G 1/16 - The final word (?) about disclaimers
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T 782/16 - Can the content of a divisional be derived from an omnibus parent?
In this opposition appeal the Board had to assess if the opposed claims could be derived from the filed divisional and parent. In the Board's view, the "gold" standard for the assessment of Articles 123(2) and 76(1) EPC requires that the subject-matter of an amended claim (or of a claim of a divisional application) be based only on what the skilled person would directly and unambiguously derive from the application as originally filed (or from the earlier application; see G 2/10). For a correct application of this standard, a distinction needs to be made between subject-matter which is disclosed either implicitly or explicitly in the original (or earlier) application and therefore can be directly derived from it, and subject-matter which is the result of an intellectual process, in particular a complex one, carried out on what is disclosed. The Board concluded that the latter was the case.
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T 287/14 - Disclaimers: do not try this at home!
Amendments introducing disclaimers have probably led to more pain than joy. Disclaiming subject-matter in the application-as-filed usually is acceptable, but often has a high risk of lacking inventive step. Disclaiming subject-matter not in the application-as-filed led to G 1/03 already quite some years ago and is well-documented in many later decisions as well as in the Guidelines - strict conditions, which can basically only work out well if there is only one Art.54(3) EPC prior right document with a single, clear disclosure. Disclaiming embodiments in the application as filed led to G 2/10, which has a quite cryptically phrased headnote, but when read as a whole also gives very clear conditions -it usually is possible, as long as it is clear that something remains and that you do not sneakily change to a different inventive concept- and it is also well documented in the Guidelines. G 1/03 and G 2/10 relate to different cases, so cannot prima facie be considered as somehow conflicting, but Board 3.3.09 made the currently pending referral G 1/16 while handling appeal T 0437/14 asking a.o. whether the G 2/10 decision effects how some aspects of G 1/03 shall be interpreted. The current decision shows again that even of a disclaimer is made in good faith, it can easily be done wrongly and, as here, of the disclaimer is introduced before grant, one may all too easily end up in an inescapable Art.123(2)-123(3) trap... And the trouble was in this case actually not even in how the disclaimers needs to be drafted, but how novelty has to be assessed... which the opponent did correctly, but the examining division and the applicant/proprietor had not/did not... As to the aux requests, Art. 13(1) and 13(3) RPBA prevented further chances to remedy the trouble.
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T 1852/13 - Essentiality test vs. gold standard
The gold(en) standard?
This case concerns a divisional application in which a feature was removed from claim 1 with respect to claim 1 of the parent application, and whether such removal satisfies the requirements of Art. 76(1) EPC (and equivalently Art. 123(2) if it were to be performed as amendment).
This situation is dealt with by the 'essentiality test' of T 331/87.
This case discusses the essentiality test as it differs across its various versions (English original vs. German translation, original decision vs. guidelines), how it was applied in the recent past, criticism on the test including the criticism raised previously in T 910/03, and most importantly, how it fits into the 'gold standard' established by G 2/10.
After various deliberations, the Board considers the essentiality test to be dead: "Die Kammer ist zum Schluss gelangt, dass der Wesentlichkeitstest nicht mehr zum Einsatz kommen sollte", with one of the reasons being that the original phrasing of 'may not' in T 331/87 leaves open the possibility that all three conditions of the test are satisfied yet that Art. 123(2) is still violated.
As such, the Board considers that the essentiality test cannot replace the gold standard even in its specific application area (removal or replacement of a feature).
Is the essentiality test now finally dead? After T 910/03 it languished but occasionally reappeared.
The Board refrains from referring the matter to the EBoA as it considers such referral not to be decisive in the present case, since according to the Board a same conclusion would be reached using both the essentiality test and the gold standard (being that the removal violates Art. 76(1) EPC).
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Gold standard poll results
In T 437/14 the board of appeal referred questions on disclaimers to the enlarged board. The central question is how the gold standard of G 2/10 is to be squared with the disclaimers that are allowed for accidental anticipations under G 1/03. The case has been discussed in the comments, and various directions were suggested in which the enlarged board could go.
