Tuesday, 14 February 2012

T 1285/11 – Something Special

The applicant filed an appeal after the Examining Division (ED) had refused his Euro-PCT application.

The application as originally filed contained 28 claims. The product claims 1 to 22 and 26 to 28 were directed to various solid-state forms of (3-(((4-tert-butyl-benzyl)-(pyridine-3-sulfonyl)-amino)-methyl) -phenoxy)-acetic acid sodium salt or a hydrate thereof.

The EPO, acting as an ISA, considered the application to be non-unitary and the claims to cover nine inventions: (1) claims 1 (in part), 20 and 21 ; (2) claims 1 (in part), 2-4, 17-19, and 22-25) ; (3) claims 1 (in part) and 5-7 ; (4) claims 1 (in part) and 8-10 ; (5) claims 1 (in part), 11 and 12 ; (6) claims 1 (in part), 13 and 14 ; (7) claims: 1 (in part), 15 and 16 ; (8) claims 26 and 27 ; (9) claim 28.

The reasons given for the finding of non-unity were essentially that document D1 already disclosed (3-(((4-tert-butyl-benzyl)-(pyridine-3-sulfonyl)-amino)-methyl) -phenoxy)-acetic acid sodium salt as a white solid for use in treating conditions that are related to the modulation of prostaglandin. Because it already belonged to the prior art, said salt could not be viewed as constituting a “special technical feature” in the sense of Rule 13.2 PCT. The problem of providing further forms of said salt had been solved by providing different polymorphs thereof according the nine inventions listed. These inventions were therefore not so linked as to form a single general inventive concept, contrary to the requirements of Rule 13.1 PCT.

Since no additional search fees were paid, the ISR was restricted to the invention first mentioned in the claims.

Together with the request for entry into the European phase, the applicant filed amended claims 1 to 10 relating to invention (2) above.

In a first communication dated 21 September 2010, the ED referred to the written opinion of the ISA, and noted that no additional fees had been paid in the international phase, following an objection of lack of unity by the ISA. It was therefore requested that the applicant “restrict the claims to invention 1 as required by R 164(2)”.

The applicant disputed that R 164(2) could be seen as a bar to further prosecution based on the subject-matter now claimed, since a search with respect to the subject-matter as defined under “invention 1” would inevitably also have covered crystalline form A of the present salt. No further search was therefore required.

The ED maintained its objection. It finally refused the application at the end of oral proceedings (OPs) held on 7 March 2011.

According to the written decision, the ED considered that the subject-matter of this request contravened R 164(2) and R 137(5). It considered that the fact that no further search fees or protest fees had been paid in the international phase amounted to a tacit agreement on the part of the applicant with the findings of non-unity of the ISA. With reference to decision G 2/92 and the Guidelines for Examination, chapter III, point 7.11.4, the ED submitted that the only way for the applicant to seek protection for the present subject-matter would be to file a divisional application.

Here is what the Board of appeal had to say:

Refusal based on R 137(5)

[2] The ED inter alia relied on R 137(5) in refusing the present main request, citing the text of this R according to which “amended claims may not relate to unsearched subject-matter which does not combine with the originally claimed invention or group of inventions to form a single general inventive concept”.

The board notes that this wording is the same as that of R 86(4) EPC 1973. This rule was introduced to give the EPO the means to react appropriately when the applicant dropped existing claims and replaced them with originally non-unitary subject-matter extracted from the description (see the Notice published in OJ EPO 1995, 409, in particular pages 420 and 421, point 2; see also Guidelines for Examination, C-VI, 5.2(ii), in particular the second paragraph of this section). This is also reflected in the passage of the Guidelines for Examination cited by the ED in this context, namely, chapter III, point 7.11.1(iv), which states that, 
“if the claims to be examined relate to an invention which differs from any of the originally claimed inventions and which does not combine with these inventions to form a single inventive concept, an objection under R 137(5) should be raised in the first communication” (emphasis added).
Indeed, according to well-established case law, 
“R 86(4) does not apply when the applicant has not paid the search fee in respect of a non-unitary invention relating to the originally filed claims” (see T 708/00, [7, 5-8]).

In the present case, the subject-matter of the amended claims according to the main request was already present in the claims as originally filed (see claims 2 to 4, 17 to 19, 22 to 25). Therefore, the main request does not contravene R 137(5) and may not be refused on this basis.

