5.6.7.8 Annex A - Examples: Subsections 40(2)(a) and 40(3)

Date Published

Note: During examination, each application should be considered on its own merits, based on a proper construction of the specification and claims and the facts of the case.  These examples are provided for guidance only and are not intended to establish rules to be followed outside the principles for examination outlined in 5.6.7.2 Clear Enough and Complete Enough Disclosure and 5.6.7.3 Support for the Claims.

On this page

  • Section 40 Enabling Disclosure (Including Undue Burden)
  • Chemistry
  • Synergism
  • Markush Claims
  • Biotechnology
  • Broad Claims
  • Reach-Through Claims
  • Antibody Claims
  • Methods of Treatment
  • Pharmaceutical
  • Mechanical
  • Computer-Related Inventions
  • Support (Broader Than is Justified by the Contribution to the Art)
  • Chemistry
  • Biotechnology
  • Support (Inconsistency)
  • Claims Supported Despite Apparent Inconsistencies

Section 40 Enabling Disclosure (Including Undue Burden)

Under s40(2)(a), the clear enough and complete enough (enabling) disclosure must be found in the complete specification.  For s40(3), the enabling disclosure to support the claims must be found in the description, drawings, graphics, photographs and sequence listing.  Subject to this distinction, in general where the disclosure is not enabling, objections under both s40(2)(a) and s40(3) will apply.

Chemistry

  1. Where the applicant claimed a surgical suture made of a particular polymer, and the application did not indicate the need for adequately drying the polymer and freeing it from undesired monomer, the complete specification was found to provide an enabling disclosure, since these were steps which ‘the instructed reader desirous of achieving success could be expected, if necessary, to take’ (American Cyanamid v Ethicon [1979] RPC 265).
  2. The claims defined an amphiphilic segment polyurethane in a block co-polymer in broad functional terms, i.e. the desired end effect.  The application disclosed one mechanism of achieving this result.  In this case, there was no suggestion that the desired end effect was a known goal.  The claims were enabled because the specification disclosed a principle of general application, and alternative ways of applying the principle to perform the invention over the whole scope of the claims would have been apparent to the person skilled in the art based on the common general knowledge in the art (EPO T 484/92).

Synergism

3. Claims often define 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 claims define 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 would impose an undue burden if the person skilled in the art was required to test all possible combinations to determine those falling within the scope of the claims.

Markush Claims

In order that claims defining a class of compounds in terms of a Markush structure are supported over their whole scope, the body of the specification must provide sufficient information to enable the skilled addressee to make every compound falling within the scope of the claims.  

Where the activity of the class of compounds is a feature of the claim, the class of compounds must be such that the person skilled in the art would have a reasonable expectation that all of the class members will behave in the same way, in the context of the invention disclosed in the specification.  If this is not the case, the specification, or the common general knowledge in the art, must provide a means by which the compounds with the relevant activity can be identified without imposing an undue burden on the skilled addressee (see 5.6.7.2 Clear enough and complete enough disclosure s40(2)(a)).  

4. The specification teaches a Markush structure having a particular pharmacophore to which activity is attributed, and there is a reasonable prediction of activity across the whole scope of the claims.  The specification only exemplifies a narrow subset of compounds and provides a generic synthetic scheme for only a subset of the claimed class.  

The disclosure will not be enabling if the specification provides insufficient guidance for the person skilled in the art to make each and every compound falling within the scope of the claims, and this information cannot be derived from the common general knowledge in the art.  This will be the case whether or not the activity is a feature of the claim.


5. The specification discloses a broad Markush formula and discloses schemes and/or examples for the synthesis of compounds over a sufficiently representative range, but only provides biological data for a very limited subset of compounds, such that there is considerable doubt as to whether the activity is present for the whole range claimed.  

Where the compounds per se are claimed without reference to the activity, the claims will be enabled where the specification provides sufficient information for the person skilled in the art to make the compounds over the whole scope of the claims.  (In this situation, examiners may need to consider whether the claimed compounds that do not have the activity satisfy the usefulness requirements of s18(1)(c)).  

