F. Hoffmann-La Roche AG v Bresatec Limited

[1994] APO 40

official notice

decision of a delegate of the commissioner of patents

Application        :    No. 632857 in the name of F. HOFFMANN-LA ROCHE AG

Title:    Purified Thermostable Enzyme

Action:    Request to amend a statement of grounds and particulars by BRESATEC LIMITED

Decision:    Issued            .

Abstract:    Amendment allowed

patents act 1990

decision of a delegate of the commissioner of patents

Re:Patent Application No. 632857 by F. HOFFMANN-LA ROCHE AG, opposition thereto by BRESATEC LIMITED, and a request to amend the statement of grounds and particulars

background

Application number 632857 by F. Hoffmann-La Roche ("Hoffmann") was advertised accepted on 14 January 1993.  On 14 April 1993 a notice of opposition was lodged at the Patent Office by Bresatec Limited ("Bresatec").  A statement of grounds and particulars was served on 17 May 1993 (and a three day extension of time subsequently allowed).

The time for serving evidence in support was extended without objection until 17 December 1993, and the service of evidence was completed on 17 December 1993.  A request to amend the statement of grounds and particulars was made on 23 December 1993.  The request was objected to by Hoffmann, and the matter was set down for hearing in Canberra on 10 May 1994.

Hoffmann elected not to attend the hearing, and filed written submissions instead.  Bresatec was represented by Dr Paul Wyk, patent attorney of APT Patent and Trade Mark Attorneys, Adelaide.

request to amend

The reasons for amending the statement of grounds and particulars given on the Request form were:

"Various clerical and grammatical errors have been found in the originally filed Statement of Grounds and Particulars.  On discussion with the declarants for the Opponent, Meera Verma, Renato Morona and Ian Burwell Dodd the new references included in the proposed Statement of Grounds and Particulars were uncovered."

The details of the proposed amendment are given later in the decision.

submissions

The patent attorney for Hoffmann made submissions in writing, which were filed by facsimile on the day before the hearing.  The submissions state in part:

"Bresatec Limited have attempted to amend the statement of grounds and particulars for two reasons, namely to correct clerical and grammatical errors and to introduce new references.

It is submitted that Regulation 5.9(1)(c) is the most pertinent sub-regulation 5.9 (sic) dealing with this instance, since (a) and (b) deal with amendments to the grounds of the opposition.

It is further submitted that introduction of these references is not an amendment to a particular."  [italics included in the original]

The submissions then summarise the following decisions without indicating the relevance of the decisions to the present request:  Diamond Scientific Company v CSL Limited (1992) AIPC 90-927, Abundant Lawn Grass Industries Pty Limited v Crancove Pty Ltd (1993) AIPC 90-973, Sumitomo Electric Industries Ltd v BICC PLC 26 IPR 613, Biosys v Ecogen Australia Pty Ltd 26 IPR 668, Metal Manufacturer's Limited v Cooper Industries Inc (1994) AIPC 91-051.

At the hearing, Dr Wyk made submissions on behalf of Bresatec which can be summarised as follows:

1.The present amendment is governed by regulation 5.9(1)(c):  amendment of the particulars must be allowed.  The caveat is contained in regulation 5.9(2)(e):  the amendment must not be allowed if a person would be unduly prejudiced.  In this regard, I was referred to the following Patent Office decisions:

the Diamond Scientific decision, supra;  the Metal Manufacturers decision, supra;  Borden Inc v Elkem A/S (1992) AIPC 90-893; the Sumitomo decision, supra.

2.The changes that are made are clearly amendments.

3.The statement of grounds and particulars should be given a purposive reading.

4.The new references do not anticipate the invention.  Instead, they relate to matters of common general knowledge.  The new references are not themselves part of the common general knowledge, but they provide specific examples to illustrate the matters that are asserted to be part of the common general knowledge.

5.Although details of the evidence of common general knowledge is not required in the statement of grounds and particulars, this material is being inserted so as to give a full picture of the case to be answered, and to ensure that the opponent is able to argue the material at the substantive opposition.

