Hoffmann-La Roche & Co v Labsystems Oy

[1992] APO 16

PATENTS ACT 1990

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Re:Appliction for a Patent Number 541099 in the name of F. HOFFMANN-LA ROCHE & CO AKTIENGESELLSCHAFT and Opposition thereto by LABSYSTEMS OY

Background

Hoffmann-La Roche, the applicant, lodged convention application number 541099 on 26 May 1982.  The application is entitled "A method for the detection of occult human blood in human stool samples".  Labsystems opposed the application under section 59 of the 1952 Act.
          After the parties had completed their evidence I heard the matter in Sydney where Mr J.G. Siely, patent attorney of Arthur S. Cave & Co, represented the applicant.  The opponent did not make an appearance but their attorneys, F.B. Rice & Co, consented that the hearing could proceed.
          Although the notice of opposition included all grounds available under sub-section 59(1) of the 1952 Act, the pertinent evidence related to the ground of non-compliance with section 40 of the 1952 Act.
Specification
          The specification relates to a method for the detection of occult human blood in human stool.  It states that the well known chemical test, based on the peroxidase action of haemoglobin, is non-specific because other stool components such as food and intestinal bacteria have peroxidase activity.  That test is therefore subject to false positive results.  It had been proposed, in the case of positive results, to carry out an immunological test

on an additional sample of the same stool.  However, this method has the disadvantage that the additional sample is not identical with
the sample subjected to the peroxidase test which again can lead to uncertainties.
          Page 3 of the specification states:

"Since the peroxidative method is carried out with the aid of an ethanolic peroxide solution, it has hitherto been the opinion that this method destroys the immunological properties of such components.

In contrast, it has now surprisingly been found in the scope of the present invention that this is not correct, but that it is readily possible to carry out in a stool sample, which has previously been subjected to the peroxidase method, an immunological detection for components of human origin which are not normally present in human stool."

Following this is a broad description of the invention in the form of a consistory statement which corresponds to claim 1 - and a description of specific features and two working examples.
          The specification ends with 10 claims.  Claims 2-10 are appended directly or indirectly to claim 1.  Claim 1 reads as follows:

"A method for the detection of occult human blood inhuman stool samples according to the peroxidase method, which method comprises, after having carried out the peroxidase method, immunologically detecting in the same stool sample a component of human origin which is not normally present in human stool."

Evidence-in-Support
          This evidence comprises declarations by Herman Adlercreutz, Paul Partanen and Donald Frommer.
          Herman Adlercreutz is a research professor and professor of clinical chemistry in Finland.  He states that hydrogen peroxide has a deleterious effect on the immunological activity of haemoglobin.  After mentioning that he has read the specification Dr Adlercreutz states:

"From my interpretation of the specification as a whole with reference to the example contained therein I believe the application to be directed towards a method for detecting occult blood in human stool samples characterized in the performance of an immunologically based test on the same portion of a stool sample which has been previously subjected to a peroxidase test.

I have read the main claim of the above referenced application and believe it to be directed to the detection of human occult blood in a human stool sample by a combination of the peroxidase and immunological methods mentioned previously.  From my interpretation of this claim I believe that the performance of the peroxidase test on one portion of a stool sample and an immunological test on another portion of the same stool sample would fall within the ambit of this claim.  As mentioned previously such a technique is well known in the art."

Annexed to this declaration is a paper entitled "Specific Non-Isotopic Immunoassay For the Detection of Occult Human Hemoglobin in Feces".  There is no mention as to whether the paper was published and if so when or where.  There is also an extensive Curriculum Vitae of Professor Adlercreutz.
          Paul Partanen is the Vice President of Research and Development at Labsystems Oy.  He states that he has read and considered the application.  Mr Partanen states that he has carried out tests on the effect of hydrogen peroxide on the immunological activity of human hemoglobin.  A copy of the protocol used in these tests and results obtained are exhibited to the declaration.  Mr Partanen states the following about these tests:

"From these results I believe that it is clear that when hydrogen peroxide is added directly to a stool sample containing hemoglobin, the immunogenicity of the hemoglobin is rapidly destroyed.  Therefore, I believe that after a short period of exposure of a human stool sample, containing hemoglobin, to hydrogen peroxide, immunological detection of hemoglobin in the said stool sample could not be reliably achieved."

Donald Frommer is a senior lecturer in medicine at the University of NSW and director of the St Vincents Hospital bowel cancer screening programme.  Dr Frommer states that he has read and considered the application.  He also states that he has conducted tests to determine the effect of hydrogen peroxide on the immunological detection of haemoglobin in faces, the protocol used and the results obtained in these tests are set out in the declaration.  Dr Frommer concludes his declaration by stating:

"From these results I believe that it is clear that when a faecal sample containing haemoglobin is exposed to hydrogen peroxide the ability to detect haemoglobin in this sample is greatly reduced.  Indeed it would appear that the level of immunologically detectable haemoglobin falls below the level of sensitivity of the radial immunodiffusion technique."