Where the claims are directed to those compounds of the class that possess the relevant activity, and it is not reasonable to expect that all of the class will have the activity, the specification will only provide an enabling disclosure if:

  • it provides sufficient information for the person skilled in the art to make all of the compounds; and
  • it provides sufficient information to identify the compounds with the relevant activity without undue burden or the need for further invention.  (Each case must be determined on its merits – see Undue Burden and Broad or Speculative Claims).

Biotechnology

6. In Medimmune Ltd v Novartis Pharmaceuticals UK Ltd, Medical Research Council [2011] EWHC 1669 (Pat), broadly drafted claims encompassed methods for producing specific binding molecules, using phage display followed by recombinant production of binding molecules with the desired specificity.  The invention disclosed in the specification was a principle of general application (see Section 40 Enabling Disclosures).  At its core was a method for selecting a binding molecule of interest from amongst a potentially large population of other binding molecules.  The method did not depend on the precise identity of the binding molecule.  On the contrary, the method was useful since it could be applied to a diverse range of binding molecules, fragments and derivatives.  Neither did the method depend on the precise application to which it was put.  The disclosure of one application of the general principle enabled the full width of the claims, since implementation of the method for the purpose of a new application did not impose an undue burden on the skilled team.

Broad Claims

7. In DSM NV’s Patent [2001] RPC 19, a specification was found to impose an undue burden in respect of broadly drafted claims to DNA sequences.  The specification disclosed the gene sequence of a novel enzyme and taught that the addition of the enzyme to animal feed had beneficial effects.  The nature of the invention in this case was described in the specification as the microbial production of phytase.

The specification included claims to:

  1. A DNA sequence encoding a fungal phytase which catalyses the liberation of at least one inorganic phosphate from a myoinositol phosphate, said DNA sequence being selected from the group consisting of:
    (a) …  (b) …; and
    (c) DNA sequences hybridising at low stringency conditions (6X SSC; 50ºC overnight; washing in 6X SSC at room temperature) with a DNA fragment corresponding to a cDNA of the nucleotide sequence depicted in Figure 6 from position 210 to 1129.
  2. A DNA sequence which is related to the DNA sequence of claim 1 by the degeneration of the genetic code.

The stringency conditions in claim 1(c) were so low that the overwhelming majority of the DNA which appeared to bind in these conditions was not phytase DNA.  The Court found that the person skilled in the art seeking to implement the teaching of the specification in respect of claim 1(c), would be required to depart from the express teaching of the specification, to experiment over what might be a long period of time, and even then only possibly identify and isolate all of the sequences that fell within the scope of the claims.  This was found to impose an undue burden.

Claim 2 was wider than claim 1 and was not enabled, for the same reasons that claim 1(c) was not enabled.

8. In Genentech I/Polypeptide expression (T292/85) [1989] OJ EPO 275, the specification was found to contain an enabling disclosure of Genentech’s claims to a plasmid suitable for transforming a bacterial host, which included an expression control sequence to allow the expression of exogenous DNA as a recoverable polypeptide.  The Court considered that the general terms ‘plasmid’, ‘bacterial host’ and ‘exogenous DNA’ were each principles of general application.  Genentech had obviously not tried the invention using every plasmid, every bacterial host or every sequence of exogenous DNA.  However, the broad claim was fully enabled because the invention could be reasonably expected to work with anything that fell within the scope of each of these terms.  

Reach-Through Claims

9. ‘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.  If the relationship between the function of the compounds and their structural features is not defined, it would impose an undue burden if the person skilled in the art is required to:

  • isolate and characterise all compounds potentially falling within the scope of such claims, without any effective direction as to their identity; and/or
  • test every known compound and every conceivable future compound for the activity to determine whether it falls within the scope of the claim.  

The fact that the complete specification teaches how to test for the activity used to define the compounds does not necessarily mean that sufficient information is provided to constitute an enabling disclosure.  In fact, it constitutes an invitation for the skilled person to perform a research programme (see EPO decisions T 435/91 (Reasons 2.2.1) and T 1063/06 (Headnote II)).