6.The clerical and grammatical errors are allowable amendments because they are either:
.  obvious typographical errors;  and

.  minor typographical omissions of journal references, which had not caused the applicant any confusion.

7.The new references were all identified during the month preceding 12 August 1993 as a result of the preparation of the declarations of Verma, Morona and Dodd.  The request to amend the statement was not filed until 23 December 1993 because it was decided to check whether any other amendments were necessary, and to make all the amendment at the one time.

decision

The present patent application was lodged under the provisions of the Patents Act 1952, and accepted under the provisions of the Patents Act 1990. The opposition is proceeding under Part V of the 1952 Act (by virtue of section 234(3) of the Patents Act 1990), and the applicable regulations are those made under the Patents Act 1990. Consequently, Chapter 5 of the Patents Regulations 1991 governs this action.

Hoffmann has suggested that the amendment proposed by Bresatec is not an amendment to particulars.  I presume that this submission is based on the fact that the request to amend was made on an official form number P/00/039 headed "REQUEST TO AMEND A PATENT REQUEST OR ANY OTHER FILED DOCUMENT (OTHER THAN A COMPLETE SPECIFICATION)".  This is the form that is used to request an amendment under section 104.  However, section 104 can only be used by "an applicant for a patent or a patentee" (section 104(1)).  Amendment of the statement of grounds and particulars is facilitated by regulation 5.9, and is initiated by "the written request of an opponent" (regulation 5.9(1)).  The request form filed by Bresatec states:

"We, Bresatec Limited of 39 Winwood Street, Thebarton, State of South Australia, Australia, hereby request that the Statement of Grounds and Particulars in respect of the Opposition lodged by us to the grant of a patent in respect of Application No. 632857 be amended as set out on the attached Statement of Proposed Amendments."

On receipt of this form the opposition clerk sent out the standard letter which states in part "The agent for the opponent lodged on 23 December 1993 an application under Regulation 5.9 to amend the Statement of Grounds and Particulars.".  The form filed provided all the information needed to make a request under regulation 5.9, and apparently did not mislead anyone as to the nature of the amendment.  In this situation, it is proper to give a purposive construction to the form (see Commonwealth Scientific and Industrial Research Organisation v HBH Technological Industries Pty Ltd 24 IPR 90 at pages 92 and 93). I am satisfied that I am dealing with an amendment to the statement of grounds and particulars under regulation 5.9.

The allowability of amendments to the statement of grounds and particulars is determined by regulation 5.9, which states:

"Amendment of statement

5.9  (1)  The Commissioner, on the written request of an opponent and subject to such terms as the Commissioner may specify:

(a)if the Commissioner reasonably believes that an amendment of a statement referred to in subregulation 5.4 (1) ("filing of statement") corrects an error or omission by the opponent or by his or her agent‑may amend the grounds of opposition set out in the statement; or

(b)if the Commissioner reasonably believes that an amendment of the grounds set out in a statement referred to in subregulation 5.4 (1) results from an amendment of a patent request or complete specification‑must amend those grounds; or

(c)must amend particulars relating to a ground referred to in subregulation 5.4 (1).

(2)  The Commissioner must not allow an amendment requested under subregulation (1), if:

(a)an application for dismissal of opposition is being considered; or

(b)an application for determination of opposition is being considered; or

(c)in the case of opposition under section 59 of the Act ("opposition to grant of standard patent")‑a specification relating to the opposed application is being re-examined; or

(d)he or she does not reasonably believe that the applicant has been notified of the proposed amendment; or

(e)he or she reasonably believes that a person will be unduly prejudiced by the amendment.

(3)  The Commissioner must give the parties an opportunity to make representations concerning the proposed amendment.

(4)  If the Commissioner allows an amendment, he or she must give the applicant a copy of the statement as amended."

In the present case the amendment relates only to the particulars and not to the grounds.  Further, there is no pending application for dismissal, an application for determination of the opposition is not being considered, there is no re-examination, the applicant has been notified of the proposed amendment and both parties have had an opportunity to make representations.  The only remaining issue that I must consider is whether I reasonably believe that "a person will be unduly prejudiced by the amendment" (regulation 5.9(2)(e)).

