T 2237/14 - Public prior use by inventor

Key points

• An unusual case of a public prior use by the inventor, based on the priority document expressly stating that a prototype was shown at  meeting with a company. 
• The decision involves alleged public prior use by the inventor. The Board states that
  "For a prior use to be considered established, this has to be the case beyond any reasonable doubt (T 0782/92)."
  
  
  T 2237/14 - link

Reasons for the Decision

1. The appeal is admissible. The filing of the notice of appeal and the payment of the appeal fee between the announcement of the impugned decision at the oral proceedings and its notification by post is not detrimental to the admissibility of the appeal (T 0389/86, OJ EPO 1988, 87).

2. The intervention is admissible.

4. Fresh ground/remittal

As explained above (point II), in the opposition proceedings, the Opposition Division did not admit the late-filed ground for opposition pursuant to Article 100(c) EPC into the proceedings (point 2 of the reasons).

In its notice of intervention, the intervener stated that it wished to adopt the argumentation of the appellant-opponent relating to that objection under the ground for opposition pursuant to Article 100(c) EPC.

This ground for opposition, having not been admitted into the opposition proceedings, hence constitutes a fresh ground for opposition as far as the appeal proceedings are concerned.

According to G1/94, the Enlarged Board of Appeal considered that the intervener has a right to base its intervention/opposition on any ground for opposition of Article 100 EPC. It held that, if a fresh ground for opposition is raised by the intervener, the case should be remitted to the first instance for further prosecution, unless special reasons present themselves for doing otherwise, ...(G1/94, point 13 of the reasons).

This reasoning would in principle have obliged the Board to remit the present case. However, the Board considered that special reasons are present for not doing so.

As mentioned above, the Opposition Division made a prima facie analysis of the objection. According to the Board, it would therefore appear to be a rather formal approach to remit the case back to the Opposition Division, only for it to most probably confirm the opinion already expressed in the decision on the basis of that prima facie analysis.

Additionally, in the present proceedings (concerning a patent having a filing date of 27 February 1997), the appellant-opponent, the intervener and the Judge at the court in Düsseldorf in charge of infringement proceedings in Germany based on the patent in suit have all requested acceleration of the proceedings.

Finally, the subject-matter concerned is not so complex that the parties and the Board cannot understand the objections, and the respondent-patent proprietor has not requested remittal.

For all these reasons, the Board decides to examine this objection in the appeal proceedings and not to remit the case to the department of first instance.

5. Added subject-matter (Article 100(c) EPC)

The intervener and the appellant-opponent considered that the subject-matter of claim 1 was an unallowable intermediate generalisation. Claim 1 did not include all the essential features of the embodiments of Figures 103 to 105. The general part of the description, in particular paragraphs [0031] and [0036] (of the published version of the application), could not be used as a basis for the subject-matter claimed because not only did the two paragraphs refer to different, separate embodiments, but paragraph [0036], by referring to the inward movement of the needle trap and arm for the releasing of the catheter hub, unequivocally implied the presence of an inner recess in the catheter hub.

The Board does not share this opinion, for the following reasons.

The general part of the description has to be considered. In the application as filed, the problems met in prior art devices are summarised as follows (paragraph [0016] of the application as published): "The basic problem with many of the present day safety hypodermic devices is that they are meant to be manually activated, or in the language of the medical device industry, they are considered "active" devices. They may have safety shields, retractable needles, moveable sheaths or the like; but they generally require the user to complete another procedure to facilitate engagement of the safety mechanism.(...)"

[...]

Therefore, when read with the application as a whole in mind, paragraphs [0031] and [0036] are an unambiguous general basis for claim 1, so that Article 100(c) EPC does not prejudice the maintenance of the patent as granted.

In view of the above, since paragraphs [0031] and [0036] form a sufficient basis for claim 1, other objections pursuant to Article 100(c) EPC raised in the written proceedings and based on specific features of the specific embodiments allegedly not taken over into claim 1 are not relevant. It is noted that they were not pursued at the oral proceedings either.