The past two weeks we placed a poll at our blog in which our readers could make their predictions. Polling is now closed and the results are in.
So there is a clear majority that does not expect that G1/03 is any in danger. I'm looking forward to the enlarged board's decision to see how well this poll matches reality.
The past two weeks we placed a poll at our blog in which our readers could make their predictions. Polling is now closed and the results are in.
So there is a clear majority that does not expect that G1/03 is any in danger. I'm looking forward to the enlarged board's decision to see how well this poll matches reality.
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T 437/14 - New Questions on Disclaimers referred to Enlarged Board
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| Is this still the same apple? |
The disclaimer case G 1/03 seems to allow exceptions to Article 123(2) that 'Gold-standard' case G 2/10 does not allow. This board does not like it one bit:
"If one takes a bite out of an apple, what remains is recognisably no longer the same apple as the original one. Even though it is still an apple, the apple with the bite taken out of it cannot be regarded as explicitly or implicitly, but directly and unambiguously, "disclosed" in the original apple." (Reasons 8.1)
Claim 1 in this case includes two disclaimers to restore novelty against an accidental anticipation. This would be allowed under G 1/03. Is it also allowed under the more recent G 2/10? We will soon have a new enlarged board decision on disclaimers, joining the ranks of G 1/03 and G 2/10, because the following questions have been referred:
1. Is the standard referred to in G 2/10 for the allowability of disclosed disclaimers under Article 123(2) EPC, i.e. whether the skilled person would, using common general knowledge, regard the subject-matter remaining in the claim after the introduction of the disclaimer as explicitly or implicitly, but directly and unambiguously, disclosed in the application as filed, also to be applied to claims containing undisclosed disclaimers?
2. If the answer to the first question is yes, is G 1/03 set aside as regards the exceptions relating to undisclosed disclaimers defined in its answer 2.1?
3. If the answer to the second question is no, i.e. if the exceptions relating to undisclosed disclaimers defined in answer 2.1 of G 1/03 apply in addition to the standard referred to in G 2/10, may this standard be modified in view of these exceptions?
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T 2523/11: attempt to voluntarily reduce scope of protection without support in application as filed
In opposition the patent was revoked because there was no support for a range of "0.2mm to 0.8mm diameter for warp and weft yarns". The patent application as filed has support for: "warp yarns having a diameter in the range of 0.20 mm to 0.80 mm and weft yarns having a diameter in the range of 0.20 mm to 1.0 mm". Thus, the proprietor reduced the scope of protection by giving up the diameter range from 0.8mm to 1.0mm for the weft yarns.
During the Opposition procedure the proprietor used G 1/93 to argue that the scope of protection of features without a technical contribution may be reduced without violating Art. 123(2). The Opponent and the Opposition Division did not share that opinion.
An appeal was filed with several requests in which the proprietor tried several strategies to overcome the A.123(2) and (3) problem. In the main request a correction of an obvious error was requested (change 1.0 to 0.8mm). In the auxiliary requests several variations of (undisclosed) ranges / values were requested. The outcome of the appeal procedure is that the scope of protection is now reduced to "infinitely small".
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T 1363/12 - Gold does not erode
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T 1441/13 - The difficulty of disclaiming
The examining division considered the claims not to fulfil the requirements of Article 53(a) EPC in combination with Rule 28(c) EPC - no EP patents shall be granted in respect of invention which at the filing date could exclusively be performed by use (involving the destruction) of human embryos for industrial of commercial purposes, including where the implementation of the invention presupposes such a destructive use to have taken place at some point in time before the filing date, whether or not this is described in the application (G 2/06). In appeal, the applicant tried to overcome the objection by introducing disclaimers in two auxiliary requests, but without success: the "remaining subject-matter" test of G 2/10 was not met, and/or the claims with the disclaimer lacked clarity.