The issue of undue prejudice has been considered in many decisions of the Commissioner.  In the Diamond Scientific decision, supra, the Delegate of the Commissioner concluded that undue prejudice will occur if:

i)the amendment is detrimental or disadvantageous to the patent applicant;  and

ii)the circumstances surrounding the amendment cause the degree of that detriment or disadvantage to be unwarranted, excessive, improper, inappropriate or unjustified.

The amendment proposed by Bresatec has two components:  the rectification of "clerical and grammatical errors";  and the addition of new references.  It is easier to deal with each in turn.

1.  Clerical and grammatical errors

The amendments under the heading of clerical and grammatical errors appear to me to address two types of errors in the statement as originally filed.  Firstly, they correct certain obvious mistakes in the typing.  Secondly, they insert text where there is clearly something missing, although it is not obvious what was missing.

In the Diamond Scientific decision, supra, the Delegate considered the question of an obvious mistake at page 38,702:  "If the amendment can be categorised as correcting an obvious mistake then it seems to me that no person can be unduly prejudiced by that amendment."  I agree, and conclude that amendments to correct the first type of error are allowable.

The second type of error is illustrated by the following amendment (on page 7 as proposed to be amended, particular (m) (x);  new text is shown underlined):

"(x)"Enzymatic Synthesis of Deoxyribonucleic acid XIV Further purification and properties of deoxyribonucleic acid polymerase of Escherichia coli" by Richardson Journal of Biological Chemistry (1964) Vol 239 (1) 239:222"

The reference given in the original particular is clearly incomplete as the name of the journal is missing.  However, I do not believe it would be correct to say that the particular did not contain a material fact, but rather a material fact was provided with insufficient particularity.  In The Boots Company PLC v Hamilton Laboratories Pty Ltd, Patent Office decision, 21 December 1992, patent application number 614998, unreported, the Delegate commented on this situation at page 8 in the following terms:

"If a material fact was originally inadequately particularised, an amendment which merely clarifies what is already present does not change the case to be answered.  However, if a material fact was not originally present, then an amendment to introduce that fact is changing the case to be answered, and is prima facie prejudicial to the applicant."

I agree with this proposition, and consequently conclude that the amendments to correct these errors are also allowable.

2.  New references

In previous Patent Office decisions it has been stated that the insertion of new references will be detrimental to the applicant if, as a result, there is a substantial change in the case (as against the specific facts) to be answered (see Diamond Scientific decision, supra, and Abundant Lawn Grass decision, supra).

In the present case it has been asserted that the new references do not change the case to be answered because they are not new anticipations, but relate to matters of common general knowledge already included in the particulars.  It was not suggested that the references are themselves part of the common general knowledge.  Rather they are illustrations of the matters that are asserted to be common general knowledge.  In this regard, they are evidence that the fact is correct, not that the fact is part of the common general knowledge.

It is true that if an amendment inserts extra information about the common general knowledge, rather than raising new common general knowledge, it cannot be said to change the case, or the specific facts, to be answered.  However, this does not mean that amendments relating to matters of common general knowledge already raised in the particulars are not unduly prejudicial to the applicant.

The introduction of matters of evidence of common general knowledge was discussed in the Sumitomo decision, supra.  At page 620 the Delegate stated:

"Mark's Standard Handbook is introduced as an example of evidence that a matter is common general knowledge (as it is only "attention is drawn" to Mark's Standard Handbook).  Although it is accepted that particulars should not include evidence (Mobay Corporation v The Dow Chemical Company 24 IPR 379, see page 390), the question I have to decide is whether the introduction of these matters of evidence would unduly prejudice the patent applicant. The evidence does not change the case to be answered, but I believe it is prejudicial. The proposed amendment appears to limit the evidence of the common general knowledge to Mark's Standard Handbook.  However, the wording of the particular is such that the opponents are not restricted to Mark's Standard Handbook as evidence of the common general knowledge, and could choose not to rely on Mark's Standard Handbook at all.  As a consequence, it distracts from the real case to be answered.  Not only is this prejudicial, but it is unjustifiable."  [emphasis added]

The Delegate was of the view that on the facts of that case the particular drafting style adopted for the amendment made it appear that the evidence of common general knowledge was limited to the specific reference inserted by the amendment.  Consequently, it is necessary to consider the exact nature of an amendment, even if it relates only to matters of common general knowledge.

