F. Hoffmann-la Roche AG v New England Biolabs, Inc

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: Opposition under section 104 of the Patents Act 1990 by New England Biolabs, Inc.

Decision: Issued

Abstract :
Amendments allowed. None of the amendments broaden the scope of the claims, claim matter not in substance disclosed in the specification as filed or introduce any section 40 problems. They are therefore all allowable amendments under section 102. The Commissioner has no discretionary power not to allow amendments which meet the requirements of section 102.

PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 632857 by F. Hoffmann-la Roche AG and opposition under section 104 thereto by New England Biolabs, Inc.

BACKGROUND

Patent application 632857 was filed in Australia on 8 October 1990 by Cetus Corporation as a divisional application of patent applications 77298/87 and 30629/89 both of which are now lapsed. Through these applications, priority is ultimately based on a number of US basic documents, the earliest of which was US 899513 (with a priority date of 22 August 1986). Cetus Corporation assigned their rights in the invention to F. Hoffmann-la Roche AG (Roche) on 11 December 1991 and the change of applicant was made in Australia under section 113 in March 1993.
The application was advertised accepted on 14 January 1993 and notices of opposition were filed by Bresatec Ltd and by New England Biolabs, Inc on 14 April 1993. The hearing was heard in Canberra on 27-30 May 1997 with the decision being issued on 12 November 1997.
As noted below, both parties appealed the initial decision but the opponent subsequently withdrew their appeal. The office decision was overturned with regard to novelty but not fair basis, and the matter was referred back to the Commissioner to deal with amendments to the specification prior to sealing. On 19 June 2000, the applicant filed a request under section 104 of the Patents Act 1990 to amend the patent application.
On 20 October 2000, the Commissioner granted leave to amend and this was advertised on 9 November 2000. A notice of opposition was then filed on 9 February 2001 by New England Biolabs (NEB) followed by a statement of grounds and particulars on 9 May 2001. Evidence in the opposition hearing was completed on 9 September 2002 and the matter set for hearing on 5 March 2003 in Canberra.
The opponent was represented by Mr Bruce Caine, SC assisted by Dr Michael Houlihan, patent attorney from Houlihan², Melbourne. The applicant was represented by Dr Annabelle Bennett SC assisted by Mr Stephen Burley of counsel, and Mr John O'Connor and Dr Martin O'Brien, patent attorneys of Spruson & Ferguson, Sydney.
CHRONOLOGY
I issued a decision on the substantive matter on 12 November 1997 (F. Hoffman La Roche AG v New England Biolabs Inc 97 APO 57 - which I will refer to hereafter as the original office decision) in which I upheld the opposition in relation to certain claims but rejected the opposition on the balance of the claims.
Both parties appealed the decision insofar as it was contrary to its interest. On 28 April 2000, in giving a ruling on the admissibility of evidence in the course of the Federal Court hearing, Emmett J expressed his views as to the nature of opposition proceedings by way of appeal under section 60 (see F. Hoffman La Roche AG v New England Biolabs Inc [2000] FCA 283 - decision 1). As a consequence of those views, New England Biolab discontinued their appeal [see F. Hoffman La Roche AG v New England Biolabs Inc [2000] FCA 1845 (15 November 2000) - decision 2]. However, this was after counsel for NEB gave an undertaking to apply to the court for revocation within 3 days after the grant of any patent [see F. Hoffman La Roche AG v New England Biolabs Inc [2001] FCA 787 (27 June 2001) - decision 3].
The Court has not yet made any orders on the applicant's appeal. In the original notice of appeal, the applicant had foreshadowed an application to the Court for orders directing amendment of the Specification and gave the Patent Office notice of such a motion on 16 May 2000. However, the judge in direction hearings following the discontinuance of the opponent, had tentatively expressed the view that he did not believe he had any power to direct amendment (see decision 2 - paragraphs 7 and 8).
The applicant abandoned their application in the court and instead filed a request to amend the specification under section 104 before the Commissioner on 19 June 2000. The opponent argued that the amendments should be processed after grant but the judge concluded that it was in the public interest in ensuring any amendment that might affect the validity of a patent should be made prior to grant (see decision 2 - paragraph 16).
