2.23.8.2A Section 102(1) Examination Practice

Note: The information in this part only applies to:

•  requests to amend filed, or deemed under reg 10.6A to be filed, on or after 15 April 2013, for standard patent applications where a request for examination was not filed before 15 April 2013, and standard patents granted on such applications.

•  requests to amend filed on or after 15 April 2013 for innovation patent applications, and innovation patents where a request for examination was not filed before 15 April 2013, or the Commissioner had not decided before 15 April 2013 to examine the patent.

For all other requests to amend, see 2.23.8.2 Section 102(1) Examination Practice.

In this topic:

Note: Under sec 102(3), the provisions of sec 102(1) do not apply to an amendment for the purposes of correcting a clerical error or an obvious mistake made in, or in relation to, a complete specification (see 2.23.10 “Clerical Error” and “Obvious Mistake”), or to comply with the deposit requirements of sec 6(c) (see 2.7.5 Amendments to Insert Section 6(c) Information and Extensions of Time Therefor).

Overview

Amendment to any part of a specification is not allowable if the amended specification claims or discloses matter extending beyond the disclosure of the complete specification as filed in combination with the documents prescribed by reg 10.2A. The complete specification includes any claims, description, drawings, graphics, photographs, or sequence listings.

Further information on the meaning of sec 102(1) is provided in 2.23.8.1A The Section 102(1) Provisions Explained.

Examination Considerations

The correct approach when considering whether an amendment would result in the specification claiming or disclosing new matter is to ask whether the person skilled in the art would, on looking at the specification as proposed to be amended, learn anything about the invention which they could not learn from the complete specification as filed, in combination with the prescribed documents.  This comparison is a strict one in the sense that subject matter will be added unless it is clearly and unambiguously disclosed in the relevant documents when read in combination.  However, in considering the extent of the disclosure, examiners should have regard to the explicit and implicit disclosure of the specification as filed and other prescribed documents. Such an approach was recently affirmed in Commonwealth Scientific and Industrial Research Organisation v BASF Plant Science GmbH [2020] FCA 328 (“CSIRO v BASF”) at [14] and [215]-[218].

For example, it is permissible to add a feature to a claim if it simply excludes protection for part of the subject matter claimed and does so in a manner that does not add new subject matter.  However, if an amendment would lead to the specification claiming and/or disclosing an invention which is fundamentally different from that disclosed in the specification as filed and other prescribed documents, the conclusion can only be that it adds new matter, contrary to sec 102(1), and is therefore not allowable (consistent with the Full Court in AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99 at [244]-[247]).

Note: Objections that a proposed amendment is not allowable under sec 102(1) must include a reasoned explanation justifying this conclusion (see Reporting on Amendments Not Allowable Under Section 102(1) below).

Reporting on Amendments Not Allowable Under Section 102(1)

Where, as a result of a proposed amendment, the specification would claim or disclose matter that extends beyond the combined disclosure of the complete specification as filed and other prescribed documents the report should indicate that the proposed amendment is not allowable under sec 102(1) and provide a reasoned explanation.

Where an amendment proposed before or during examination is not allowable under sec 102(1), examination should only be conducted to the extent possible on the claims that define allowable subject matter.  No examination is to be conducted with respect to claimed matter that extends beyond the combined disclosure of the specification as filed and other prescribed documents.  Where only certain claims are examined, the report should clearly indicate which claims have been examined and include a statement that opinion is reserved in respect of those claims not examined.

This is illustrated in the example below, where a proposed amendment results in the claiming of component B, which was not disclosed in the specification as filed.

Claim 1.  Composition containing A and a solvent.

Claim 2.  Composition containing A or B.

Claim 3.  Composition containing B.

Examination would be carried out on claim 1 and claim 2 in so far as it relates to a composition containing only A.  Opinion would be reserved with respect to claim 2 in so far as it relates to a composition containing only B and claim 3.

Circumstances

Removing or Creating Ambiguity by Amendment

Existing ambiguity may be overcome by amendment, provided it is not resolved in such a manner as to add new matter to the specification that extends beyond what the skilled addressee could directly derive from reading the complete specification as filed, together with other prescribed documents.

