Novozymes A/S v DSM IP Assets B.V
[2005] APO 44
•11 October 2005
ABSTRACTS OF DECISIONS
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 736111 in the name of DSM IP Assets B.V.
Title: Expression cloning in filamentous fungi
Action: Opposition under section 59 by Novozymes A/S
Decision: Issued 11 October 2005.
Abstract
All of the claims as currently drafted lack fair basis because they omit the essential feature of measuring levels of activity of a protein of interest over the "background noise" of the parent strain. There were otherwise no section 40 problems identified in the specification. Because the claims omitted an essential feature of the invention, some of them also defined the prior art and were rendered not novel. The prior art also deprived most of the claims of their inventive step.
The opponent otherwise failed to establish that any of the claims lacked inventive step in light of the common general knowledge or were not for a manner of manufacture.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 736111 by DSM IP Assets B.V. and opposition thereto under section 59 by Novozymes A/S
BACKGROUND
1. Australian application 736111 in the name of DSM IP Assets B.V ("DSM") was filed on 22 December 1998 under the provisions of the PCT claiming priority from an earlier European application (97204079.4) which was filed on 22 December 1997. The Australian application was advertised accepted on 26 July 2001 and on 26 October 2001, a notice of opposition was filed by Novozymes A/S ("Novozymes"). Evidence in the opposition was completed on 21 September 2004 and the matter was set for hearing in Sydney on 11 July 2005.
2. Ann Kurts and Kathy Leviton, patent attorneys of Phillips Ormonde & Fitzpatrick, Sydney represented the applicant. Katrina Howard of counsel instructed by Jacinta Flattery-O'Brien, patent attorney of Shelston IP, Sydney represented the opponent. Peter Würtz Lindum also attended on behalf of the opponent.
SPECIFICATION
3. The specification as amended after acceptance relates to a method for the identification of DNA sequences encoding proteins of interest by expression cloning in filamentous fungi as hosts. The specification notes that expression cloning has previously been used for the identification of prokaryotic gene products in prokaryote host cells. However, there is a problem expressing eukaryotic genes in prokaryote cells and there is therefore a need to identify suitable eukaryotic cell hosts.
4. The specification noted that yeasts had previously been used as host cells. However these were known to have poor secretory capacity and cause hyperglycosylation of heterologous proteins. According to the specification, there is a need for an expression cloning system that would optimise the chances of detecting DNA sequences encoding eukaryotic proteins. The specification then described an expression cloning system in filamentous fungi. The method involved creating a DNA library in filamentous fungi by transforming the fungi using a vector containing a primary selection marker. These resulting transformants were then expressed and analysed for the specific gene of interest.
5. There was only one worked example of the full method (example 3). This example showed the construction of an initial cDNA library in E.coli using mRNA from Aspergillus tubigensis. The DNA from the E.coli library was then used to transform Aspergillus niger using a vector containing the amdS selection marker. Transformants were selected by their ability to grow on acetamide as the sole N-source. The resulting "master library" of transformants was then expressed and further screened for the gene of interest (xylanase). Xylanase activity was initially identified by a colony's ability to form clear halos on a detection plate which was otherwise turbid because of undissolved xylan. The xylanase-producing transformants were then further analysed for their levels of xylanase activity using fermentation experiments. The details of these experiments were not provided in the specification but the results were reported in table 1 on page 36. The parent strain had a background xylanase activity of 3 EXU/ml. In contrast, the most active transformant had an activity of 505 EXU/ml.
6. The specification then ends with 15 claims. The only independent claim is claim 1 which after amendment reads as follows:
A method for isolating a DNA sequence coding for a desired protein, said method comprising the steps of:
(a) preparing, in a suitable cloning vector, comprising a selection marker gene, a DNA library from an organism suspected of being capable of producing one or more desired proteins,
(b) transforming filamentous fungal hosts cells with the DNA library,
(c) culturing the transformed host cells obtained in (b) under conditions conducive to the expression of DNA sequences in the DNA library, and
(d) screening for clones of the transformed host cells expressing a protein with properties of interest by analysis of the proteins produced in (c), wherein the DNA sequence expressed in (c) does not complement the selection marker gene.
7. Of the remaining (dependent) claims, claims 2-10 define narrower embodiments of the process defined in claim 1, claims 11 and 12 define a process of producing a desired protein using the DNA sequence isolated from claim 1 and claims 13-15 are omnibus claims.
DECISION
What is the invention described in the specification?