Antibody Claims

10. The specification relates to the generation of antibodies that specifically bind to a new epitope (Epitope A).

Claim 1 to an antibody that specifically binds epitope A would be fully enabled where the applicant had disclosed the epitope and shown that antibodies can be raised against it.  This is because raising antibodies to that epitope is a principle that can be generally applied to produce antibodies over the whole scope of the claim.  The specification need only disclose one such antibody.  

Claim 2 to an antibody defined in terms of the six CDR sequences will be sufficiently enabled by the disclosure of the CDR sequences.  This is a relatively narrow claim.  The CDRs can be synthesised and inserted into the various antibody frameworks as a matter of routine.  

Claim 3 is to an antibody that specifically binds epitope A where the antibody comprises ‘one or more’ of six disclosed CDRs.  In general (each application must be considered on its merits), performing the invention over the whole scope of the claim would represent an undue burden.

Claim 3 encompasses a subset of the antibodies of claim 1, and many more antibodies than claim 2.  The disclosure of the epitope is not a principle of general application that can be applied to generate the antibodies in the claimed subset, to the exclusion of other antibodies not encompassed by the claim.  The skilled addressee is required to generate all of the antibodies of claim 1 and then perform the additional step of sequencing them to determine those that fall within the claimed subset.  This is more work than that required for claim 1 and would take longer than the skilled addressee would normally expect to take in raising antibodies.  Consequently, performing the invention defined in this claim would impose an undue burden.

Claim 4 is to an antibody comprising ‘one or more’ of the disclosed CDRs with no associated activity.  

In general, it would represent an undue burden for the person skilled in the art to determine all possible antibodies that fall within the scope of the claim and to produce them all.  This claim encompasses all of the antibodies of claim 3, and in addition all possible antibodies with ‘one or more’ of the 6 disclosed CDRs that do not bind epitope A.  The epitope is not a principle that can be applied to produce all of the antibodies claimed.  The skilled addressee would have to determine all possible antibody sequences that fall within the claim and make each one.  This would take much longer than the person skilled in the art would normally expect to take in generating antibodies, and would impose an undue burden.

For claims 3 and 4, the skilled addressee would possess the skills to perform the invention as claimed.  However, the time it would take to make every possible antibody having one or more CDRs falling within these claims, is longer than the normal expectation of the person skilled in the art given the nature of the invention disclosed in the specification, i.e. raising antibodies (see 5.6.7.2 Clear enough and complete enough disclosure s40(2)(a)).  

Note however, that this is not prescriptive.  What represents an undue burden depends on the facts of the case.  For example, if the specification relates to the production of a fully defined antibody library, the skilled addressee might expect to generate a large number of antibodies and then sequence them all.  

11. In Kirin-Amgen v Hoechst Marion Roussel Ltd [2004] UKHL 46; [2005] RPC 9, Lord Hoffmann observed obiter that the specification was insufficient.  In Australia, objections under s40(2)(a) and s40(3) would apply.  However, it should be noted that in this case the finding was only possible in retrospect, after Hoechst had developed their new method for recombinant production of erythropoietin.  

Amgen (the patentee) had in the late 70s to early 80s sequenced the human erythropoietin gene and expressed it as an exogenous sequence in a host cell.  In order to claim erythropoietin per se, which was known in the art, Amgen claimed recombinant erythropoietin in broadly drafted product by process claims, that were construed by the Court to encompass erythropoietin produced by any method involving recombinant DNA technology. 

Based on the knowledge of the gene sequence, Hoechst later produced an identical erythropoietin product by ‘gene activation’, i.e. by introducing expression control sequences upstream of the endogenous gene in a human cell.  Although their strategy was different, Hoechst’s product fell within the scope of Amgen’s product by process claims since its production involved recombinant DNA technology.  

