National Research Development Corporation

[1988] APO 16

In the Matter of the Patents Act 1952 - and In the Matter of Application No. 24271/84 in the Name of NATIONAL RESEARCH DEVELOPMENT CORPORATION - and In the Matter of Examiner's Objections thereto.

DECISION OF A SUPERVISING EXAMINER OF PATENTS:

Background

Application No. 24271/84, which is entitled "Enhanced Luminescent or Luminometric Assay", was lodged on 8 February, 1984 in the name of THE SECRETARY OF STATE FOR SOCIAL SERVICES IN HER BRITANNIC MAJESTY'S GOVERNMENT OF THE UNITED KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND. The application is a Convention application based on two applications made in Great Britain which have dates of application of 11 February, 1983 and 20 April, 1983.The Commissioner directed that the application proceed in the name of the present applicant following a request made under s.34(4).

The examiner in the second report maintained objections to claims 2 and 9 to 15, therefore the attorney requested a hearing on the matter. The hearing was set down in Canberra on 25 November, 1987 and was attended by Mr. J. Slattery, patent attorney of Davies & Collison. At the conclusion of the hearing I allowed Mr. Slattery time to propose further amendments to the specification and time to obtain a substitute declaration. Mr. Slattery subsequently lodged a satisfactory declaration but the amendments he proposed did not overcome the major objection. Consequently it was then necessary to issue this decision.

The Specification

The specification, as presently proposed to be amended, relates to an enhanced luminescent or luminometric assay, particularly immuno assay, and to a diagnostic kit designed to facilitate the assay. The specification states that the majority of immuno assays employ a radioactive isotope as a label however radioactive isotopes have a number of major disadvantages. Some promising alternative labels are either substances which can themselves take part in a reaction resulting in the emission of luminescent light or substances which, on suitable treatment, produce compounds capable of taking part in a luminescent reaction. The sensitivity of luminescent or luminometric immuno assays depends on the light emitted in the luminescent reaction per unit of labelled material and one aim of the present invention is to provide a luminescent or luminometric assay with enhanced sensitivity because of an improved luminescent reaction.

The enhanced luminescent or luminometric assay is then described in similar terms to those found in claim 1. The specification then reads as follows:

"The present invention is based upon the surprising finding that the addition of certain readily-available phenols or naphthols to the known 2,3-dihydro-1,4- phthalazinedione/oxidant/peroxidase system, significantly enhances the sensitivity of the luminescent reaction produced.

In the present specification the term "enhanced" means that the total light emission of the present luminescent reaction and/or the signal/background ratio of the present luminescent reaction is greater than that achieved by the 2,3-dihydro-1,4-phthalazinedione/ oxidant/peroxidase system in the absence of sensitivity enhancer. Only those assays that incorporate a luminescent reaction that is so "enhanced" fall within the scope of the present invention."

Then follows a description of the preferred features of the assay. The invention also provides an assay kit for use in the enhanced luminescent or luminometric assay of the present invention. The luminescent or luminometric assay is then exemplified by several preferred embodiments.

Claim 1 reads as follows:

"1. A luminescent or luminometric assay wherein the chemiluminescent reaction is between a peroxidase enzyme, an oxidant, and a chemiluminescent 2,3-dihydro- 1,4-phthalazinedione, characterised in that the reaction is carried out in the presence of a phenolic compound of the formula:

The claim then particularises the functional groups which are possible for each of the substituents "A", "B" and "R" but this elaboration is irrelevant for the purposes of this decision, except I note that the claimed phenolic compounds appear to be well known.

Claim 9 reads as follows:

"9. A kit for use in a luminescent or luminometric assay comprising the following components in separate containers:

- a chemiluminescent 2,3-dihydro-1,4-phthalazinedione,

- a peroxidase enzyme, and

- a phenolic compound defined in claim I."

Claims 2 to 8 are dependent upon claim 1 and claims 10 to 15 are dependent upon claim 9. Claims 2 and 10, which are appended to claims 1 and 9 respectively, define the structure of the chemiluminescent 2,3-dihydro-1,4-phthalazinedione with a general formula, which includes several substituents. The functional groups which are listed as possible substituents in these claims include functional groups which can be substituted or unsubstituted, e.g. a substituted or unsubstituted amino group.

Objections and Submissions

The examiner in the first report stated that claims 2 and 10 were indefinite as to the precise nature and range of substituents envisaged by the word "substituted". The written response by the attorney submitted that those skilled in the art would know what kinds of substituents are appropriate. In the examiner's second report the objection to claims 2 and 10 was maintained for the reasons stated in the first report.