Summary of Facts and Submissions
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VIII. Claims 1 and 5 of the Main Request read as follow:
"1. A method for obtaining polypeptide-secreting cells, comprising culturing pPS cells in activin A to differentiate the pPS cells to form gut endothelium, and culturing the gut endothelium in a mixture of islet cell differentiation factors comprising one or more of cyclopamine, betacellulin, exendin-4, glucagon-like peptide-1, hepatocyte growth factor, nicotinamide, IGF-1, n-butyrate, retinoic acid (all trans), growth hormone, placental lactogen, VEGF, IGF-II, IBMX, wortmannin, gastrin, cholecystokinin, NGF, EGF, KGF, PDGF, Reg or INGAP, thereby obtaining a cell population in which at least 5% of the cells secrete at least one of the following proteins from an endogenous gene: insulin, glucagon, somatostatin, and pancreatic polypeptide."
"5. A method of producing islet cells from primate pluripotent stem cells comprising
1) differentiating pPS cells to gut endoderm by culturing the pPS cells in a medium comprising activin A or retinoic acid;
2) differentiating the gut endoderm to a pancreas precursor by culturing the gut endoderm in a medium comprising a TGFß antagonist, a member of FGF family and EGF; and
3) differentiating the pancreas precursor to a mature islet cell by culturing the pancreas precursor in a medium comprising nicotinamide."
wherein "pPS" stands for "primate pluripotent stem". Claims 2-4 and 6-11 were directed to preferred embodiments of claims 1 and 5, respectively.
IX. Claims 1 and 5 of Auxiliary Request 1 were identical to claims 1 and 5 of the Main Request except for the following disclaimer at the end of both claims:
"... wherein said pPS cells are not obtained by means of a process in which human embryos are destroyed."
[..,]
X. Claims 1 and 5 of Auxiliary Request 2 were identical to claims 1 and 5 of the Main Request except for the following disclaimer at the end of both claims:
"... wherein the method does not involve use of a human embryo for industrial or commercial purposes."
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Reasons for the Decision
Main Request
1. The Main Request is identical to the request on which the examining division decided to refuse the present application.
Article 53(a) EPC, Rule 28(c) EPC
2. The method of claim 1 for obtaining polypeptide-secreting cells requires the use of a culture of primate pluripotent stem cells (pPS) which, according to the description of the application, includes human embryonic stem (hES) cells (cf. page 6, lines 19 to 20 of the application as filed). In the decision G 2/06 (supra), the Enlarged Board of Appeal considered that "(b)efore human embryonic stem cell cultures can be used they have to be made" and that, if the "only teaching of how to perform the invention to make human embryonic stem cell cultures is the use (involving their destruction) of human embryos, this invention falls under the prohibition of Rule 28(c) EPC" (cf. G 2/06, supra, point 22 of the Reasons). The Enlarged Board of Appeal further decided that the argument of the appellant that, for the assessment of patentability of these inventions, "all the steps preceding an invention for the purposes of Rule 28(c) EPC" should not be taken into account, was not relevant. Thus, the Enlarged Board decided that these steps had to be considered (cf. G 2/06, supra, point 23 of the Reasons).
3. At the relevant date of the patent in suit, the known and practised method for achieving cultures of hES cells, i.e. the starting material of the method of claim 1, included preceding steps that involved the destruction of human embryos. These destructive methods are not excluded from the scope of claim 1. Thus, in accordance with decision G 2/06 (supra), the board decides that the Main Request is not allowable under Article 53(a) EPC and Rule 28(c) EPC.
Admissibility of Auxiliary Requests 1 to 4 and of the new documentary evidence
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Auxiliary Request 1
8. Claims 1 and 5 of Auxiliary Request 1 contain a disclaimer that excludes methods involving the destruction of human embryos, reading: "... wherein said pPS cells are not obtained by means of a process in which human embryos are destroyed" (cf. point IX supra). This disclaimer intends to overcome the objection raised against the Main Request (cf. points 2 and 3 supra).