The Court noted that the facts of this case did not support a broad claim based on the application of the general principle of using recombinant DNA technology to produce the protein.  Amgen’s patent only taught a method of expressing the gene by introducing the coding sequence into a host cell.  It did not provide any generic disclosure that enabled Hoechst’s gene activation method.  Furthermore, since it was a different method, Hoechst’s method did not constitute a version of Amgen’s process which, although untried, could reasonably be expected to work as well (Kirin-Amgen at [114]-[116]).  The claims therefore encompassed an embodiment that was not enabled and which owed nothing to the teaching of the patent or any principle which it disclosed.  

Methods of Treatment

Note: When examining method of treatment claims, issues of support should also be considered (see 5.6.7.3 Support Required for Pharmaceutical Inventions and Methods of Treatment​​​​​​​.  The principles provided in that part apply equally to methods of treatment of plants and any other organism).

12. A disclosure of the treatment of sugar beet seedlings, in the absence of any indication that the treatment was a principle of general application such that the skilled addressee would have a reasonable expectation that the treatment would work with any hydrated seedling, will not sufficiently enable a broad claim to:

‘A process for the treatment of hydrated seedlings which comprises subjecting the seedlings to cold shock at a temperature below 0°C for a period sufficiently long to affect the size of the resulting plant.’  

Similarly, where the description refers only to protecting tomatoes, cucumbers and potatoes against particular diseases, unless the specification teaches a principle of general application such that the skilled addressee would have a reasonable expectation that the treatment would work with any plant, an independent claim directed to a process for increasing the resistance of any plant to any disease or internal malfunction, by treating it with one or other of a number of specified compounds in an amount sufficient to increase the resistance, would not be enabled over its entire scope.  Where no general principle exists that would enable the treatment of any plant, the description must provide a sufficient range of examples, relating to different kinds of plants, to enable the skilled addressee to deduce how the process should be applied to virtually any plant.  

Where the claims are so broad as to claim methods of treatment that have not been enabled, the claims will also exceed the applicant’s contribution to the art.

Pharmaceutical

13. If a claim is to a ‘slow release’ formulation of a known drug, the specification must provide sufficient information to enable the person skilled in the art to produce a product having the desired characteristics, without embarking on a research program.

14. A claim relates to the use of an inhibitor of protein X to cure cancer Y.  If the specification discloses the principle that inhibition of protein X is all that is required to cure cancer Y, then it is reasonable to expect that the curative treatment will work with anything falling within the scope of the term ‘inhibitor of protein X’.  In this situation, the claim defining the inhibitor in general terms will be enabled over its whole scope, even where the applicant has only exemplified the use of one such inhibitor (see also Reach-Through Claims).

15. A claim related to the use of compound A or derivatives thereof for the preparation of a medicament for inhibiting organ or tissue transplant rejection in a mammal in need thereof.  The specification contained no disclosure enabling the skilled person to determine which of the many possible derivatives of compound A would have worked.  Although there was a strong possibility that some of the large number of derivatives would work in the same way as compound A, it was impossible to say which would work, unless the skilled person undertook the ‘vast and correspondingly burdensome’ research task necessary.  This would impose an undue burden.

16. The applicants filed their patent application, claiming amongst other things a vaccine.  It then took them several years to successfully produce a vaccine.  In this situation, since the applicants themselves had to undertake significant further research in order to produce something falling within the scope of the claim, the Court found that the complete specification did not disclose the claimed vaccine in a manner which enabled the vaccine to be prepared by the person skilled in the art (Chiron Corporation v Organon Teknika Ltd [1994] FSR 202).

Mechanical

17. The disclosure of an invention is not incomplete merely because the skilled addressee is required to make routine and non-inventive variation(s) to successfully perform the invention claimed.  For example, in an invention in which a switchable semi-conductor was used for switching electric circuits on and off without using contacts, residual current continued to flow in the circuit when switched off.  If this residual current adversely affected the use of the switch, and the person skilled in the art could modify the semi-conductor to overcome the residual current problem by routine techniques in a reasonable time frame given the nature of the invention, performance of the invention would not impose an undue burden.

