) and 40(3).

Enablement of Discrete Methods or Products

Where the claims include a number of separate or discrete methods or products, the specification must provide sufficient information to enable the person skilled in the art to make or obtain every product, and/or to carry out every method falling within the scope of the claims.  

The level of detail and number of examples required will vary depending on the area of technology and the particular invention.  Where the claims encompass a broad field, an enabling disclosure may involve one or more generic method(s) of production, 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 undue burden or the need for further invention.

For further information, the applicable case law and examples, see 2.11.3.4.2A Section 40 Enabling Disclosures and in particular ‘Discrete Methods or Products Must be Individually Enabled’ and 2.11A Annex A – Examples: Subsections 40(2)(a) and 40(3).

Undue Burden or the Need for Further Invention

In considering whether performing the invention would constitute an undue burden, regard should be had to the nature of the invention, and the abilities of the person skilled in the art in which the invention has been made.  The question can then be asked whether the specification requires the skilled addressee to carry out tests or developments that go beyond the routine.

Where it is prima facie apparent that the skilled addressee, seeking to perform the claimed invention following the directions in the complete specification, would take considerably longer than would be typically expected in the art given the nature of the invention, and/or that inventive ingenuity would be required, this would constitute an undue burden.

For further information, the applicable case law and examples, see 2.11.3.4.3A Undue Burden and 2.11A Annex A – Examples: Subsections 40(2)(a) and 40(3).

Objections Under Sec 40(2)(a)

Unless examiners are reasonably satisfied, on the balance of probabilities, that the complete specification complies with sec 40(2)(a), the objection should be raised.  The objection must include logically sound reasons supporting the assertion that the complete specification does not disclose the claimed invention in a manner which is clear enough and complete enough for the person skilled in the art to perform the invention over the whole width of the claims.  The reasoning may, for example, be based on the examiner’s personal knowledge, statements made in the specification, the prior art or other matter on file (e.g. in third party re-examination requests or matter filed under sec 27).

An ambiguity in the claims, where it causes doubt as to the scope of the invention, may lead to an objection under sec 40(2)(a) that the invention has not been enabled over the whole width of the claims.  However, in extreme cases where the scope of the claims cannot be determined, it may be preferable to object to a lack of clarity in the claims, and reserve examination under sec 40(2)(a) and/or sec 40(3) until the clarity objection has been resolved.

Note: Although a deficiency may lie predominantly in the clarity or the completeness of the disclosure, objections under sec 40(2)(a) should use the phrase ‘clear enough and complete enough disclosure’.

Considering a Response to an Objection Under Sec 40(2)(a)

A mere assertion will not be enough to overcome a well-reasoned objection under sec 40(2)(a).  However, where the applicant provides evidence or credible and plausible submissions that adequately address the examiner’s concerns by establishing that, on the balance of probabilities, the disclosure is clear enough and complete enough, the objection should be withdrawn.

Objections under sec 40(2)(a) cannot be overcome by the addition of new matter extending beyond that disclosed by the specification as filed (together with other prescribed documents), since this is prohibited under sec 102(1) (see 2.23.8A Allowability Under Section 102(1)).  However, an objection to an excessive breadth of the claims may be remedied by restricting the scope of the claims.  If a proposed amendment restricting the claims is not otherwise allowable under sec 102, a standard patent application cannot be accepted and an innovation patent cannot be certified.

Where an issue is not resolved despite subsequent adverse reports, the supervising examiner should consult Patent Oppositions on the further progress of the case, including whether to set the matter for hearing with the intent to refuse the application.