9. The criteria for allowability of disclaimers have been laid down in the decisions of the Enlarged Board of Appeal G 1/03 (supra, see in particular point 2.4.1 of the Reasons) and G 2/10 (supra). According to decision G 2/10 (supra), the subject-matter remaining in the claim after the introduction of the disclaimer must be - explicitly or implicitly - directly and unambiguously disclosed to the skilled person using common general knowledge, in the application as filed (cf. G 2/10, supra, Headnote answer to question 1(a)). In fact, this is "the overriding principle for any amendment to be allowable under Article 123(2) EPC ... that applies equally to the subject-matter of a claim the scope of which is determined by a disclaimer", be it an undisclosed or a disclosed disclaimer (cf. G 2/10, supra, point 4.7 of the Reasons).
10. In the present case, the subject-matter remaining in claims 1 and 5 of Auxiliary Request 1 after the introduction of the disclaimer, namely a method for obtaining polypeptide-secreting cells which includes the culture of hES cells derived only and exclusively from non-destructive methods, was not available at the priority date of the application (7 December 2001) and thus, was not directly and unambiguously disclosed to a skilled person as required by decision G 2/10 (supra). The board does not consider this "remaining subject-matter" to be disclosed in the application as filed. For the board to arrive at this decision, the following points are relevant:
10.1 According to the appellant, a single hES cell could be obtained from a human pre-implantation embryo by using methods developed in 2000 for pre-implantation genetic diagnosis (PIGD) of in vitro fertilised (IVF) embryos. Document Verlinsky et al. (2001) has been filed in order to show that a single blastomere cell could be obtained from day 3 cleaving embryos without destroying the embryo. This evidence allegedly supports the availability of hES cells at the priority date of the application by methods that do not involve the destruction of human embryos.
10.2 However, for carrying out the methods of claims 1 and 5, it is not enough to be in possession of single hES cells but it is further necessary to culture these cells in order to obtain an established culture of hES cells or a hES cell line, i.e. in vitro culturing and expansion of hES cells (derivation).
It is acknowledged that derivation methods of embryonic stem cells from mice and from some primates were known and available to a skilled person at the priority date of the application, as shown by the bibliographic references in the application as filed cited by the appellant (cf. page 6, third full paragraph and page 8, first and second full paragraphs of the application as filed). However, none of these derivation methods has been successfully used with hES cells.
Indeed, document Klimanskaya et al. (2006) states that the derivation of hES cells "currently requires the destruction of ex utero embryos" (cf. page 481, left-hand column, lines 1-2). Only by using a new method disclosed in this document, it was for the first time possible to obtain two hES cell lines (cf. page 481, right-hand column, last paragraph to page 482, left-hand column, first paragraph). In document Chung et al. (2008), this method is referred to as being highly inefficient (cf. page 1, middle column, first paragraph). Incidentally, Chung et al. (2008) also states that "(t)o date, the derivation of all human embryonic stem cell (hSEC) lines has involved destruction of embryos" (cf. page 1, left-hand column, lines 1-3).
10.3 It is worth noting that the derivation method disclosed in document Klimanskaya et al. (2006) is based on a co-culture of hES cells with green fluorescent protein (GFP)-positive hES cells (cf. page 482, left-hand column, first paragraph). The source of these GFP-positive hES is not mentioned in this document but, in view of the comments made in all these post-published documents (cf. point 10.2 supra), these hES cells were also obtained by methods involving the destruction of human embryos. It is thus only the derivation method disclosed by Chung et al. in 2008, seven years after the priority date of the present application (7 December 2001), which for the first time has allowed the provision of hES cultures (cell lines) without destroying a human embryo in any production step.
11. Appellant's further argument based on the public availability of established hES cell lines cannot be followed by the board, since these cell lines were also originally obtained using methods that, at some preceding step, involved the destruction of a human embryo (cf. point 2 supra, last sentence). This has not been contested by the appellant and there is no evidence on file to demonstrate the contrary.