Refusal based on R 164(2)

[3.1] R 164(2), which entered into force with the 2000 on 13 December 2007, applies to the present application, since the international application on which it is based […] was filed on 25 August 2008. This rule requires that,
“where the ED finds that the application documents on which the European grant procedure is to be based do not meet the requirements of unity of invention, or protection is sought for an invention not covered by the ISR ..., it shall invite the applicant to limit the application to one invention covered by the ISR ...” (emphasis added).
The board notes that it can already be deduced from the juxtaposition of the expressions “an invention not covered by the ISR” and “one invention covered by the ISR” that, in order for R 164(2) to be applicable, the respective non-searched and searched inventions being referred to cannot belong to a single invention and must indeed be non-unitary with respect to one another. As aptly analysed in the decision of the Legal Board of Appeal J 3/09 [3.5.7], it is also implied by the wording of R 164(2), giving the EPO the power to invite the applicant to limit the application to one invention covered by the ISR, that where there is in fact only “one” invention there is no sanction.

According to the practice of the EPO, as set out in the Guidelines for Examination (C-III, 7.10, first paragraph) and explained in detail in decision J 3/09 [3.5.6]), the responsibility for establishing whether or not the application meets the requirements of unity of invention ultimately rests with the ED, and the opinion of the EPO acting as the ISA on lack of unity is not final or binding on the ED. The fact that the applicant did not pay further search fees or protest fees in the international phase cannot therefore be seen as a tacit agreement with the findings of non-unity of the ISA, as submitted by the ED in the decision under appeal.

The situation referred to by the ED, whereby subject-matter in respect of which a search fee has not been paid can only be pursued in a divisional application, presupposes that the searched and non-searched inventions are in fact found to be non-unitary when the ED upon review agrees with the opinion of the search division (see decision J 3/09 [5.1-7] and references therein to decisions G 2/92 and T 631/97; see also Guidelines for Examination, C-III, 7.10, third and fourth paragraphs, and 7.11.1(ii),(iii)).

To the extent that an objection of non-unity raised by the ISA turns out to be unjustified, the applicant is entitled as of right to have the whole subject-matter of his unitary invention searched. If need be, an additional search would have to be performed (see Guidelines for Examination, C-III, 7.10, third paragraph, last sentence, and 7.11.1(v); decision J 3/09 [3.5.6, 5.2]), regardless of whether or not this might involve an additional effort.

With respect to the ED’s reference to the Guidelines for Examination, chapter III, point 7.11.4 […], it is noted, for the sake of completeness, that this relates to the situation where the EPO has established an international preliminary examination report (IPER). An IPER has not been issued in the present case, since the applicant did not file a demand requesting examination of the international application by the IPEA (Chapter II of the PCT). In addition, it is noted that point 7.11.4 must be read in the context of preceding point 7.11.3, which explicitly refers to the case where “the applicant successfully refutes the objection ... or the interpretation of the rules regarding unity of invention was erroneous”.

[3.2] Consequently, in order to establish whether R 164(2) is applicable in the present case, it must be decided whether the ED was correct in its assessment that the subject-matter now claimed in the main request (“invention 2”) and the searched subject-matter (“invention 1”) are non-unitary.

The objection of lack of unity of the ISA, on which the examination division relied, was raised a posteriori, based on document D1 […]. In Step D of Example 14d (page 200), a process is disclosed for the synthesis of the present sodium salt, which is obtained as a “white solid”. Thus, this material already forms part of the prior art, but its solid-state structure is not specified, that is, whether it is crystalline, non-crystalline or amorphous (cf. application in suit, originally filed claims 1 to 25; 26, 27; and 28, respectively). It must therefore be concluded, prima facie, that any one of these features, including “crystallinity”, defines a contribution over the prior art, and therefore qualifies as a potential “special technical feature” in the sense of R 44(1).

The ED argued in this context that, although the ISA had found “invention 1” to be novel with respect to document D1, it had not considered it to be inventive with regard to said document (cf. above point XI). However, it is noted that this opinion of the ISA on novelty and inventive step was not included as part of the analysis relating to unity, and for good reason. Indeed, in the present case, a definitive conclusion as to whether the common concept of “crystallinity” is novel and inventive cannot be reached without a full substantive examination procedure, with active participation of the appellant. This is clearly required in order to establish what solid-state form is actually obtained in Example 14d of document D1 […], and whether any claimed subject-matter possesses surprising properties with respect to the prior art material, as contended by the appellant […].