Mr. Slattery, at the hearing, said that the precise chemical structure of the chemiluminescent 2,3-dihydro-1,4- phthalazinedione was not an essential feature of the invention defined in claims I and 9. He also said that the relevant skilled person would understand the scope of the general term chemiluminescent 2,3-dihydro-1,4-phthalazinedione. Therefore he submitted that this same skilled person would have no difficulty with the term "substituted" in claims 2 and 10 because the scope of the substituted functional groups must fall within the scope of the general term chemiluminescent 2,3-dihydro-1,4-phthalazinedione. I agree with this submission.

The examiner's reports stated that the phrase "for use in", in claim 9 was a non-limiting term and also argued that this claim was redundant. The written response from the attorney argued that the phrase "for use in" is not descriptive surplusage but makes clear that the kit cannot include additional components inconsistent with the stated use. Mr. Slattery at the hearing argued that it was not possible to respond to this objection without knowing which other claim made claim 9 redundant. After careful consideration of all the claims I am unable to find another claim which has precisely the same scope as claim 9. Therefore claim 9 cannot be redundant.

The examiner's second report maintained an objection that claim 9 merely defines a collocation which does not have a novel feature and therefore this claim does not define patentable subject matter.

The relevant part of the written submission lodged on behalf of the applicant reads as follows:

"As to the collocation aspect of the objection, the chemiluminescent 2,3-dihydro-1,4-phthalazinedione (DPD) and the phenolic compound defined in claim 1 (the enhancer) and the peroxidase enzyme are chemicals which co-react when they are brought together for the assay. Since they are co-reactants, analogous to, say, the components of a glue, it is believed that paragraph 35.102 of the Patent Office Examiners' Manual applies here and therefore that the kit claim is allowable."

Decision

Mr. Slattery said that the phrase "for use in a luminescent or luminometric assay" taught the skilled reader of claim 9 that the normal use of this kit was in this assay procedure. Therefore he submitted that the kit defined in claim 9 was similar to the "glue packs" considered in paragraph 35.102 of the Patent Examiner's Manual. The relevant part of this paragraph reads as follows:

"35.102Difficulties may be experienced in relation to claims which define a package, container or the like, holding ingredients separately or in non-reactive admixture. Examples are:

(i) substances A and B will do nothing, but when mixed together will produce a glue or coating;

(ii) substance A is for treatment of a condition in humans (or other animals) and substance B is for alteration of a side effect caused by use of A.

Generally, if A and B are both known and there is no novelty in the construction of the package the claimed invention is not a true combination and consequently is not novel. However, there may be a potential working relationship where the components are to be used in a novel way and the construction of the package ensures they will be used in this way. Thus, where there is novelty in the sequential application of two compositions, a claim to a package of the two compositions so constructed as to ensure that in normal use such sequential application occurred would constitute a true combination. Some guidance with alleged inventions of this kind may be gained from the discussions in Unilever Ltd.'s Application, (1976) AOJP 531, and Blendax-Werke's Application, (1980) RPC 491."

The phrase "normal use" was used by Graham, J. in the judgement in the Blendax-Werke's case (supra page 506) however he did not conclude that a statement of use in a claim to a pack was sufficient to ensure normal use of the pack. In fact he decided that the claim to the pack which was before him should be amended to ensure either that the material was housed in a container which by its construction would in normal use ensure the required operation or, if there was no container, that the materials were so arranged relatively to each other that the required operation would similarly result from normal use. Consequently I consider that the kit defined in claim 9 is not analogous to the "glue pack" which is discussed in paragraph 35.102 of the Patent Examiner's Manual because the luminescent or luminometric assay does not require the components of the kit to be packaged in a particular way to ensure normal use.

In my view, the kit defined in claim 9 is similar to the prepreparation pack considered in the case of N.V. Phillips' Gloeilampenfabrieken Application (1976) AOJP 4475).

The claim considered by the hearing officer in the N.V. Phillips' case was a pre-preparation pack for producing a diagnostic preparation which comprised four components in separate containers.Mr. Slattery pointed out that the published decision did not refer to either the L'Oreal case (L'Oreal's Application 1970 RPC 565) or the Organon case (Organon Laboratories Ltd.'s Application 1970 RPC 574). Moreover he also said that the potential working inter- relationship of the separate components which is an important consideration in current Patent Office practice was not considered by the hearing officer. Consequently Mr. Slattery submitted that the decision in the N.V. Phillips' case was totally incorrect and it appeared not to be followed in the practice set out in paragraph 35.102 of the Patent Examiner's Manual.

The pack in the L'Oreal case consisted of two known ingredients in separate containers, which, when mixed together produced a known compound which had previously been used for another purpose. The pack in the Organon case consisted of two kinds of pills arranged on a card. Therefore I consider that the facts of the N.V. Phillips case can be distinguished from the facts of the L'Oreal and Organon cases. Consequently I think that it is of little relevance that the decision in the N.V. Phillips case does not refer to these earlier cases. I note that Mr. Slattery submitted that the kit defined in claim 9 could be distinguished from the packs considered in the L'Oreal and Organon cases.