As a consequence, any order to seal the patent was deferred until the section 104 amendments were finally dealt with. The examining delegate granted leave to amend on 20 October 2000 and this was advertised on 9 November 2000. New England Biolabs filed a notice of opposition to the amendments on 9 February 2001. They also appealed to the Federal Court under the Administrative Decisions (Judicial Review) Act ("the AD(JR) Act") seeking to impugn the Commissioner's decision to grant leave to amend on the grounds that the Commissioner's delegate failed to have regard to what the opponent regarded as "inequitable conduct" and did not use residual discretion to refuse the amendment. The Commissioner's decision to grant leave was upheld (see decision 3) with the Court concluding that the Commissioner had no discretionary power at the stage of granting leave to amend. As a result, the opposition on the amendments was free to continue.
After the amendments were advertised for opposition, and opposed, the applicant proposed further amendments to the statement of proposed amendments on 31 October 2002. These amendments withdrew the earlier amendments to pages 3 and 89 of the specification:
Page 3 was, by the 19 June 2000 statement, proposed to be amended to change reference to "pH 6.4" at original line 19 to read "pH 6.9" and also to amend the spelling of the word "template" on original line 16.
Page 89 was, by the 19 June 2000 statement, proposed to be amended to change the reference to "pH 6.4" at original line 14 to read "pH 6.9" and also to make various other changes to the text of page 89.
The applicant sought not to proceed with the amendments to the pH because they were unable to conclude that the pH references at page 3, line 19 and page 89, line 14 were incorrect. Further, the word "template" was in fact spelt correctly in the specification as originally filed and they did not seek to make that amendment. The applicant therefore withdrew all the amendments to page 3 and replaced the page 89 filed with 19 June amendments with a new page 89 filed on 31 October 2002.
The Deputy Commissioner advised on 11 November 2002 that while he did not accept the applicant's submission that the proposed amendments did not materially alter the section 104 request, he was prepared to proceed on the following basis to expedite matters, subject to the agreement of both parties :
·redo the granting of leave to amend, on the basis of the further statement of amendments;
·advertise those amendments as soon as possible
·by consent of the parties, agree that the presently filed opposition under section 104, together with all evidence filed therein, be taken as an opposition to the newly advertised amendments;
·set the hearing at the earliest convenient date; and
·in the event that a new party files an opposition to the proceedings, deal with that opposition separately as the need requires.
The parties agreed to the approach and the matter was set for hearing on 5 March 2003. Leave was granted to amend and advertised on 6 March 2003. No further oppositions were filed. The decision is based on the amendment request incorporating the changes filed on 31 October 2002.
SPECIFICATION
The specification as filed (and as accepted) relates to the polymerase chain reaction (or PCR) process which is a powerful tool in molecular biology enabling skilled workers to specifically amplify existing nucleic acid sequences. The technique involves denaturing a DNA test sample at a high temperature and then probing it with specific primers at lower temperatures. These primers are then extended at the lower temperature using an enzyme known as DNA polymerase. By repeating these steps in a cycle, the extension product of each primer then itself becomes a template for the production of the desired nucleic acid sequences. This results in an exponential amplification of specific nucleic acid sequences in a test sample.
It was generally recognised that a DNA polymerase which was able to withstand the high temperatures used in the PCR process would be able to improve that process. The invention in the current specification resides in the isolation of a DNA polymerase from a thermophilic (“heat loving”) strain of bacteria called Thermus aquaticus (which I will refer to hereafter as Taq DNA polymerase) which was stable in the temperatures used in the PCR process. The molecular weight of this polymerase was estimated to be 86-95 kD when compared to phosphorylase B on SDS-PAGE.
Prior to the first disclosure of PCR, there was little investigation on the isolation and purification of DNA polymerases from thermophilic organisms. The specification discusses 2 prior art references:
(a)Kaledin et al, “Isolation and Properties of DNA polymerase from the extremely thermophilic bacterium Thermus aquaticusYT1” Biokhimiya (1980) vol. 45, pages 644-651 (hereafter referred to as Kaledin)
(b)Chien et al, “Deoxyribonucleic acid polymerase from the extreme thermophile Thermus aquaticus” J. Bacteriol. (1976) vol. 127, pages 1550-1557 (hereafter referred to as Chien).
Both Kaledin and Chien isolated DNA polymerases from Thermus aquaticus but they described enzymes with apparently different molecular weights than the polymerase of the opposed specification. The applicant used the reported molecular weight differences to define the invention and to distinguish the claims from the prior art. Claim 1, for example, defines:
A purified thermostable DNA polymerase isolated from a Thermus species which catalyses combination of nucleoside triphosphates to form a nucleic acid strand complementary to a nucleic acid template strand, said polymerase having a molecular weight of about 86,000 to 95,000 daltons as compared to phosphorylase B by SDS-PAGE.
Claims 2-7 are dependent on claim 1 and add further features to the enzyme defined in this claim.
The specification as accepted ends with 101 claims. Claims 12-74, and 86-101 are all related (in some way) to the specific enzymes defined in claims 1-7:
·     claims 12-33 define methods of using the thermostable enzyme of claims 1-7 in processes involving PCR;
·     claims 34-52 define recombinant thermostable DNA polymerase enzymes (or DNA sequences encoding these) from Thermus aquaticus or which have the properties of these enzymes;
·     claims 53-65, 67-74 define methods of using the recombinant enzyme claimed in claims 47-52. Claim 66 defines products of the process of claims 53-65.
·     claims 86-101 are omnibus claims which refer back to the different aspects of the invention with reference to particular examples.
The remaining claims are not restricted to particular thermostable enzymes from Thermus species and relate to different aspects involved in providing purified, stable thermostable enzymes for use in PCR, in particular to:
(a)ways of overcoming the difficulty of long term storage of thermostable enzymes by storing DNA polymerase in a buffered solution containing one or more non-ionic polymeric detergents (claims 8-11); and
(b)alternative techniques to purify thermostable enzymes which relied on hydrophobic properties of the thermostable DNA polymerase or differential heat stability of a recombinant thermostable polymerase when expressed in a heat labile host cell (claims 75-85).
RELEVANT LAW
This opposition relates to the operation of section 102 of the Act, the relevant parts of which read:
(1) An amendment of a complete specification is not allowable if, as a result of the amendment, the specification would claim matter not in substance disclosed in the specification as filed.
(2) An amendment of a complete specification is not allowable after the relevant time if, as a result of the amendment:
(a)       a claim of the specification would not in substance fall within the scope of the claims of the specification before amendment; or
(b)       the specification would not comply with subsection 40(2) or (3).
(2A) For the purpose of subsection (2),
relevant time means:
(a)       in relation to an amendment proposed to a complete specification relating to a standard patent - after the specification has been accepted; …
(2B) …
(3) This section does not apply to an amendment for the purpose of correcting a clerical error or an obvious mistake made in, or in relation to, a complete specification.
I note that the only grounds for opposing an amendment under section 104 are in relation to section 102 and that the Commissioner has no discretion about whether to allow an amendment under section 104 which meets all the requirements of section 102.
AMENDMENTS
The amendment request under section 104 filed on 19 June 2000 (as amended by amendments on 31 October 2002) sought to:
a)replace pages 10-13, 19, 21,24, 36, 39,45, 49, 88, 99, 100, 102-105, 107, 108, 110-114 and 121-158 of the complete specification as accepted with pages 3, 10-13, 19, 21,24, 36, 39,45, 49, 88, 89, 89a, 99, 99a, 100, 102-105, 107, 108, 110-114 and 121-158 filed on 19 June 2000 and page 89 filed on 31 October 2002.
b)replace Figure 2 and 3 with replacement Figure 2 and Figure 3 filed on 19 June 2000.
Some of these amendments are in response to the original Australian Patent Office decision where I found the following section 40 problems:
(i) claims 8-11, 75-85 are not fairly based because the definition of “thermostable” provided in the specification is too broad;
(ii)claim 34 (and claims dependent thereon) do not define the invention because the word “part” in claim 34 has no size or functional limitations;
(iii)there were also typographical errors in claims 95-97 as accepted which should have referred to claims 90-94 rather than claims 79-83.
However, most of the amendments appeared to have been proposed to overcome problems found in a US decision on a family member (US 4,889,818) which has been held unenforceable because of misleading and "inequitable conduct". I only note this to explain the unusual nature and number of amendments being proposed. The reasons why an applicant proposes amendments is not relevant to the Commissioner's consideration under section 104. Section 104(1) allows an applicant to propose amendments for any purpose, and the grounds for opposing an amendment under section 104 are limited to considering the allowability of amendments under section 102.