8. Reading the specification at a broad level which discussed previous problems with prokaryotic libraries, it appears that the invention resides in the general concept of using DNA libraries expressed in filamentous fungi to identify a gene of interest. While it became clear from the evidence that the invention was not intended to be this broad, the applicant's specification and evidence were both poorly drafted and did not contain a clear statement of the applicant's actual invention.
9. The problem was made worse by the applicant's amendments to the claims during the evidentiary stages of the opposition. The amendments introduced a limitation into claim 1 that the gene of interest and the selection marker do not complement each other. This was ostensibly to overcome a novelty objection but as none of the citations disclosed the feature explicitly excluded by amendment, the limitation appeared completely unnecessary. The applicant acknowledged as much at the hearing.
10. The amendments were also technically confusing. The accepted claims defined a method containing two functionally distinct screening steps. The first screening step used a primary selection marker to generate a “master library” containing all transformants. The second screening step identified a specific transformant from within that library containing the gene of interest. In such a method, there is no need for the gene of interest to be complementary to the primary selection marker. In fact, as pointed out by the opponent’s expert (Professor Hynes), if the primary selection marker and the gene of interest were fully complementary, the genes could not be screened separately from each other rendering the claimed two step screening method useless. Even if the selection marker and the gene of interest were only partially complementary, there would be a large amount of unnecessary background which would limit the effectiveness of the claimed method. As a consequence, it seems likely that a skilled worker would avoid using a selection marker which complemented the gene of interest in the claimed method. It was therefore unclear why the applicant thought the exclusion necessary and what they intended to achieve by the amendments.
11. The confusion was further compounded by the applicant's expert (Dr Kelly). In her evidence in answer, she stated that the feature of "gene complementation" distinguished the amended claims from the prior art (see paragraphs 43, 44, 45 for example). Since the word "complement" was only introduced by the amendment, her arguments appeared to suggest that the amendment introduced a key distinguishing feature which (as noted above) is clearly incorrect. I do not know if Dr Kelly intended to suggest that the amendments were important and that her evidence was simply unclear or if she just inadvertently read a feature into the claims. Either way, I found her evidence particularly unhelpful in clarifying the issues of dispute between the parties.
12. As a consequence, prior to the hearing, I was unable to ascertain from either the specification or evidence what the applicant considered their invention to be over the prior art and I note that the opponent had the same problem. As a consequence, the critical issue for the hearing (and this decision) was for the applicant to properly identify their invention and for me to determine whether the claims actually defined it.
13. In their evidence in answer, the applicant had suggested that a key feature of their invention was that they "screened" for their gene of interest rather than "selected" for it. I note that the plain meaning of the term "select" is to choose. The term "screen" in the art merely means to look through a library to identify (or "select") a clone of interest. In other words, selecting means “to pick out” and screening means “to identify” (but not necessarily “pick out”). There is nothing in the specification which suggests that the terms have any different meaning and the specification even uses the two words in that context at page 1, lines 26-28:
"the cloning of novel protein components might therefore be considerably expedited by using a screening method involving selecting clones expressing a desired protein activity" (my emphasis).
14. At the hearing, the applicant explained that their concept of "selecting" a protein was determining whether a particular protein was present or not as a matter of fact – an "all or nothing" call. They intended the word "complementation" (which was used throughout their evidence) to convey the same principle. In other words, only the complete absence of the gene in the parent strain could be "complemented" by the presence of a gene of interest in a particular transformant.
15. In contrast, the applicant's concept of "screening" for a protein was determining the levels of activity of a particular protein as a matter of degree. Thus, the parent strain would have some background activity for a gene of interest and the applicant's method would allow the skilled worker to analyse the levels of activity of a genes of interest over the "background noise" of the parent. According to the applicant, being able to measure levels of activity (in a screening process) over the "background noise" rather than merely identify the presence of activity (in a selection process) was their actual inventive advance over prior art methods.
16. It is not possible to read these intended concepts from the plain meaning of the words “select” and “screen” themselves (as outlined above) nor can it be inferred from the specification itself (even with the hindsight benefit of the applicant’s explanation at the hearing). The specification did not provide dictionary definitions of either of the critical terms "select" or "screen" to explain the applicant's intended meanings. The specification also failed to specifically discuss the importance of measuring levels of activity, never acknowledged prior art attempts to express genes in filamentous fungi and did not mention the problem of "background noise".