An argument considered by the hearing officer in the N.V. Phillips' case (supra) reads as follows:

"The applicant has not disputed the Examiner's assertion that the reagents, per se, are known, but has argued that the interrelationship of the reagents leads to a new and useful method and hence the collocation of these reagents does amount to patentable subject matter."

This argument was discussed in the decision as follows:

"A more important difficulty is that whilst the elements of the pack can cooperate in the sense of chemically interacting together to produce the diagnostic preparation nominated in the claim, they are separate and distinct entities and not parts or characteristics of a single thing. Such a complex is not a manner of new manufacture and hence, a claim thereto is not valid."

Consequently I conclude that the hearing officer did consider the inter-relationship of the components of the pre- preparation pack in arriving at his conclusions. Therefore I consider that the decision in the N.V. Phillips' case does not conflict with current Patent Office practice.

Turning to the present situation, Mr. Slattery said that the separate and distinct entities which are defined in claim 9 are parts or characteristics of a single thing because there is a potential working interrelationship which produces a new or improved result, namely the luminescent or luminometric assay described in the present specification. Consequently he submitted that claim 9 does define patentable subject matter.

The phrase "potential working interrelationship" was used by Lloyd-Jacob, J. in the case of Cobianchi's Application (1953 RPC 199 at page 200) with respect to a pack of cards for playing "Canasta". His judgement, in part, reads as follows:

"If, however, the aggregation into a pack is not of a number of copies, but of a number of differently printed sheets which in their association one with another have a potential working inter-relationship, the aggregation possesses something more than the sum of its individual parts, although it is to be noted that this something more is but a potentiality which requires for its translation into actuality not only the full collection of the parts but a conception or plan for their use, for example, a card game."

It seems to me that the inventive concept of the present invention is the enhanced luminescent or luminometric assay which is, for example, defined in claim 1. Thus the components of a kit for use in this assay will have a potential working interrelationship if the claims to the kit are limited to the inventive concept.

I consider that the present claim 9 does not contain limitations which ensure that the components are used in the enhanced luminescent or luminometric assay, for example, limitations similar to those in the Blendax-Werke's case (supra). In my view, claim 9 defines a collection of chemicals which have been assembled in separate containers and which may be used in the luminescent or luminometric assay described in the prior art or the enhanced assay defined in claim 1. Therefore I think that the components of the kit defined in claim 9 are not limited to the present inventive concept. Consequently I consider that claim 9 does not define an aggregation of integers which have a potential working interrelationship, i.e. any more than any collection of chemical reagents.

Mr. Slattery argued that there was no reason why anyone should wish to make a kit of the materials claimed in claim 9 unless they had discovered the present luminescent or luminometric assay. In relation to this argument I note that the High Court in Gum v. Stevens (33 CLR 267 at page 270) agreed with the view expressed in the earlier decision of Tatham v. Dania that for an invention it is not necessary to merely show newness in the sense of doing a thing which has not been done before but it is necessary to show newness in the shape of novelty by producing a thing which requires some exertion of mind that could properly be called invention. The assembly of a number of known chemicals, each in a separate container, which is not novel, may be convenient for the performance of the enhanced assay but, in my opinion, does not require an exertion of the mind that could properly be called invention. Thus I am satisfied that the kit defined in claim 9 is not novel. I also note that the Australian applications which corresponded to those considered in Cobianchi's case (1959 AOJP 2133) and Organon's case (1974 AOJP 4503) were refused because the packs lacked novelty.

Mr. Slattery submitted that without a claim to the kit the applicant would not obtain full value for the present invention because it was difficult to take action against infringers of a method claim. However he conceded that the High Court (Wellcome Foundation Ltd. v. Commissioner of Patents 30 ALR 510 at page 515) considered that the difficulty of policing the patent was not sufficient justification for extending a patent monopoly beyond what is properly within the scope of the invention. However I note that the High Court in the Wellcome case (supra at page 516) also stated it is one thing to say that an inventor of a process is entitled to a monopoly in the product of that process but it is quite different to say that the inventor of a process is entitled to a monopoly in a substance which is used merely as an ingredient in that process. In the latter case the invention claimed makes no contribution to the manufacture of the substance and merely takes advantage of properties in the substance hitherto unknown or unsuspected. I think this statement also applies to the present three component kit. Therefore I consider that there is no justification for the present specification including claims to three known chemicals which are conveniently assembled together in separate containers.

Therefore I am satisfied that there are still lawful grounds of objection to application No. 24271/84 and I afford the applicant an opportunity to lodge a statement of proposed amendments to my satisfaction within the time remaining for acceptance.

(M. KENDALL)

Supervising Examiner of Patents

27 MAY 1988

Patent Attorney for the Applicant Davies & Collison