18. A claim defines a radiation filter capable of filtering light of any wavelength. The description discloses a number of wide band filters that are known in the art to only work within the visual part of the spectrum.  Consequently, the disclosure does not provide sufficient information to enable the person skilled in the art to make the radiation filter over the whole scope of the claim.  However, if the description teaches new methods or principles that allow the application of the radiation filter to any wavelength of light, then the claims will be enabled by the disclosure.

19. A claim refers to a photovoltaic cell with ‘means for enhancing spectral response to wavelengths in a photovoltaic cell’ and ‘means for mitigating bulk recombination losses for the photovoltaic cell’.  Improving the spectral response to wavelengths and mitigating bulk recombination losses are both known problems in creating a photovoltaic cell.  The description outlines particular means of achieving these that are only applicable to certain types of photovoltaic cells comprising certain particular materials.  
The claims are therefore not enabled over their whole scope, as the principle disclosed in the description is specific in nature and is only applicable to a narrow class of photovoltaic cells.

20. A claim refers to a method of automatically enhancing the measurement precision of a distance measuring device, utilising a new general principle. The claims will be allowable if it is apparent from the description, or can be demonstrated by the applicant, that the new principle can be applied by the skilled addressee to any distance measuring device, using only routine methods of experimentation.  However if, on the balance of probabilities, the application of the principle to any distance measuring device would require the skilled addressee to carry out tests or developments that go beyond the routine or require additional inventions to solve problems not considered by the application, then the disclosure is not sufficiently enabling.

21. A claim comprises an equation defined in terms of a number of parameters, and defines the use of the equation in a calculation allowing optimisation of a switch mode power supply via a reduction in power dissipation.  However, the equation comprises several functions and constant terms which are not defined in the description and are not standard functions or constants that are known in the art.  Thus, the specification provides insufficient information to enable the skilled addressee to implement the claimed invention.

22. A claim defines a new type of closure for a nappy that ensures that the nappy cannot be undone by a baby or toddler. The claim is not restricted to any particular type of nappy or in the type of materials that comprise the nappy.

The description indicates that for the new closure to work, the closure and the nappy to which it is attached must comprise certain compatible materials typically found in disposable nappies. Cloth multiuse nappies are well known in the art and do not comprise these materials, as they are inherently unsuitable for use in an article intended to be used multiple times.  It is thus not apparent to the skilled addressee how the closure could be applied to multiuse cloth nappies.    

Since the closure is not a general principle that can be applied to all nappies and the specification does not teach alternative closures, the specification does not provide sufficient information to enable the skilled addressee to perform the invention over the whole width of the claim.  In addition, in claiming a closure for any type of nappy, the claim encompasses matter that is broader than is justified by the contribution to the art.

Computer-Related Inventions

23. The claims defined a computer-based system for planning, reporting and management which provided, amongst other things, facilities for directly booking travel in a computerised reservation system and having the booking communicated to a travel agency for processing and ticketing.  Evidence was filed by a third party establishing that the person skilled in the art following the teaching in the specification, would take years of design development and implementation work, and in addition, require creativity and ingenuity in the analysis and design of the system to implement the system as claimed.  

Support (Broader Than is Justified by the Contribution to the Art)

Some of the examples provided above to exemplify enabling disclosure, also exceed the contribution to the art, as is indicated.  

Chemistry

24. A claim relates to improved fuel oil compositions which have a desired property.  The description provides support for one method for obtaining fuel oils having this property, which is by the presence of defined amounts of a certain additive.  No alternative processes for obtaining fuel oils with the desired property are disclosed.  Prima facie, a claim that makes no mention of the additive is broader than is justified by the contribution to the art (and will not be enabled over the whole of its breadth).  Unless the applicant can provide evidence and/or credible and plausible submissions that it is not possible to envisage other ways of achieving that result which owe nothing to the teachings of the invention, the claim must be restricted.