17. The opponent argued that the "problem" with "background noise" reported by the applicant was not likely to be the result of a low level of enzyme activity in the parent strain but rather caused by a cross plate contamination where low levels of substrate are transferred when transformants were plated onto the new selection medium. This argument was only presented from the bar table and therefore I am unable to rely on it in my decision. In any event, while the opponent's explanation is entirely plausible, it does not rule out that the problem identified by the applicant might also exist. I therefore accept that the applicant’s actual invention is to overcome that problem by a “screening” process which can measure levels of activity of a gene of interest over the parent’s background levels of activity.
18. I note that this is a very difficult invention to define and there could be a large number of ways in which a claim could be drafted to encompass the intended invention. For the purposes of this decision, I have attempted to articulate the essential features of the actual invention in a similar format to the current claims to highlight the differences between the actual invention and the claims as currently drafted (with the differences shown in bold below). However, the steps as I have written them below are simply a way of conceptualising the actual invention and are not meant to be prescriptive in how the applicant should draft their claims. As the applicant has explained their actual invention, it resides in :
A method of isolating a DNA sequence coding for a desired protein, said method comprising the steps of:
(a) preparing, in a suitable cloning vector, comprising a selection marker gene, a DNA library from an organism suspected of being capable of producing one or more desired proteins.
(b) transforming filamentous fungal hosts cells with the DNA library;
(c) culturing the transformed host cells obtained in (b) under conditions conducive to the expression of DNA sequences in the DNA library, and
(d) screening for clones of the transformed host cells expressing a protein of interest by comparing the levels of activity of the expressed protein against the background activity levels of the parent strain and wherein the DNA sequence expressed in (c) does not complement the selection marker gene.
Section 40
fair basis
19. The key issue for fair basis is whether the claims as currently drafted encompass the essential features of the actual invention. Steps (a)-(c) of the claimed invention are the same as steps (a) to (c) of the actual invention outlined above. The difference is with step (d). The claimed step (d) requires that the transformants expressed in the claimed step (c) are "screened" for properties of interest by "analysis" of the proteins produced in (c). Given that the plain meaning of "screen" is to look through a library to identify a clone of interest, the claimed step (d) merely requires that the expressed clones are examined for properties of interest. This would include determining whether a protein was present or not (the "all or nothing test") by a selection test which the applicant has conceded is part of the prior art.
20. For the reasons given above, neither of the plain meanings of the terms "screen" or "analysis" convey the concept of measuring levels of activity of an expressed protein of interest against the background activity levels of the parent strain, which as outlined above is an essential feature of the actual invention. As a consequence, claim 1 (and claims 2-15 which are dependent on that claim) do not contain an essential feature of the actual invention. Hence, all of the claims as currently drafted lack fair basis.
clarity
21. The opponent argued that the limitation introduced by amendment where the DNA sequence expressed in (c) does not complement the selection marker gene made no technical sense and as a consequence, the claims were not clear. However, as I noted above, the problem with the amendment is that it appears unnecessary rather than it being technically incorrect. The opponent only had problems with the amendment when they tried to import a real limitation into the claims by attempting to use the amendment to distinguish the claims from the prior art. The opponent's discussion about the limitation being "nonsense" (paragraph 32 of their submissions) clearly indicates that they were able to construe and understand the nature of amendment. In my view, their problems with the amendment are properly dealt with under novelty rather than clarity and there are no issues of clarity which arise because of the amendments.
22. The opponent also argued that the method defined in the claims merely identified (rather than isolated) a DNA sequence and as a consequence the claims were unclear. While this might be technically correct, the opponent's expert had no difficulties in understanding the meaning or scope of claims and therefore, in my view, the problem does not affect the clarity of claims.
full description
23. I have serious concerns about whether the invention is fully described because (as noted above) it is not possible to construe from the specification what the applicant considers to be their actual invention. There is old patent law that suggests that a specification should not be a "puzzle". Given the above deficiencies, I expressed the view at the hearing that the current specification might fall foul of this old test. However, the opponent conceded that the findings in the recent High Court decision of Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 212 ALR 1 may have overruled this earlier test. Given this concession, I am prepared to give the applicant the benefit of doubt and find that the specification as filed discloses the actual invention (as outlined in paragraph 18 above) and therefore does not lack full description.
Novelty
24. The test for novelty is the "reverse infringement test" as set out in Meyers Taylor Pty Ltd v Viccar Industries ( 1977) 137 CLR 228 at page 235 where Aickin J stated:
"The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged invention would if the patent were valid, constitute an infringement."