Consequently, the board concludes that, prima facie, the feature of “crystallinity” can be regarded as constituting a “special technical feature” in the sense of R 44(1), establishing unity between present “invention 1” and “invention 2” in accordance with A 82. Accordingly, as explained above under point 3.1, R 164(2) cannot be seen as a bar to further prosecution based on the subject-matter now claimed in the main request.

Remittal to the first instance

[4] It follows from the preceding considerations that the reasons for the refusal of the present application by the ED were not justified. Under these circumstances, the board exercises its power under A 111(1) and remits the case to the ED for further prosecution.

Examination can thus be resumed on the basis of the main request.

The ED will have to consider whether an additional search is required in the present case […].

With respect to the issue of clarity, it will in particular have to be examined whether the main request meets the requirements of A 84, taken in combination with R 43(2), in respect of the number of independent claims in the same category.

In addressing the issue of novelty, the ED should assess whether convincing evidence or arguments have been provided to establish that the claimed crystal form is in fact novel over the product produced by the process according to Example 14d of document D1.

Reimbursement of the appeal fee

[5] According to A 113(1), the decisions of the EPO may only be based on grounds on which the parties concerned have had an opportunity to present their comments. In this context, the word “grounds” should be interpreted as referring to the essential reasoning, both legal and factual, which leads to the refusal of the application (see T 951/92 [3(v)]).

In the present case, the ED referred in a first communication to the written opinion of the ISA stating that the claims as originally filed were non-unitary, and, with reference to R 164(2), requested that the applicant restrict the claims to the invention for which a search fee had been paid […]. This is in accordance with standard procedure as outlined in the Guidelines, chapter C-III, 7.10.

However, in response to the counter-arguments submitted by the applicant, the ED merely referred once again to R 164(2) […]. This pattern was repeated in the subsequent reply of the applicant and summons to attend OPs, despite the fact that the applicant had submitted additional arguments and requested a reasoned response from the ED […]. Finally, in its letter of 4 February 2011, the applicant provided a yet more detailed analysis of the case and once again complained of the lack of reasoned response on the part of the ED […]. This letter remained unanswered prior to OPs held before the ED on 7 March 2011.

Thus, neither of the communications of the ED referred to in the previous paragraph was in line with the requirements of R 71(2), since they contained no reasoned statement as to why the arguments of the applicant had not been accepted and the objection under R 164(2) maintained. This conduct of the ED thus deprived the applicant of the possibility of preparing meaningfully for the scheduled OPs since it was not clearly informed of the essential reasons on which the findings of non-compliance were based.

Regarding the decisive question of whether “inventions 1 and 2” were to be considered unitary […], the ED submitted that, since it had invoked and applied R 164(2) in its communications, it was implicit that it had reviewed the non-unity objection brought forward in the international phase and found this to be justified […]. However, in order to satisfy A 113(1), the outcome of this review should have been communicated in such a way as to permit the applicant to understand and respond to the essential reasons for the conclusion reached.

Indeed, from the statement of grounds of appeal […], it is apparent that the reasoning of the ED for rejecting the applicant’s argument that “crystallinity” was to be seen as a “special technical feature” was only communicated to the applicant with the decision under appeal.

Moreover, it is apparent, from the communications of the ED and from the minutes of the OPs before the ED, that the objection under R 137(5), on which the refusal was also based, was communicated to the applicant for the first time in the form of a statement at the conclusion of OPs.

In view of the above, it must be concluded that the refusal of the application was based on legal and factual reasons which were presented for the first time in the decision under appeal and on which the appellant was therefore given no opportunity to present its comments. The board considers that this failure to comply with the requirements of A 113(1) constitutes a substantial procedural violation and that it is therefore equitable to order the appeal fee to be reimbursed in accordance with R 103(1)(a).

Should you wish to download the whole decision, just click here.

The file wrapper can be found here.

A French summary is available here.


Myshkin said...

What took the place of the European search report was made up BEFORE April 1, 2010, so Rule 137(5) EPC does not even apply to this application according to the transitional provisions. (Old) Rule 137(4) EPC did apply.