Evidence-in-Answer
          The applicant's evidence in answer comprises a statutory declaration by Harold Gallati, an employee of F. Hoffmann-La Roche.  Dr Gallati is the inventor of the invention the subject of the present application.
          Dr Gallati criticised the interpretation of the tests carried out by Mr Partanen and Dr Frommer.  He states that while their tests do show that the immunological activity of haemoglobin is diminished on treatment with hydrogen peroxide it is not completely destroyed and this is what the invention is based on.  He also stated that he refutes Dr Adlercreutz's allegation that claim 1 does not adequately define the invention described.
Evidence-in-Reply
          The opponents' evidence-in-reply comprises a declaration by William Pickering, technical assistant of    F.B. Rice & Co.  The declaration is mainly concerned with a discussion of the examiner's first report on the application and the applicant's response to tht report.  Exhibited to the declration are copies of the report, the response and a paper entitled "Immunological Detection of Fecal
Occult Blood" which is referred to on page 2 of the present specification.
Submissions
          At the hearing Mr Siely reiterated what Dr Gallati has stated in his declaration.  He said that the invention is predicated on a surprising discovery that ran contrary to the state of knowledge at the time, i.e. that it is possible to immunologically test human stool samples for components of human origin after those samples had been previously subjected to the peroxidase test.
          The specification did not only present an idea but also the manner of putting it into practice.  He further pointed out that Mr Partanen and Dr Frommer did not reply to Dr Galleti's answer to their declarations.
          Mr Siely submitted that the general thrust of much of the evidence insofar as it questions the ability of the invention to achieve what it purports to achieve goes to the subject of utility.  He pointed out that inutility is not a ground on which an opponent can rely under sub-section 59(1).
          On the point of the interpretation of claim 1 by Dr Adlercreutz Mr Siely submited that the claim is clear and does not include within its scope testing a separate sample.  He submitted that the phrase "detecting in the same stool sample" clearly refers to the stool sample in respect of which the peroxidase method has been carried out.  He further submitted that even if the language of the claim could be improved, the improvement would be so minor as to be only cosmetic.  Mr Siely pointed out that the other two declaratns for the opponent (Mr Partanen and Dr Frommer) had no problem interpreting the scope of the claim in the same way as Dr Gallati.

Decision
          The only section 40 issue raised in the evidence is a suggestion by Dr Adlercreutz that claim 1 does not adequately define the invention and that its scope could encompass the case where the peroxidase test is carried out on one portion of a stool sample and the immunological test is carried out on another portion of the same stool sample.  While in theory one can stretch the language of the claim to lead to this possibility I do not feel that there is any merit in this.  I agree with Mr Siely that the plain and more likely meaning of the expression "after having carried out the preoxidase method, immunologically detecting in the same stool sample" is that the latter test is carried out on the same stool sample as was previously subjected to the peroxidase test.  Further, in light of the discussion of the problems of the prior art and the description including the examples, this is the only construction possible.  Therefore I am satisfied that the claim adequately defines the invention and does not encompass the prior art.
          With regard to anticipation and obviousness the opponent has not cited any evidence, other than the admitted prior art, to suggest that the invention - as I understand it to be defined - is prior published, prior claimed, not novel or obvious.  On the contrary the evidence, which is consistent with the admitted prior art, establishes the belief that both tests could not be carried out on the same stool sample as it was throught that the peroxidase test destroyed the immunological properties of the components of human blood.  The invention as supported by the examples suggests that this belief is wrong.  The opponent did not challenge the examples or reply to Dr Gallati's evidence-in-answer.  Their evidence-in-support suggests that the ability to immunologically detect haemoglobin is reduced when the sample is exposed to hydrogen peroxide.  In any event the thrust of the evidence addresses the issue of inutility which, as Mr Siely rightly pointed out, is not an available ground for opposition under the Act.  Accordingly, I am satisfied, on the basis of the available evidence, that the invention claimed has not been anticipated and is not obvious.
          The opponent has not addressed the issue of manner of manufacture and none of the evidence goes to this subject.  I am satisfied that there is no basis for pursuing this topic.
Conclusion
          I have found that the claims adequately define the invention and otherwise complies with section 40.  I have also found that the ground of prior publication, lack of novelty, obviousness and manner of manufacture have not been established.
          Accordingly, I dismiss the opposition and direct that the application proceed to sealing, subject of course to any appeal.
     I award costs against the opponent Labsystems Oy.

(RAFIK EL-KILANY)
   Delegate of the Commissioner of Patents

Patent attorney for the applicant: Arthur S. Cave & Co, Sydney
Patent attorney for the opponent : F.B. Rice & Co, Sydney