6. Admissibility of the alleged prior uses

At the oral proceedings, the appellant-opponent and the intervener wanted objections of lack of novelty of the subject-matter of claim 1 over three prior uses to be examined. Hence, it was first necessary to assess whether these prior uses were in the proceedings or were to be admitted into the proceedings.

6.1 Admissibility of the alleged "Guardian Design" prior use

Since the intervention took place in the appeal-opposition proceedings, pursuant to G3/04 (point 10 of the reasons) the intervener has the same status as a non-appealing party pursuant to Article 107 EPC. Therefore the RPBA also apply to the intervener.

The alleged "Guardian Design" prior use had been considered late-filed by the Opposition Division and disregarded. It was re-introduced by the intervener in its notice of intervention (Facts and Submissions, point IV). As can be seen, the intervener referred to this alleged prior use by simply citing the former documents (filed by the appellant-opponent in the opposition proceedings) and making a general reference to the earlier respective submissions of the same appellant-opponent, in other words, the submissions filed during the opposition proceedings. No further substantiation was provided in the notice of intervention. According to the established case law of the boards of appeal, such general references to other submissions are not considered to be a proper substantiation of the objection raised, because it cannot be left to the Board or the other party/parties to find out what the line of argument of the intervener actually was. This is particularly true for alleged prior uses for which the relationships between the different pieces of evidence have to be assessed.

Hence, any substantiation presented by the intervener later on in the proceedings has to be considered late-filed and a change of its case.

After filing its notice of intervention and prior to the oral proceedings, the intervener did not file any further written substantiation of this prior use. It was only at the oral proceedings that the intervener wished to discuss it or, in other words, to complete its substantiation.

Alleged prior uses are a complex matter to examine, as features of the object that has allegedly been shown have to be determined, and their availability to the public scrutinized. Such examination cannot be started at oral proceedings, when neither the other parties nor the Board have prepared for it, because up to that point, they had no reason in the file to do so. This is a typical situation dealt with under Article 13(3) RPBA, because neither the other parties nor the Board can reasonably be expected to deal with such an amendment of the intervener's case without the oral proceedings being adjourned.

The Board therefore decides not to admit the alleged "Guardian Design" prior use into the proceedings pursuant to Article 13(3) RPBA.

6.2 Admissibility of the other two prior uses

With letter of 11 September 2015 the appellant-opponent filed evidence for two further prior uses. He submitted that he had conducted "discovery proceedings according to 28 U.S.C. § 1782 in the United States" against InjectiMed Inc. and its president Mr. Thomas C. Kuracina, co-inventor of the patent in suit.

According to the findings, two public prior uses had taken place, one on 18 November 1996 and one on 27 November 1996:

1) the submission of engineering drawings according to Figure 35 of priority document P3 [ US 60/031399: third priority document of the patent in suit filed 19 November 1996] to Sherwood-Davis & Geck as an attachment to a letter dated 27 November 1996 (exhibit 12.5),

2) the demonstration of eight working prototype versions of the indwelling catheter according to Figures 19 and 35 of P3 to two employees of Johnson and Johnson Medical, Inc. on 18 November 1996.

According to the appellant-opponent the subpoena was sent to Mr Kuracina on 22 May 2015, and the final decision of the US court on which of the documents must be considered confidential and which not was taken on 4 September 2015. The documents were filed with the EPO on 11 September 2015, so that, according to the appellant-opponent there was no lateness. In addition, the disclosed devices were according to Figure 103 of the patent in suit, so that they were more relevant than the documents on file.

6.2.1 Sherwood-Davis & Geck

According to the appellant-opponent, engineering drawings representing the embodiment of Figure 35 of P3 [ US 60/031399: third priority document of the patent in suit filed 19 November 1996 ]were attached to a letter (exhibit 12.5) written by Mr Gordon (of InjectiMed Inc.) and sent to Mr Vacca (of Sherwood-Davis & Geck) on 27 November 1996.