Where an amendment would introduce ambiguity into the specification where there was none previously, examiners should consider whether the ambiguity arises as a result of the addition of new matter to the specification.  If so, the amendment will not be allowable under sec 102(1).  If the amendment does not add new matter, and it is filed before acceptance, then during examination of the application a clarity objection should be raised on the basis of the ambiguity.  After acceptance, an amendment that would result in non-compliance of the specification with sec 40(2), sec 40(3) or sec 40(3A) is not allowable under sec 102(2); see 2.23.9.6 Allowability Under Section 102(2)(b).

If the amendment itself is ambiguous, then an objection should be directed to the amendment.

Note: Where the complete specification includes a term which is indefinite and not exemplified, that term may be given the meaning that the person skilled in the art would have understood it to mean at the priority date, based on the common general knowledge in the art.

Amendment of Integers, Examples, Embodiments etc

A specific integer or specific example is not necessarily a disclosure of a generic class of which it is a member.  For example, where the specification contains a broad reference to a “means” for carrying out a function, but the description provides a dictionary defining the “means” or provides an explicit restriction of the “means” to a specific component, an amendment to the specification to add material inconsistent with the narrower meaning would not be allowable.  

Moreover, a proposed amendment which adds further embodiments, examples or illustrations to the specification will not be allowable under sec 102(1), if it adds new matter to the specification that extends beyond what the skilled addressee could directly derive from reading the complete specification as filed, together with other prescribed documents.

However if, for example, the specification as filed referred to tests having been carried out and the results of those tests, then amendments to add an example to this effect may be allowable.

Intermediate Generalisation

Where different embodiments of a specification disclose different features and it would not have been apparent to the person skilled in the art that the features of the different embodiments could be interchanged, then an amendment to interchange these features would not be allowable. This is referred to as intermediate generalisation and was discussed in CSIRO v BASF Plant Science GmbH [2020] FCA 328 (12 March 2020).

In determining whether an amendment results in an intermediate generalisation it is critical to consider whether the skilled person is being presented with any new information about the invention which is not directly and unambiguously apparent from the original disclosure.

Examiners should note that an amendment that which is directed to a subclass of the inventive concept, whether or not it is presented as inventively distinct in the specification as filed does not constitute an intermediate generalisation. For example, the elevation of features from dependent claims directed to such a subclass would not generally constitute an intermediate generalisation.

Clarifying Statements (Comprising, Common General Knowledge etc)

A proposed amendment may add clarifying statements, for example, a definition of the term “comprising”, or an indication that a reference to a prior art publication does not constitute an admission that the publication forms part of the common general knowledge.  Provided such statements do not add matter that extends beyond what the skilled addressee would understand from reading the complete specification as filed, together with other prescribed documents, the amendment will be allowable.

However, if the clarifying statement would result in the specification disclosing or claiming an invention that is fundamentally different from the invention disclosed in the specification as filed (and other prescribed documents), the amendment will not be allowable under sec 102(1) (see also Examination Considerations above).

Numerical Ranges

It is permissible to add a feature to a claim if it simply excludes protection for part of the subject matter of the claimed invention and does so in a manner that does not add to the combined disclosure of the specification as filed and other prescribed documents.  Thus, where a proposed amendment adds a numerical sub-range, which was not expressly stated in the complete specification as filed, consideration should be given to whether the sub-range extends beyond that disclosed in the specification as filed and other prescribed documents.

Each case should be assessed on its own merits.  Examiners should consider what is stated about the ranges; it is not merely a question of looking for any mention of the sub-range, but rather assessing the disclosure in respect of the ranges.  In general, where a proposed amendment to introduce a sub-range represents a choice from a number of alternative values in a broader range disclosed in the specification as filed, claims to the sub-range will not add new matter and the amendment will be allowable (see also Insertion or Amendment of Provisos below).  However, if the applicant submits, or the amendment states, that the sub-range is a selection from the broader range disclosed, and the body of the specification does not teach that the sub-range has any advantageous properties that would support such a selection, the amendment would add new matter contrary to sec 102(1).

Insertion or Amendment of Provisos

It is permissible to add a feature to a claim if it simply excludes protection for part of the subject matter of the claimed invention and does so in a manner that does not add to the combined disclosure of the specification as filed and other prescribed documents.  This is often achieved by way of a proviso.  