Biotechnology

25. In Schering Biotech Corp’s Application [1993] RPC 249, the claims defined a process for producing a polypeptide with a desired activity, by expressing in a host cell either a specific deposited cDNA insert, or a nucleotide sequence capable of hybridising to said cDNA insert.  The ‘hybridising’ sequence was further defined in broad homology terms and encompassed a large number of possible sequences which would not all encode a polypeptide with the desired activity.  The judge observed that carrying out the claimed process with the ‘hybridising’ sequences may, or may not, produce a polypeptide with the claimed activity.  Consequently, he found that the application did not provide adequate support for a claim to the process using the ‘hybridising’ sequences (see also Reach-Through Claims).  

On the facts of this case, it is apparent that the ‘hybridising’ nucleotide sequences defined in the claims in general terms did not represent a principle of general application, since it is not reasonable to expect the invention to work with anything that falls within the general term.  The nature of the invention in this case was to produce a desired polypeptide by recombinant means.  In relation to the ‘hybridising’ sequences, the skilled addressee would be required to identify all possible sequences ‘capable of hybridising’ to the disclosed sequence and then determine which of these would encode a polypeptide with the relevant activity.  This would impose an undue burden, since it would take far longer than would normally be expected in the art to produce a recombinant polypeptide.  Consequently, insofar as they referred to the hybridising sequences, the claims were not enabled over their whole scope, and exceeded the contribution to the art disclosed in the specification.

Support (Inconsistency)

26. The description disclosed an article for conditioning fabrics in a laundry dryer, comprising a flexible woven or non-woven sheet having on it areas of fabric conditioning composition. A number of problems were identified in prior art conditioning sheets, including that they could block the air outlet causing the dryer to overheat. The applicant’s solution to this problem was to use a conditioning fabric that was air-permeable. It was clear from the description that air-permeability of the sheet material was not optional. It was necessary to the working of the invention, because without this feature the dryer could overheat causing damage or a fire. Thus, a claim to a conditioning sheet suitable for use in a laundry dryer without the feature of air permeability was not enabled and was consequently not supported by the description. (Glatt’s Application [1983] RPC 122 at 126-129)

27. A claim relates to a specified method of treating ‘synthetic resin mouldings’ to obtain certain changes in physical characteristics. All the examples in the description relate to the treatment of thermoplastic resins and the method appears inappropriate for thermosetting resins. In this situation, an objection should be taken that the specification has not provided sufficient information to enable the person skilled in the art to perform the claimed method insofar as it encompasses the treatment of thermosetting resins. Unless the applicant can provide evidence and/or credible and plausible submissions that the method is nevertheless applicable to thermosetting resins, the claim must be restricted to the treatment of thermoplastic resins.

Claims Supported Despite Apparent Inconsistencies

28. The application related to a 7-element digital display such as those used in service stations to display petrol prices, in which any required digit could be displayed using hinged flaps which covered/uncovered the elements. The example disclosed each flap attached to the baseboard by two studs, each retained in the base board by a coil spring and cotter arrangement which also retained the flap in an open or closed position by continuing to press on it.   
The claims were defined partly by the result to be achieved. The claimed digital display apparatus required (among other things) each flap to be attached to the baseboard by one or more studs with means for retaining the flap in an aperture in the baseboard “wherein spring means on the stud retains the associated flap in the first or second position”.    
The Court of Appeal (UK) found that it was not necessary to limit the claims to the exemplified two-stud attachment mechanism or the flap retaining means disclosed in the body of the specification. It found that the person skilled in the art would understand that (i) one or more studs could be used to attach each flap, and (ii) that different spring means could be used other than the coil spring and cotter arrangement explicitly disclosed in the specification, and as such these variations were implicitly disclosed. (A C Edwards Ltd v Acme Signs & Displays Ltd [1990] RPC 621 and [1992] RPC 131)
In the circumstances described above, the broadly drafted claim would be enabled over its full scope by the disclosure of the specification and the understanding of the person skilled in the art based on their common general knowledge, and would therefore be supported by that disclosure.