In the Board's opinion, while at the end of the first page of the letter, it is mentioned that "our new design will not allow separation of the catheter hub from the needle guard until the needle point is completely trapped and safe from needle stick injury", and engineering drawings and artist's renditions are mentioned (at the end of the second page of the letter) as being enclosed, no specific features of the new design are described in the letter, and the drawings or artist's renditions mentioned were not filed by the appellant-opponent. It follows that on the basis of this evidence it is, prima facie, not possible to know what the constructive features of the product mentioned in the letter were. In addition, Mr Kuracina stated (pages 133 and 134 of his deposition (exhibit 12.1)) that he was not aware of the existence of engineering drawings.

In view of the absence of any plausible evidence as to the features of the device mentioned, the Board decides not to admit the prior use into the proceedings pursuant to Article 13(1) RPBA.

6.2.2 Johnson and Johnson Medical, Inc.

This prior use concerns the alleged disclosure of prototypes of the IV catheters according to Figures 19 and 35 of P3. In P3 [ the third priority document of the patent in suit filed 19 November 1996.] at the top of page 49, it is mentioned that prototype versions of an IV catheter according to Figures 19 and 35 were manufactured on 10 October 1996 with a through hole instead of an annular recess for retaining the projection of the arm in the hub. On the same page 49, it is stated in the last but one paragraph that "Eight welded working prototype samples were demonstrated and disclosed to Johnson & Johnson Medical, Inc. on 18 November 1996 by John R.Gordon of InjectiMed.Inc. Wiley Green and Brian Blischak, both of Johnson & Johnson Medical Inc., were present at the meeting."

Furthermore, in exhibit 12.11, presented as being a report on the meeting of 18 November 1996, the manufacturing of an annular ring in the catheter hub appears to have been discussed.

Hence, prima facie, if confirmed, this alleged prior use IV catheter assembly might have all the features of claim 1.

The respondent-patent proprietor considered that this alleged prior use should not be admitted into the proceedings because the information on the prototypes and demonstrations was in the priority document, and was thus present right from the start of the opposition proceedings, so the appellant-opponent could have invoked it earlier. The appellant-opponent did not even mention its intention in the statement setting out the grounds of appeal filed on 15 April 2015, and did not actually start the discovery proceedings in the US until 28 April 2015.

In the Board's opinion, while it is true that the demonstration of the prototypes by Mr Gordon is mentioned in priority document P3, which was in the file right from the beginning of the opposition proceedings, in the present case it considers that the relevance of the prior use, which would be the most relevant piece of prior art if proven to have been shown, outweighs the lateness of its filing. Apart from the fact that the appellant-opponent might genuinely have thought that the patent would be revoked in the first instance on the basis of the patent documents on file in the opposition proceedings, the prior use was not a prior use by itself, but by the respondent-patent proprietor, so was in any case more difficult to establish. The proceedings in the USA appear to have been conducted swiftly, and the appellant-opponent filed the result of these proceedings with the EPO as soon as it could after having received them. Moreover, as mentioned, the alleged prior use concerned is by the respondent-patent proprietor itself, so that it cannot a priori pretend to have particular difficulties establishing the circumstances under which it occurred.

For the above reasons, the Board decides to introduce the alleged prior use at Johnson and Johnson Medical, Inc. into the proceedings pursuant to Article 13(1) RPBA.

7. Novelty

7.1 In view of the prior use at Johnson and Johnson Medical, Inc.

As already mentioned, this alleged prior use is essentially based on page 49 of priority document P3, the deposition of Mr Kuracina (exhibit 12.1), the report on the meeting of 18 November 1996 (exhibit 12.11) and the presentation given on 27 March 1997 to Johnson and Johnson Medical, Inc. (exhibit 12.12).

Before assessing the alleged availability to the public, the Board wishes to concentrate on the features allegedly disclosed.