Infringement is said to occur where "each and every one of the essential features of that claim have been taken" (Rodi and Wienenberger AG v. Henry Showell Ltd (1969) RPC 367).
25. The closest prior art relied on by the opponent was:
(a) Bergès et al "Cloning of an Aspergillus niger invertase gene by expression in Trichoderma reesei" Current Genetics (1993) volume 24, pp 53-59 (JFO-1);
(b) Yelton et al "A cosmid for selecting genes by complementation in Aspergillus nidulans: Selection of the developmentally regulated yA locus" PNAS (1985) volume 82, pp 834-838 (JFO-3);
(c) Verdoes et al "Characterization of an efficient gene cloning strategy for Aspergillus niger based on an autonomously replicating plasmid: cloning of the nicB gene of A. Niger" Gene (1994) volume 146, pp 159-165 (JFO-5).
26. Each citation showed the selection of a protein of interest from an expression library introduced into a filamentous fungus. JFO-1 constructed an Aspergillus niger DNA library in Trichoderma reesei using cosmid vectors containing the ura5 gene as the first selectable marker. The transformants were then further screened for a particular gene of interest (invertase) by expressing the recombinant genes and selecting transformants for their ability to grow on sucrose (suc+) as the sole carbon source.
27. JFO-3 constructed a cosmid library from a green-spored Aspergillus nidulans strain in a yellow spored Aspergillus nidulans strain using antibiotic resistance as the primary selection marker. Transformants were then screened for their ability to produce green spored colonies which might contain the gene of interest (yA).
28. JFO-5 constructed a library from Aspergillus niger by co-transformation with a fungal vector containing the autonomously replicating sequence AMA1. Original transformants were identified using the An pyrG gene selection marker. Genes of interest (either LysF or NicB) were then identified afterward by gene complementation using mutant strains.
29. All 3 citations show the construction of a DNA library from an organism containing the desired gene of interest using a suitable cloning vector with a selection marker gene. The resultant library was used to transform a filamentous fungus. The transformed host cells were then expressed under suitable conditions and certain clones were selected from the library by screening for the presence of a specific gene product (either invertase (JFO-1), yA (JFO-3), LysF or NicB (JFO-5). None of the specific gene products complemented the original selection marker. As a consequence, all three citations disclose each feature of claim 1 and render that claim not novel.
30. The three citations also explicitly disclose the gene product of interest being an enzyme, the host cell being Aspergillus niger, Aspergillus nidulans or Trichoderma reesei and a process for producing a desired protein in a filamentous fungi expression system. This means that each of the features of claims 8-12 is disclosed in the citations and therefore these claims lacked novelty in light of JFO-1, JFO-3 and JFO-5. JFO-5 also has the additional feature of using a cloning vector (AMA1) which is capable of autonomous maintenance in a filamentous fungal host cell. This disclosure deprives claims 5 and 6 of their novelty. The features of claims 2-4 and 7 and the omnibus claims (claims 13-15) are not explicitly disclosed in any of the citations and therefore those claims are novel in light of the prior art raised by the opponent.
31. The applicant argued that their invention could be distinguished from the prior art because the prior art merely selected for the presence of an enzyme in a transformant and did not attempt to measure the level of activity of the enzyme in their screening. According to the applicant, the prior art therefore relies on "gene complementation" to work where the gene of interest has to be completely absent from the parent strain for it to be detected in the transformant. I accept that the invention can be distinguished from the prior art in the manner suggested by the applicant. However (as noted above) the claims as currently drafted do not define this invention. The term "gene complementation" is not defined in the specification and is not present in the claims in the context of comparing the transformant with the parent strain. The claims also encompass any form of screening for the gene of interest which includes the selection methods of the prior art. As a consequence, the prior art deprives claims 1, 5, 6, 8-12 of their novelty as discussed above.
Inventive Step
32. At the hearing, the opponent constructed an inventive step argument in light of the common general knowledge alone based on statements which they had extracted from their expert's testimony. These statements were not made in the context of the ground of inventive step because their expert did not separately address this ground. In fact, there was no expert opinion before me which specifically challenged the inventiveness of any of the claims.