DECISION

There are many amendments being proposed in the current section 104 request and the Statement of Grounds and Particulars alleged a number of deficiencies with them. However, in their evidence in support the opponent was able to narrow the dispute to a small number of key issues. The opponent advised at the hearing that they were not pursuing some of these issues - one of which was the alleged problems with the proposed pH changes to pages 3 and 89 which became moot with the 31 October 2002 amendments. With this advice, the matters of dispute between the parties became limited to 4 key issues which I will consider separately below.
1. The change in definition of the term "thermostable enzyme" on page 45 broadens the scope of claims 8-14 and leads to matter being claimed which was not in substance disclosed in the specification as filed
The opponent objected to the following changes on page 45:
"As used herein, the term "thermostable enzyme" refers to an enzyme which ~~is stable to heat and is heat resistant and~~ catalyses (facilitates) combination of the nucleotides in the proper manner to form the primer extension products that are complementary to each nucleic acid strand, and is stable to heat and is heat resistant to the extent that it would be effective for the amplification reaction described herein, ie., the enzyme does not become irreversibly denatured (inactivated) when subjected to the elevated temperatures for the time necessary to effect denaturation of double-stranded nucleic acids."
According to the opponent, the specification as filed requires that the enzyme be heat resistant and heat stable per se. In contrast, the amendment qualifies the term "heat resistant" so that the thermostable polymerase need only be sufficiently heat resistant to the extent that it would be effective for the polymerase chain reaction (PCR).
The opponent noted that the specification as filed admits that the heating conditions necessary for nucleic acid denaturation in PCR depend on the buffer salt concentration and the composition, length and nucleotide composition of the nucleic acids being denatured and that an enzyme may tolerate "higher temperatures.....as the buffer salt concentration and/or GC composition of the nucleic acid is increased". The opponent argued that there could be conditions where the temperature for denaturation was lowered and that this would effectively lower the standard by which enzymes can be classified as heat resistant. As a consequence, enzymes which were not captured by the unqualified term "heat resistant" are now included as a result of the amendment proposed (see Morona evidence in support, para 4.4).
The opponent was unable to provide any actual examples of enzymes which would be encompassed by the proposed claims as they have construed them which were not within the original claims. The argument is therefore at best a hypothetical one.
In any case, I note that the term "heat resistant" is a relative term in the art as no enzyme will ever be completely resistant to heat. If an enzyme is exposed to a high enough temperature for a sufficiently long enough period, it will eventually denature. As a consequence, the term "heat resistant" has to be understood in the context of the specification when read in light of the common general knowledge.
The specification as filed (page 46) indicates that a "thermostable" (ie heat resistant) enzyme must be able to tolerate PCR conditions and gives a typical range of those conditions:
"typically range from about 90 to about 105^oC for a time depending on the temperature and the nucleic acid length typically about 0.5 to 4 minutes."
Based on this, the term "heat resistant" would be understood by the skilled worker as an enzyme which was able to withstand these types of temperatures. While the specification admits that conditions outside this might be used for PCR, it does not suggest that an enzyme which would not normally be considered "heat resistant" would suddenly become so.
The qualification provided by amendment merely clarifies this and does not expand the original definition. The applicant's expert, Professor Wake considered the term as:
"when I read the patent application (unamended), I understand the primary use of the DNA polymerase described and claimed to be in the polymerase chain reaction (PCR). As the temperature typically used in PCR is approximately 95^oC, I understand the term "thermostable" to mean an enzyme that can withstand that temperature in PCR. That is how I understood the term "thermostable" in the Patent Application before amendment and that remains my understanding of the term in the amended Patent Application."

I therefore agree with the applicant that the term has not been expanded by amendment and find that the change in definition has not broadened the scope of any of the claims nor led to matter being claimed which was not in substance disclosed. In my view, the amendments to the definition of "thermostable" are allowable.
2. The amendment to change the tense and wording of examples V, VII, VIII, IX, XI and XIII introduced section 40 problems by removing a best method of performance, broadened the scope of the claims and resulted in the specification claiming matter not in substance disclosed.
In some of the proposed amendments to examples V, VII, VIII, IX, XI and XIII, the examples are amended so that results and method steps are expressed in the present rather than the past tense. This changed the emphasis of the examples from results actually obtained to results being predicted. In other words, the method is describing what could be done rather than what was done. The applicant conceded in their evidence that the method described in example XIII was never actually performed in the way described in the example (see the Sninsky declaration). The method was an amalgam of two different methods (both of which had been performed) and the applicant believed at the time that a combination of the two methods would be the best method of purifying the enzyme (see Sninsky at paragraph 3.4). By changing the tense of the example to the present, the applicant argued that this distinction is made clearer.
The opponent argued that the amendments meant that there was no longer a best method of performance. I do not accept this argument. The method as proposed to be amended is still the same as that originally filed, just expressed in a different tense. While it is unfortunate that the original example was written in the past tense (as this implied that the method steps were in fact performed in the order given in the example), there is no section 40 requirement for an applicant to have actually performed (or to indicate whether they have performed) their best method. Therefore, the changes do not affect the applicant's best method of performance.