On page 49 of P3, the first full paragraph reads as follows: "Working prototype versions of the indwelling catheter invention disclosed and described in this application in Figures 19 and 35 were manufactured by Thomas C. Kuracina on 10/10/96 by assembling a number of molded components, using a flexible tether."

In the middle of the second paragraph it is stated that: "...The catheter hub 13' was releasably held adjacent to the catheter adapter 78 by means of a through hole (rather than the annular recess 32 shown through out this application) in the catheter hub 13' wall section ..."

Finally, the third full paragraph of the same page reads as follows:

"Eight welded working prototype samples were demonstrated and disclosed to Johnson & Johnson Medical, Inc. on 18 November 1996 by John R.Gordon of InjectiMed, Inc. Wiley Green and Brian Blischak, both of Johnson & Johnson Medical Inc. were present at the meeting."

Exhibit 12.11 is a one-page report on the meeting of 18 November 1996 written by Mr John Gordon. The relevant passage is headed "NOTE" and reads as follows: "The one area of conjecture revolved around our implied ability to mold-in an annular ring in the Catheter Hub, without going to a split mold. I assured them that while I knew little of nothing about molding, that C&R was confident of their ability to mold-in the ring in a straight-pull molding operation. This has been re-affirmed by Craig and Randy."

In the final paragraph of this report it is stated that samples of a molded-in annular ring in a Luer hub should be available at the next meeting.

In his deposition, Mr Kuracina indicated several times that he had manufactured multiple prototypes, and so could not be sure of the precise constructive features each of them had (for instance, page 50, line 25 to page 51, line 3: "I manufactured multiple prototypes of multiple platform needles and this is just one of those prototypes." or page 83, lines 17 to 19: "There were so many products and I don't know exactly which ones, what versions were submitted.", pages 147 - 151, etc.), and that at the time of his declaration no prototype of the IV catheter from 1996 existed anymore (page 162).

The slide of the presentation of 26 March 1997 (exhibit 12.12) on page TK0000151 shows an IV catheter with a needle guard and a releasing mechanism for releasing the catheter hub whereby the projection on the arm (attached to the needle trap) is retained behind an undercut (not a recess). This undercut is also designated "undercut" on the drawing.

According to the appellant-opponent and the intervener, the statements on page 49 of P3 were sufficient to determine the features of the IV catheter manufactured as a prototype and shown to Johnson and Johnson Medical, Inc. The report on the meeting held on 18 November 1996 showed that the option of having a recess in the hub was discussed at that very meeting, which would in itself be a disclosure anticipating the subject-matter of claim 1.

The Board does not share this opinion. For a prior use to be considered established, this has to be the case beyond any reasonable doubt (T 0782/92). In the present case, the Board firstly notes that the relevant meeting was held in November 1996, almost 20 years before the oral proceedings before the Board, and that there is no deposition on file by any of the persons having directly participated in that meeting. Secondly, prototypes are generally made to assess the workability of some technical concept, so that they do not necessarily reproduce all the features of the intended finished product. This is confirmed by Mr Kuracina on page 52, lines 5 to 8, of his deposition when he was asked if the said figure referred to on page 49 of P3 was Figure 19: "Clearly this does not indicate that every feature of in the drawings were included in the prototype and that's what I have to say about that." 

What exactly the prototypes were made for is not mentioned in the first paragraph of page 49 of P3, where, as already stated, it is only mentioned that (several) working prototype versions of the indwelling catheter invention disclosed in this application in Figures 19 and 35 were manufactured. What is mentioned is that the tether was flexible, and, according to the middle sentence of the second paragraph, that there was no annular recess, but a through-hole instead. Hence, apart possibly from other constructive features, at least the annular recess appears not to have been present in the prototype versions.

The appellant-opponent considered that this was in any case disclosed by the report on the meeting (exhibit 12.11).