I will now look in turn at each of the new references.  This will require me to construe the statement of grounds and particulars.  In approaching this task I am conscious of the comments of Mason J in K & S Lake City Freighters Pty Ltd v Gordon & Gotch Ltd (1985) 157 CLR 309 at 315 on the importance of context:

"Problems of legal interpretation are not solved satisfactorily by ritual incantations which emphasise the clarity of meaning which words have when viewed in isolation, divorced from their context.  The modern approach to interpretation insists that the context be considered in the first instance, especially in the case of general words, and not merely at some later stage when ambiguity might be thought to arise."

a)  New references 1

The proposed amendment is to particular (e).  The relevant parts of this particular are as follows (new text is shown underlined):

"(e)Methods of providing estimates of molecular weights of proteins are highly variable and depend upon several factors including the shape of the protein and the methodology used to provide the estimate.  ...

The following literature gives some illustrations of large variations in the estimates of protein sizes that have been published:

(vi)  ...

C"Physical Characterisation and Simultaneous Purification of Bacteriophage T4 Induced Polynucleotide Kinase, polynucleotide Ligase, and Deoxyribonucleotide Acid Polymerase" van de Sande et al Biochemistry Vol 12 (25) 5045 (1973)

D"Effects of Heating in Dodecyl Sulfate Solution on the Conformation and Electrophoretic Mobility of isolated Major Outer Membrane Proteins from Escherichia coli K12" by Nakamura and Mizushima in J.Biochem vol 80 1411.

E"Cloning and Molecular Characterisation of the omp A Gene from Salmonella typhimurium" by Freudl and Cole in Eur J Biochem 134, 497 (1983)"

The wording of this particular makes it clear to me that the material inserted by the amendment illustrates the fact that molecular weight estimates are highly variable.  It is not explicitly stated that this fact is part of the common general knowledge.  It has been noted many times that the purpose of the Statement of Grounds and Particulars is to give the applicant notice of the case that they have to answer (for example, see Kent-Moore Corporation v Environmental Products (1992) AIPC 90-915 at page 38,625). This purpose can be achieved by using succinct language. In Borden v Elkem, supra, the Delegate said at page 38,446 that "to have the expectation that a Statement of Particulars should contain anything more than rudimentary details of the common general knowledge to be produced in the opposition would seem both unrealistic and unreasonable".  The Delegate in that case considered that the words "the prior art base in particular in relation to the binder system which is used" used in the particulars indicated that common general knowledge was asserted, and the area of the common general knowledge.

Particular (e) simply states "Methods of providing estimates of molecular weights of proteins are highly variable ...", and then provides illustrative examples.  It is reasonable to conclude that the fact is asserted to be commonly known, i.e. it is common general knowledge.  The new references seem to be additional illustrations of the common general knowledge.  The amendment does not cause any confusion as to the case to be answered (other than that already present), although I am not sure that it necessarily assists an understanding of the case to be answered.

b)  New references 2

The proposed amendment is to particular (j).  The relevant parts of particulars (i) and (j) are as follows (new text is shown underlined):

"(i) The substantial differences in at least one of the purification procedures between the disclosure of Kaledin et al (supra) as compared to that of the Patent Specification under consideration is the use of a DNA column by Kaledin et al (supra) and the use of Phosphocellulose column by the Patent application as a last sixth step.  The two methods are interchangeable with some minor differences in effect.  ...

(j)  That for an analogous DNA polymerase known as Pol 1 initially the method of purification included as a last step the use of a Phosphocellulose column see Jovin et al (1969) J Biol Chem 244:2996, and the use of DNA column followed see McClure and Jovin (1975) cited in Jovin et al (1975 supra) see also "The Private Life of DNA Polymerase 1" by Arthur Kornberg page 782 in Methods in Enzymology Vol 182 "Guide to Protein Purification" Edited by Murray P Deutscher, published by Academic Press."