In this respect, appellant's attention has also been drawn to decision T 2221/10 (supra) (cf. point V supra). In this decision, this board in a different composition considered methods using commercially or otherwise publicly available hES cell lines, including most of the hES cell lines referred to by the appellant in the present case (inter alia, Thomson et al., 1998). Although methods using these hES cell lines did not require de novo destruction of human embryos, the board concluded that all these hES cell lines were initially derived from a process which had destroyed human embryos.
Therefore, the board, following the criteria established in decision G 2/06 (supra), decided that "(i)nventions which make use of publicly available human embryonic stem cell lines which were initially derived by a process resulting in the destruction of the human embryos are excluded from patentability under the provisions of Article 53(a) EPC in combination with Rule 28(c) EPC" (cf. T 2221/10, supra, Headnote and points 10 to 29 of the Reasons).
Accordingly, the board dismissed the appeal against the decision of the examining division to refuse European patent application No. 03 751 238.1 claiming the priority dates of 7 October 2002 and 19 February 2003, i.e. almost one year after the priority date of the present application (7 December 2001).
12. Thus, the board does not accept appellant's argument that the application discloses a method for obtaining polypeptide-secreting cells which uses hES cultures or cell lines produced without involving the destruction of a human embryo, in a manner sufficiently clear and complete for it to be carried out - without undue burden or inventive skill - by a person skilled in the art. Rather the methods available to the skilled person at the relevant date all included, at some point in time, the destruction of a human embryo.
13. In view thereof, the board does not consider it necessary to examine whether the disclaimer introduced into claims 1 and 5 of Auxiliary Request 1 fulfils the other criteria established in decision G 1/03 (supra), such as for instance whether the disclaimer is complete, i.e. whether it actually excludes all subject-matter not allowable under Article 53(a) EPC in combination with Rule 28(c) EPC (see in this respect the disclaimer introduced into Auxiliary Request 2, points 15 to 17 infra).
14. In conclusion, the board considers the disclaimer introduced into claims 1 and 5 of Auxiliary Request 1 not to be allowable since the application as filed does not disclose the "remaining subject-matter" of the invention (a method which includes the culture of hES cells derived, only and exclusively, from non-destructive methods). Only with information available seven years after the claimed priority date, a skilled person would have been in a position to put into practice this "remaining subject-matter" (cf. point 9 supra).
Auxiliary Request 1 does not meet the requirements of Article 123(2) EPC.
Auxiliary Request 2
15. Claims 1 and 5 of Auxiliary Request 2 contain a disclaimer reading: "... wherein the method does not involve use of a human embryo for industrial or commercial purposes" (cf. point X supra).
16. Without entering into the question whether this disclaimer overcomes the objection raised against the disclaimer introduced into Auxiliary Request 1 (cf. points 10 and 11 supra), the board considers the disclaimer in Auxiliary Request 2 not to be clear and to be contradictory in itself. The fact that industrial protection is sought for the claimed subject-matter, i.e. a method comprising culturing pPS cells, already indicates that a human embryo is used for industrial or commercial purposes. Thus, claims 1 and 5 of Auxiliary Request 2 are not clear and contravene the requirements of Article 84 EPC.
17. If it is the aim of the introduced disclaimer to restrict the later use of the differentiated pPS cells produced by the claimed method, namely to be used exclusively for the embryo (or the human being derived therefrom) which was used for obtaining the starting material of the claimed method, then the disclaimer is directed to subject-matter which is not covered by the claim. Such disclaimer does not meet the requirements of Article 123(2) EPC is not allowable (cf. T 1836/10 of 9 April 2013, points 11 and 13 of the Reasons).
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This decision has European Case Law Identifier: ECLI:EP:BA:2014:T144113.20140909. The whole decision can be found here. The file wrapper can be found here. Photo "Islets of Langerhans by Sarah Richardson" by University of Exeter obtained via Flickr (no changes made, CC-BY-2.0 license).
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