Further, given that there are no substantive changes to the method steps, the method of example XIII will inevitably produce the same product both before and after amendment. As a consequence, there is no new matter being introduced into the specification by the amendment and the scope of the claims is not altered. The opponent argued (see, for example, Morona, evidence in support paragraph 4.26) that the skilled worker attempting to reproduce these protocols would approach the task much differently based on the altered perception of what might be done compared with what has been done. For example, each step would need to be more carefully scrutinised and evaluated before progressing to the next step, possibly leading to an altered product.
However, there is no evidence suggesting that a skilled worker would have any real difficulty in following the directions provided in the example regardless of the tense. In fact, in the substantive opposition, the opponent was clearly able to easily identify and isolate the claimed Taq polymerase from Thermus aquaticus using 17 different protocols. Given that rate of apparent success, I find it hard to believe the opponent's assertion that a skilled worker would have any difficulty with the method described in example XIII which appears to be quite similar to the other protocols. I therefore do not accept that the change in tense means that there are now full description problems in the specification.
The other suggestion in the opponent's evidence (Morona, evidence in reply, paragraph 4.7) was that example XIII might have omitted a key step (a DEAE-cellulose column). Even if this is correct, the problem existed in the specification as filed and is not "as a result of the amendment" as required by section 102(2). As a consequence, the alleged problem is not relevant to the question of allowability of the amendment under section 102(2).

In my view, the changes to the tense in the examples above do not contravene section 102(1) or (2) and are allowable amendments.

3. The amendments to Example XIII also changed the reported levels of purity of the enzyme produced in the example. This introduced section 40 problems, broadened the scope of the claims and resulted in the specification claiming matter not in substance disclosed

Example XIII, as filed, was the applicant's best known method of purifying the Taq enzyme as at the priority date. The opponent argued that some of the amendments being proposed to this example changed the reported levels of purity of the enzyme obtained by the exemplified method. Thus, instead of a single band being "expected" on a silver stained SDS-PAGE, there is the apparently less certain requirement that it "should be found". Adding the word "essentially" in respect of the single band purity at page 113, line 31 indicates that other minor bands could be present. Rather than containing no detectable nuclease activity, the pooled fractions are now only "substantially free of contaminating nuclease". The opponent argued that the described enzyme was now significantly different because of its changed level of purity. According to the opponent, this introduced new subject matter and affected the scope of the claims. It also meant that there was no longer a best method of performance.
I note that the applicant does not concede that levels of purity of the exemplified enzyme are altered by the proposed amendments. However, even if there are significant differences in the level of purity introduced with the amendments (as alleged by the opponent), I am not convinced that these differences result in new matter being claimed [section 102(1)] or in the claims being broadened [section 102(2)]. The opponent suggested that the changes in the level of purity were a concession from the applicant that their enzyme is less pure than originally thought and hence more similar to the Kaledin than previously admitted. I note that this is really an issue of novelty and not relevant to the question of allowability under section 102.

In any case, the claims as a whole are not distinguished from the prior art in terms of their level of purity, a point noted in the original office decision at page 11:
"As an aside, I note the possibility that the methods exemplified in the opposed specification (using a phosphocellulose column) might result in a purer DNA polymerase than was produced by either of the methods used by Kaledin and Chien (exhibit 5, figure 1 of Dr Dimond's declaration of 1 February 1996 may be some evidence of this) but this was not argued in the hearing or in the evidence and the claims of the opposed specification do not distinguish the Kaledin and Chien enzyme on the basis of relative purity"

Although the claims define a "purified" enzyme, the actual level of purity was not used as a distinguishing characteristic from the prior art enzymes. My view is that therefore the skilled worker would have construed the term "purified" in the claims broadly to mean "substantially pure". It is well understood in the art that proteins isolated from natural sources would never be completely "pure". In fact, in the substantive matter, both parties considered the Kaledin and Chien enzymes as "purified" even though there were clearly recognised contaminants in both these preparations. I therefore agree with the applicant's construction of the term "purified" to simply mean that the enzyme preparation does not contain contaminants which would detrimentally affect the ability of that enzyme to effectively to carry out the PCR process (see Wake declaration, Evidence in answer, paragraph 5.2). In my view, whether there were minor contaminating bands or low levels of contaminating nucleases in example XIII does not affect the claims as a whole as filed, which always encompassed such enzymes.