33. The opponent relied on an office decision in DSM NV v Novo Nordisk A/S [2001] APO 33 (19 July 2001) to argue that evidence would not be required if there was a clear cut case of obviousness or if there was no invention on the face of the document. However, I do not believe that this applies in the current case. Even though I accept that all of the features of claim 1 were part of the common general knowledge at the relevant date, there appears to be no clear motivation to combine the features in the way suggested in the claimed method. In particular, the opponent failed to explain whether the skilled worker would have recognised that the problems in the prior art would be overcome by the filamentous fungal expression system and why otherwise would the skilled worker use a filamentous fungi expression system over more traditional systems.
34. The onus lies with the opponent to prove their case in an opposition. Further, as per F. Hoffman-la Roche AG v New England Biolabs Inc. [2000] FCA 283 (28April 2000), the Commissioner should not refuse an application in respect of any claim on the grounds of lack of novelty or obviousness unless it was clear that the patent if granted would be clearly invalid. The opponent did not provide any expert evidence to challenge the inventiveness of the claims and as there is otherwise no manifest case of obviousness in respect of the claims, the opponent has therefore failed to establish that any of the claims lack inventive step based on the common general knowledge alone.
35. The opponent did not raise the issue of inventive step in relation to the 3 documents cited under novelty (JFO-1, JFO-3 and JFO-5). However, all three documents are extremely close citations and were from well-known and highly regarded scientific journals. I am therefore satisfied that all three documents are part of the prior art base for obviousness. The prior art was found to deprive claims 1, 5, 6, 8-12 (as currently drafted) of their novelty. For the same reasons, these claims also lack an inventive step in light of those citations.
36. Regarding claims 2-4 and 7, all these claims are directed to the broad problem of controlling the level of expression of the gene of interest in the filamentous fungal expression system defined in claim 1. Claim 2 defines the additional feature of a cloning vector with a homologous fragment to a pre-determined target locus. In my view, if a particular locus had the requisite expression levels being sought by the skilled worker, the skilled worker would directly be led to target that locus using homologous recombination as defined in this claim.
37. Claims 3 and 4 specify respectively that the predetermined target locus is a highly expressed gene and may contain more than one copy. However, if the skilled worker wanted to maximise expression levels for the gene of interest, they would obviously target a gene that was already highly expressed in the parent as defined in claim 3. The use of a target gene with more than one copy (as defined in claim 4) could also maximise expression of the gene of interest if there were two copies of the gene inserted in the genome. Even if the gene of interest was only inserted in one of the target gene sites, this would clearly be advantageous where the skilled worker needed to retain some target gene activity. Either way, it would be obvious to the skilled worker to target a gene with more than one copy (as defined in claim 4).
38. Claim 7 specifies that the sequence for the desired protein is linked to a particular promoter. However, the role of the promoter is to control the levels of expression. The skilled worker would automatically choose a particular promoter based on their desired levels of expression for the gene of interest. Given this, my view is that the additional features defined in claims 2-4 and 7 are simply obvious variations of claim 1 and that these claims therefore also lack an inventive step over the prior art documents cited by the opponent.
39. Regarding the omnibus claims 13-15, I construe these claims as being limited to the applicant’s actual invention (as outlined in paragraph 18 above). The method defined in claims 13-15 solves the problem of identifying an expressed protein where there is already a background level of activity of the protein in the parent strain. There is no evidence that this specific problem had been recognised in the prior art. There is also no evidence that a similar problem was known in a related art and solved in an analogous way to the claimed method. As a consequence, there does not appear to be any motivation from the prior art to the invention outlined in paragraph 18 above and hence my view (based on the evidence before me) is that that claims 13-15 are inventive.
Manner of Manufacture
40. The opponent argued that the claimed method was not a manner of manufacture because it failed the threshold test of inventiveness on the face of the specification (as per NV Philips Gloeilampenfabrieken v Mirabella Pty Ltd (1995) 183 ALR 655 and Advanced Building Systems Pty Ltd v Ramset Fasteners (Aust) Pty Ltd (1998) 152 ALR 604. The opponent argued that each of the steps of the claimed method was known. The specification does not assert that there is anything surprising or inventive about the particular combination of the known steps in the method claimed. According to the opponent, the method is a mere analogous use of an old technique.
41. I note that the specification acknowledges there to be advantages to using the filamentous fungal system. There is nothing in the specification which suggests that a person skilled in the art would be directly led to use that expression system compared to other expression systems. The steps of the method might all be known but there is nothing in the specification to suggest that they should be combined in the particular way claimed and there is also no suggestion in the specification to support the argument that the claimed method is a mere analogous use.