Where a proposed amendment adds a proviso that simply limits the scope of a claim to a subset of the original, the amendment will be allowable even where the subject matter of the proviso was not itself disclosed in the specification as filed.  For example, the specification and claims relate to the use of a specified pharmaceutical compound to treat cancer.  In response to an adverse report, the applicant proposes to amend the claims by adding the proviso that the compound is used to treat cancer, but not breast cancer.  In general, this type of amendment does not add new matter, even where breast cancer was not explicitly mentioned in the specification as filed.  This is because a broad disclosure of the treatment of “cancer” in the specification as filed would generally be considered to implicitly disclose treatment of any cancer, including breast cancer.  In this situation, the amendment would be allowable since the proviso simply narrows the scope of the claims to a subset of the cancers originally disclosed in the specification at its filing date (and other prescribed documents), and no new matter is added.  

However, if a proviso limits the scope of a claim to an invention that is fundamentally different from the invention disclosed in the specification as filed and other prescribed documents, the amendment will claim or disclose matter that extends beyond this disclosure and will not be allowable (see also Examination Considerations above).  For example, an amendment would not be allowable where it adds a proviso to define the meaning of a word or phrase in the specification, and that meaning would not have been apparent to the person skilled in the art reading the complete specification as filed and other prescribed documents.

Amending the Description (and/or Drawing(s), Graphic(s), Photograph(s), Sequence Listing) to Add Features Present Only in the Claims

Where a feature is clearly disclosed in a claim of the specification as filed, although not mentioned in the body of the specification (i.e. the description, together with any drawings, graphics, photographs and sequence listing), it is generally permissible to amend the description to add the feature.

Furthermore, where the description is directed to broad generalisations and the claims as originally filed are quite specific and provide detailed definitions of the invention broadly described, an amendment to the description to include specifically what was in the claims would, in general, be allowable.

However, a proposed amendment that inserts matter from the claims into the description (or drawings, graphics, photographs and/or sequence listing) will not be allowable where:

i. amended claims that were filed after the filing date of the application (e.g. amendments made under Article 34) are present in the specification; and

ii. those amended claims contain new matter which extends beyond the combined disclosure of the complete specification as filed and other prescribed documents; and

iii. the proposed amendment would introduce that new matter into the description (or drawings, graphics, photographs and/or sequence listing).

Matter From Article 34 Amendments

Applicants often seek to amend the claims of a PCT application during international examination.

Article 34 amendments are filed after the filing date of the PCT application and as a consequence are not part of the Australian complete specification as filed, nor are they prescribed by reg 10.2A.

However, Article 34 amendments filed during the international phase are deemed to amend the specification on the date those amendments were made (provided certain circumstances are met; see 2.20.10.1.1A General Provisions). Thus, amendments of this type must be treated as having been already incorporated into the specification when national examination commences.  Therefore, examiners are not permitted to object to the allowability of such amendments under sec 102 during examination, even if those amendments have resulted in claims which claim matter not in substance disclosed in the specification as filed (see also 2.20.10.6 Amendments Resulting in a Claim to New Matter).

Where Article 34 amendments include new matter not present in the specification as filed, or the other documents prescribed by reg 10.2A, a subsequent request under sec 104 to amend the specification to insert the new matter in the Article 34 amendment into the description (or drawings, graphics, photographs and/or sequence listing) will not be allowable (see Amending the Description (and/or Drawing(s), Graphic(s), Photograph(s), Sequence Listing) to Add Features Present Only in the Claims, above).  

Matter Described in Associated Provisional, Additional, Divisional or Parent Applications

Matter described in the following documents, but completely omitted from the specification of a complete application, is not part of the disclosure of “the complete specification as filed”.  Moreover, none of these documents are prescribed by reg 10.2A:  

• an associated provisional application;
• a Convention document;
• a parent specification or other ancestor;
• an additional to, or divisional of, the application.

Therefore, examiners should not have regard to the information in any of these documents when considering the allowability of an amendment under sec 102(1).

Matter from Documents Referred to in the Specification

For information on proposed amendments to insert cross-referenced material into the specification, see 2.11.3.7A Inclusion of References.

Translations

In the case of a national phase application where the original PCT application was filed in a foreign language, but a translation into English has been filed in order to enter the national phase in Australia, “the specification as filed” means the original foreign language PCT application and not the translation to which the foreign language application is taken to have been amended (consistent with Fina Research SA v Halliburton Energy Services Inc [2003] FCA 251, albeit that this case essentially deals with sec 102(2)).