The wording of this particular makes it clear to me that the material inserted by the amendment illustrates the fact that the processes referred to in particular (i) are interchangeable.  It is not explicitly stated that it is common general knowledge that the processes are interchangeable, but this seems to be a reasonable construction to place on the particular.  The amendment does not cause any confusion as to the case to be answered, although I am not sure that it necessarily assists an understanding of the case to be answered.

c)  New references 3

The proposed amendment is to particular (n).  The relevant parts of this particular are as follows (new text is shown underlined):

"(n) That the use of non-ionic polymeric detergents was common, and was one of several alternatives that would have naturally been tried.  In this regard attention is drawn to the following publications:  ...

(iii)"On the Stimulation of Viral DNA Polymerase Activity by Nonionic Detergent" by Wu and Cetta in Biochemistry vol 14 (4); 789 (1975)"

The wording of this particular makes it clear to me that the material inserted by the amendment illustrates what is said to be "common".  I believe that it is reasonable to construe this as meaning "common general knowledge" when read in the light of the surrounding text stating "and was one of several alternatives that would have naturally been tried".  The amendment does not cause any confusion as to the case to be answered, although I am not sure that it necessarily assists an understanding of the case to be answered.

d)  New references 4

The proposed amendment is to particular (q).  The relevant parts of this particular are as follows (new text is shown underlined):

"(q) Once a protein such as the present enzyme has been isolated and purified it is a relatively simple and largely routine matter to clone and sequence DNA encoding for it.  ...

Methods of the above type are found in the reference book by Maniatis et al (supra), and the book entitled "Genetic Engineering vol 7" edited by Setlow and Hollaender.

Reference in this regard is also made to the publication "Isolation, Characterization, and Expression in "Escherichia coli of the DNA Polymerase Gene from Thermus aquaticus" by Lawyer et al in J Biol Chem (1989) 264 6427 and the references cited therein pertaining to the methods used.

Reference is also made to
(i)  "Using Purified Protein to Clone its Gene" by John M Wozney page 738 in "Guide to protein Purification" Edited by Murray P Deutscher, published by Academic Press.

(ii)  "Molecular cloning and characterisation of cDNA sequences coding for rat relaxin" by Hudson et al in Nature Vol 291 14th May 1981 page 127

(iii)  "Chicken histone H5: selection of a cDNA recombinant using an extended synthetic primer" by Krieg et al Nucleic Acids Research Vol 10 (5) 1495 (1982)"

This particular asserts that cloning and sequencing are simple and largely routine.  It was stated by Dr Wyk that this should be read as equivalent to a statement that cloning and sequencing are matters of common general knowledge.  I believe that on balance this is a reasonable construction to place on the particular.  The specific references inserted by the amendment are headed "Reference is also made to".  This does not make it clear to me whether what follows is evidence of the common general knowledge, or illustrations of that common general knowledge.  However, from a reading of the particular as a whole it is apparent that all the references are directed to illustrations of the alleged common general knowledge, and the amendment does not cause any confusion as to the case to be answered, although I am not sure that it assists an understanding of the case to be answered.

e)  New references 5

The proposed amendment is to particular (s).  The relevant parts of this particular are as follows (new text is shown underlined):

"(s) At least claims 1 and 2 and claims dependent thereon, claims 34 and 35 and claims dependent thereon, claim 44, claim 46 to 48 and claims dependent theron (sic) do not comply with the requirements of Section 40 of the Patent Act (sic) that they are not fairly based, are not succinct, are ambiguous, because the claims are speculative or have a scope broader than can be supported by the disclosure.

The following examples are illustrative:  ...