The Board does not share this view, since the relevant paragraph of the report was about conjecture around the ability to mold-in an annular ring without going to a split mold. Whether or not the annular ring referred to in that report was the annular recess shown on Figure 19 is also not apparent from the report. Moreover, P3 mentions several times that the retaining element in the catheter hub could be an inner channel, recess, slot or undercut (page 31, page 33, page 40, page 42, etc.). It follows that when the report mentions an annular ring, it is not clear whether it means one of these elements, and if so, which one, or whether it means something else entirely. On top of that, the report (exhibit 12.11) makes no reference at all to either Figure 19 or Figure 35 of P3, so that there is no direct link to these embodiments apparent from that report. Additionally, and independently of the report, the undercut in the catheter hub of the IV catheter shown in a presentation at Johnson and Johnson Medical, Inc. sometime later (the drawing presented on page TK0000151 of exhibit 12.12), while clearly not a recess, can technically be designated an annular ring, which casts additional doubt on the likelihood of a recess being discussed at the meeting on 18 November.

It follows that it is not possible to determine without any reasonable doubt, what was disclosed at the meeting Mr Gordon had at Johnson and Johnson Medical, Inc.

For the above reasons alone, the prior use of an IV catheter according to Figure 19 or Figure 35 is not established, so that it is not established that an IV catheter according to claim 1 was shown at the meeting with Johnson and Johnson Medical, Inc. For these reasons, it is also not necessary to examine whether or not the disclosure was confidential, the subject-matter of claim 1 being in any case novel over the alleged prior use.

7.2 The intervener and the appellant-opponent considered that the subject-matter of claim 1 lacked novelty over D3, D2 and D1.

7.2.1 Before going into the details of the novelty analysis, the Board would like to clarify the following:

[...]

8. Inventive step

Although the validity of the priority was disputed among the parties, the Board decided to consider the lack of inventive step objections based on D1 and D2 (intermediate documents under Article 54(3) EPC in case of validity of the priority). None of the parties objected to this.

8.1 The appellant-opponent and the intervener raised the following lines of argument in relation to the objection of lack of inventive step:

D2 or D3 alone; D2 in combination with D3 or D1; D3 in combination with D2 or D16; all latter lines of argument possibly in combination with D4, if the tether was considered a differentiating feature.

8.2 Admissibility of the line of argument based on D16

The intervener considered that it was sufficient for the admissibility of a line of argument based on D16 for this document to be mentioned in the notice of intervention.

The Board does not share this opinion. In the notice of intervention (Facts and Submissions, point IV), the only sentence which includes a reference to D16 is the following: "Appellant-opponent II relies on all documents D1 - D18 filed with the notice of opposition of Appellant-opponent I." This is by no means a substantiated line of argument based on a combination of D3 with D16 meant to be presented at the oral proceedings. As already mentioned above in relation to the Guardian Design prior use, oral proceedings are not the time to present new lines of argument or objections not submitted in the written proceedings. The examination of such new lines cannot be started at oral proceedings, when neither the other parties nor the Board are prepared, because up to this point, D16 has played no role in the appeal proceedings. This is a typical situation dealt with under Article 13(3) RPBA, because neither the other parties nor the Board can reasonably be expected to deal with such an amendment of the intervener's case without the oral proceedings being adjourned.

The Board therefore decided not to admit the line of argument based on D16 into the proceedings pursuant to Article 13(3) RPBA.

8.3 Starting from D2

[...]

8.5 For the reasons given above, the subject-matter of claim 1 is inventive, so that the ground for opposition pursuant to Article 100(a) EPC in combination with Article 56 EPC does not prejudice the maintenance of the patent as granted.

As already indicated, documents D1 and D2 could be prior art pursuant to Article 54(3) or 54(2) EPC depending on the validity or not of the priority P3 of the patent in suit. Since, however, as demonstrated above, the subject-matter of claim 1 was inventive even if D1 and D2 were documents pursuant to Article 54(2) EPC, the validity of the priority P3 did not have to be examined by the Board.

Order

For these reasons it is decided that:

1. The appeal is dismissed.

2. The intervention is rejected.