In addition, the specification as filed stated that the examples were not meant to limit the scope (ie: the claims) of the invention (see page 85, lines 19-23). Section 102(1) only precludes amendments which result in matter being claimed which was not in substance disclosed in the specification as filed. The definition of "claim" in schedule 1 of the Patents Act restricts the term "claim" when used as a verb "to claim in a claim". It follows that amendments which do not affect the scope of the claims will not result in new matter being claimed. In the current case, the fact that the applicant now resiles from their contention that the exemplified Taq polymerase isolated and purified was free of nuclease and other minor contaminants does not result in new matter being claimed as the claims were never limited to such preparations. The opponent argued that the changes to the purity levels in example XIII changes the scope of claim 86 as accepted (now claim 89 as proposed to be amended). This claim is an omnibus claim which refers directly to example XIII:
"Purified Thermus aquaticus DNA polymerase having a molecular weight of 86,000 - 95,000 daltons which enzyme is substantially as described with reference to example I or example XIII."
I do not accept this argument. It is well established law that the test of whether the claims are broadened by an amendment is applied to the claims as a whole, not to an individual claim and, as I concluded above, the claims as a whole have not changed. In any case, I would construe claim 86 (or claim 89 as proposed to be amended) as defining a polymerase produced by the method of examples I or XIII. The level of purity is an inherent characteristic of the product produced by the method. The fact that the example incorrectly reported its level of purity and seeks to correct that does not change the product which would have been inevitably produced if the method steps had been followed. While the skilled worker might have been surprised that the enzyme isolated by example XIII was not as pure as reported in the example, they could not alter the product to meet their expectations.

Given this, my view is that the product produced by example XIII would be the same before and after amendment and that therefore the amendments to example XIII do not affect either the best method of performance or the scope of claim 86 as accepted. As a result, I do not believe that the proposed amendments to example XIII contravene either sections 102(1) or (2) and the amendments are therefore allowable.
4. The amendment to remove reference to the Kaledin method of assay and replace it with a different assay in Example I introduced section 40 problems, broadened the scope of the claims and resulted in the specification claiming matter not in substance disclosed.
The effect of these amendments is to remove reference to the DNA polymerase assay method of Kaledin and replace it with a modified description of a method on page 89 of the specification which "may" be used.
The opponent argued that it was no longer clear how the polymerase assay was actually performed by the applicant and as a result:
·There was no valid comparison between the activity of the enzyme of the applicant's invention and the prior art of Kaledin.
·The skilled worker could no longer understand the invention described;
·It was unclear how the unit definition was calculated
I do not accept any of these arguments. The claims as a whole are not defined in terms of their specific activity and are not restricted to an enzyme having a certain specific activity. As a result, a change in the method of assay does not affect the scope of the claims as a whole. It therefore does not broaden the scope of the claims [section 102(2)] or result in claiming new matter not in substance disclosed in the specification as filed [section 102(1)]. The lack of a valid comparison between the activity of the enzyme of the applicant's invention and the prior art of Kaledin appears to be rearguing the issue of novelty which is irrelevant to the considerations of section 102.

The exact activity of the enzyme was also not important in order to be able to isolate the claimed enzyme. As a result, a change in the method of assaying for activity or an alleged clarity problem with how the unit definition is calculated has no bearing on the skilled worker's understanding of the invention and does not introduce any other section 40 problems. My view is that the change in the method of assay in example I is an allowable amendment under section 102.
CONCLUSION
I have found that the amendments proposed by the applicant do not broaden the scope of the claims, do not claim matter not in substance disclosed in the specification as filed and do not introduce any section 40 problems. As a consequence, all the amendments are allowable under section 102 and I therefore allow the amendments as filed on 19 June 2000 as proposed to be amended on 31 October 2002.
COSTS
In matters before the Commissioner, costs generally follow the event. I see no reason to depart from this practice in the current case. The opponent was unsuccessful in their opposition and I award costs against them.
Karen Ayers
Delegate of the Commissioner of Patents
Patent attorneys for the applicant : Spruson & Ferguson, Sydney
Patent attorneys for the opponents : Houlihan², Melbourne

[2003] APO 31

13 August 2003