42. The opponent's argument under manner of manufacture is the same as they rose under inventive step and which I have already considered above. For the same reasons as I have given above, the opponent has failed to establish that the claims lack inventive merit based on the common general knowledge. As a consequence, all the claims define a manner of manufacture.
CONCLUSION
43. I have that found that all of the claims as currently drafted lack fair basis because they omit the essential feature of measuring levels of activity of a protein of interest over the "background noise" of the parent strain. There were otherwise no section 40 problems identified in the specification.
44. Because the claims omitted an essential feature of the invention, some of them also defined the prior art and were rendered not novel. In particular, claims 1, 5, 6, 8-12 lacked novelty over JFO-5 and claims 1, 8-12 also lacked novelty in light of JFO-1 and JFO-3. These claims also lacked an inventive step based on those citations. Claims 2-4 and 7 as currently drafted were found to be no more than an standard application of the processes disclosed in the citations and lacked an inventive step based on those citations. The omnibus claims (claims 13-15) insofar as they were limited to the applicant’s actual invention were found to be inventive.
45. The opponent otherwise failed to establish that any of the claims lacked inventive step based on the common general knowledge alone or were not for a manner of manufacture.
46. As I consider that there is still patentable subject matter in the specification, I allow the applicant 60 days in which to propose suitable amendments.
PROPOSED CLAIMS
47. At the hearing I asked the applicant if they had drafted any proposed amendments to the claims which they thought better defined the invention. The applicant provided three draft sets of claims in descending order of preference. Differences between the claims as currently drafted are marked in bold. The first set of alternative claims contained 15 claims all of which were dependent on a first proposed claim 1 which reads as follows:
first alternative claim 1
A method for isolating a DNA sequence coding for a desired protein, said method comprising the steps of:
a)preparing, in a suitable cloning vector, comprising a selection marker gene, a DNA library from an organism suspected of being capable of producing one or more desired proteins,
b)transforming filamentous fungal host cells with the DNA library,
c)culturing the transformed cells obtained in (b) under conditions conducive to the expression of DNA sequences in the DNA library, and
d)screening for clones of the transformed host cells expressing a desired protein by analysis of the proteins produced in (c), wherein the DNA sequence expressed in (c) does not complement the selection marker gene, and the host cells are not required to carry a genetic mutation complemented by the DNA sequence coding for the desired protein.
48. The second set of claims contained 13 claims all of which were dependent on a second proposed claim 1 which read as follows:
second alternative claim 1
A method for isolating a DNA sequence coding for a desired enzyme, said method comprising the steps of:
a)preparing, in a suitable cloning vector, comprising a selection marker gene, a DNA library from an organism suspected of being capable of producing one or more desired enzymes,
b)transforming filamentous fungal host cells with the DNA library,
c)culturing the transformed cells obtained in (b) under conditions conducive to the expression of DNA sequences in the DNA library, and
d)screening for clones of the transformed host cells expressing a desired enzyme by analysis of the proteins produced in (c), wherein the DNA sequence expressed in (c) does not complement the selection marker gene.
49. The third set of claims contained 15 claims all of which were dependent on a third proposed claim 1 which read as follows:
third alternative claim 1
A method for isolating a DNA sequence coding for a desired protein, said method comprising the steps of:
a)preparing, in a suitable cloning vector, comprising a selection marker gene, a DNA library from an organism suspected of being capable of producing one or more desired proteins,
b)transforming filamentous fungal host cells of the genera Aspergillus or Trichoderma with the DNA library,
c)culturing the transformed cells obtained in (b) under conditions conducive to the expression of DNA sequences in the DNA library, and
d)screening for clones of the transformed host cells expressing a desired protein by analysis of the proteins produced in (c), wherein the DNA sequence expressed in (c) does not complement the selection marker gene, and the host cells are not required to carry a genetic mutation complemented by the DNA sequence coding for the desired protein.
50. I can't comment on either the allowability of the amendments or whether they will ultimately be successful at a final determination. However, my initial view is that none of the proposed amendments have all the essential features of the actual invention which I have outlined above. Hence, prima facie, none of the proposed claims would overcome either the novelty or the fair basis problems identified in this decision.
COSTS
51. In matters before the Commissioner, costs generally follow the event and I see no reason to depart from this practice in this case. The opponent has been partly successful in their opposition and I therefore award costs against the applicant.
Karen Ayers
Delegate of the Commissioner of Patents11 October 2005
Patent attorneys for the applicant : Phillips Ormonde & Fitzpatrick, Sydney
Patent attorneys for the opponent : Shelston IP, Sydney
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