(vi)That claim 46 encompasses any DNA sequence, even DNA sequence encoding the protein already isolated by Kaledin et al and Chien et al (supra) and any DNA sequence that has even remote homology with thermostable DNA polymerase from Thermus aquaticus.  Reference is made to the following publications

"An attempt to unify the structure of polymerases" by Delarue et al in Protein Eng. (1990) 3(6) 461

"Isolation, Characterisation and Expression Escherichia coli of the DNA Polymerase Gene from Thermus aquaticus" by Lawyer et al in J. Biol Chem (1989) 264 6427

"Molecular cloning and nucleotide sequence of the DNA polymerase gene from Thermus flavus" by Akmetzjanov and Vakhitov in Nucleic Acids Research vol 20(21) 5839.

"Rapid filter assay for the detection of DNA polymerase activity:  Direct identification of the gene for the DNA polymerase from Thermus aquaticus" by Sagner et al Gene 97 (1991) 119."

In order for me to determine whether the new references change the case to be answered, I need to appreciate the relevance of the references.  Particular (s) relates to section 40 issues.  The material facts for a section 40 ground of opposition were described by the Delegate in E.I. du Pont de Nemours and Company v Dowelanco, Patent Office decision, 5 April 1994, patent application number 626551, unreported, at page 17 in the following terms:

"a brief description of the specific subject matter causing section 40 not to be satisfied, a clear statement of the specific statutory requirement and the identification of the deficient part of the specification (by reference to page and line and/or claim numbers)."

Point (vi) of particular (s) states that the subject matter causing section 40 not to be satisfied is that some of the DNA sequences encompassed by the claim are known.  The point does not explicitly refer to a specific section 40 matter, although it appears that speculative claiming and/or fair basis is probably involved.  Claim 46 is identified as the deficient part of the specification.  Consequently, all the material facts are present.

The references appear to be provided as evidence of the material fact that some of the DNA sequences are known.  The addition of extra references does not change the case to be answered (the material fact is the same), but changes the specific facts of the case.

The fact that the new references could also be the basis of arguments that claim 46 lacks novelty is not relevant.  The particulars have not been raised with regard to the ground of novelty, and consequently cannot be argued on that basis.  The applicant is not confronted with a new novelty matter, only the existing section 40 matter.

f)  Conclusion

I consider that the addition of the new references would be of minimal detriment to the applicant, and would only marginally assist the applicant in appreciating the case it has to answer.

A final issue that I must consider is delay.  As the Delegate stated in the Diamond Scientific decision, supra, at page 38,698:  "Any delays in seeking a relevant amendment will unjustifiably hamper the preparation of the applicant's case in answer.  It follows, generally speaking, that if there is any unnecessary delay in seeking amendment of the statement to include extra particulars, the applicant (at least) will be unduly prejudiced if the amendment is allowed."  [emphasis in the original]

There is a noticeable delay between the time when Bresatec became aware of the new references, and the time when the amendment was proposed:

.all the new references were first identified during the month prior to 12 August 1993;

.the amendment was proposed on 23 December 1993;  and

.this equals a delay of four to five months in seeking the amendments.

Dr Wyk said that this delay was because Bresatec were waiting to see if there were any other changes needed, which would all be dealt with in one amendment.  In the end, no other changes were needed.  There does not appear to be a good reason for the delay of four to five months, but the detriment involved is small.  Overall I consider that the applicant would not be unduly prejudiced by the amendment.  Consequently, I must allow the amendment.

I should add that I am not sure that this sort of amendment is necessary.  I can appreciate that the opponent may be seeking to guard against the possibility that this material could be found to be inadmissible in the substantive opposition because it was not raised in the statement of grounds and particulars.  This would seem to be an extremely unlikely result when matters of common general knowledge are involved (see Metal Manufactures decision, supra, where unparticularised documents establishing the common general knowledge were found to be admissible as evidence).

costs

Although Bresatec are successful in the amendment, I consider that their delay in requesting the amendment disentitles them to an award of costs.  I make no award of costs.

conclusion

I allow the amendment.  The time for serving evidence in answer shall run from the date of this decision.

I make no award of costs.

S.D.Barker

Delegate of the Commissioner of Patents

Patent attorneys for the applicant  :  Spruson & Ferguson, Sydney

Patent attorneys for the opponent   :  APT, Adelaide