T 0118/20 11-01-2024

Summary of Facts and Submissions

I. The opponent filed an appeal against the opposition division's interlocutory decision to maintain the European patent No. 2 180 915 as amended according to auxiliary request 3 then on file.

II. Oral proceedings before the Board took place on 11 January 2024.

III. The appellant (opponent) requested that the decision under appeal be set aside and that the patent be revoked.

The respondent (patent proprietor) requested that the appeal be dismissed and that the patent be maintained as found allowable by the opposition division (main request) or on the basis of one of auxiliary requests 5, 6 to 10 and 1 to 4 to be examined in this order, all filed with the letter dated 17 March 2023.

IV. Claim 1 of the main request reads as follows:

"A venous access port assembly (10) for implantation into a patient, the assembly having a housing (12) having a discharge port (16), a needle-penetrable septum (14) and a cap (48) securable to the housing and retaining the septum securely in the assembly, the housing having a housing base (28, 106, 132, 206, 232) defining a bottom wall (44, 104, 130, 204, 230) of at least one reservoir (22), with the housing base having an outwardly facing bottom surface (54, 104, 230), characterized in that:

the housing base (28, 106, 132, 206, 232) includes a set of discrete X-ray discernable alphabetical letters (202) that convey information indicative of an attribute of the assembly (10) on an X-ray when the X-ray of the patient is taken after implantation so that the practitioner can be advised after implantation of the attribute of the assembly;

wherein the X-ray discernible alphabetical letters are embedded within the thickness of the bottom wall (44, 104, 130, 204, 230) of the housing base (28, 106, 132, 206, 232), are centered within a region directly beneath the needle-penetrable septum (14), and are defined in a disc of radiopaque material by cutouts (102) through a body of the disc."

V. Claim 2 of the main request reads as follows.

"The assembly (10) of claim 1, wherein the cutouts (102) are alphabetical letters."

VI. Claim 3 of the main request reads as follows.

"The assembly (10) of claim 1, wherein the disc (100) is affixed to and along the outwardly facing bottom surface (104) of the housing base (106), and the disc (100) is recessed into the bottom surface (104)."

VII. Auxiliary request 5 differs from the main request in that claim 3 has been deleted and claim 4 (i.e. claim 3 of auxiliary request 5) has been amended to read as follows.

"The assembly (10) of claim l or 2, wherein the disc (100) is embedded with the cutouts (102) in a mirror-image orientation when the bottom surface (104) of the housing base (106) is viewed from below."

Claim 5 of auxiliary request 5 reads as follows.

"The assembly (10) of any one of the previous claims, wherein the disc (100) is embedded within the thickness of the bottom wall (130) of the housing base (132)."

VIII. The following documents are referred to in this decision.

D1 US 60/658,518 application for provisional letters

patent

D2 WO 2006/116438 A2

D4 US 6 287 293 B1

D5 Exhibit 1004 - PowerPort Guidelines for CT

Technologists

IX. The appellant's arguments may be summarized as follows.

Main request - claim 1 - added subject-matter

- "discrete alphabetical letters"

Alphabetical letters being voids in a radiopaque disc could not be regarded as forming a discrete set of letters since "discrete" was to be understood as implying "independent from each other" and "unrelated to each other". The letters cut out from a disc were connected to each other by way of the disc and were not arbitrarily separately placeable relative to each other.

Furthermore, only the specific disclosure of the letters "CT" could be derived from Figure 8 of the application as originally filed. Hence, including the feature "discrete" in claim 1 constituted an unallowable intermediate generalisation.

- "letters are defined by cutouts" vs. "cutouts are letters"

The feature "the alphabetical letters are (...) defined in a disc of radiopaque material by cutouts" included an unallowable intermediate generalisation since the original application documents only disclosed letters being cutouts. The wording "defined by cutouts" also encompassed embodiments in which the letters were made of material but defined by cutouts.

- "information indicative of an attribute"

The feature "information indicative of an attribute" was more general than "indicia that visually indicate" in claim 1 as originally filed. The former allowed the attribute to be derived indirectly (for example, the letters might be a model number and the practitioner might then look up the model to determine the attribute); the latter required the indicia to actually indicate the attribute directly (e.g. "CT").

Hence, claim 1 included an unallowable intermediate generalisation.

- "centered within a region directly beneath the needle-penetrable septum"

The feature "the letters are centered within a region directly beneath the needle-penetrable septum" included added subject-matter since the application as originally filed (paragraph [0022]) only disclosed centering the letters within the (entire) region directly beneath the reservoir and the septum so as to minimize any obscuring by the structure of the port assembly.

Contrary to "the region", "a region" could be any region as long as some of it was beneath the septum, and the letters could be placed elsewhere such as on a side wall of the reservoir.

Furthermore, omitting the features "beneath the reservoir" and "such that any obscuring ... is minimized" constituted an unallowable intermediate generalisation.

- combination of "embedded" and "defined by cutouts"

The combination of the features "the letters are embedded within the thickness of the body wall" and "the letters are defined by cutouts through the disc" in claim 1 had no basis in the application as originally filed.

To be embedded within the thickness of the body wall, the letters had to be made of material. At the same time, they had to be formed by cutouts in a disc. However, no such combined embodiment was disclosed in the application as filed.

For these reasons, claim 1 of the main request did not meet the requirements of Article 123(2) EPC.

Main request - claim 2 - added subject-matter

There was a contradiction between claim 1, which implicitly required that the letters were made of material (since they were embedded) and therefore absorbed X-rays, and claim 2, which required that the letters were cut out and did not absorb X-rays. Therefore, the combination of claims 1 and 2 added subject-matter.

Main request - claim 3 - added subject-matter

Claim 3 of the main request, representing the "first embodiment" mentioned in paragraph [0022] of the description, in which the disc was recessed into the bottom surface of the housing base, was incompatible with the feature "the letters are embedded within the thickness of the body wall" in claim 1, which related to the "alternate embodiment" (paragraph [0023]). This incompatible combination was not disclosed, so it added matter.

Claims 18 and 14 as originally filed could not be regarded as a basis for claim 3 as they did not disclose the feature "recessed into the bottom surface".

The application as filed consistently referred to "embedded" and "recessed" as mutually exclusive alternatives (paragraphs [0005], [0012], [0013], [0015], [0016], [0022], [0023] and [0024]).

Claim 1 required the letters to be embedded within, i.e. inside, the thickness of the bottom wall. A partially embedded, i.e. recessed, disc would not be "within" the thickness of the bottom wall as it would have a part outside the thickness of the bottom wall. In the embodiment of Figure 10, the disc was affixed in a recess and then covered by the skirt material, i.e. the disc was not embedded.

Thus, claim 3 of the main request did not meet the requirements of Article 123(2) EPC.

Auxiliary request 5 - sufficiency of disclosure

The term "discrete" meant unrelated and independent, and unrelated and independent letters could not be defined in a disc by cutouts. Hence, the person skilled in the art did not find any teaching in the patent as to how to provide alphabetical letters in a set of discrete X-ray discernible alphabetical letters in which the very same alphabetical letters were defined in a disc of radiopaque material by cutouts through a body of the disc.

The only disclosure of how to embed the disc or letters was by insert moulding (paragraphs [0005] and [0013]), in which the molten material would obviously enter the cutouts shaped as letters. The letters would therefore be made of the bottom wall material. As the voids would be filled with the bottom wall material, it would be impossible for the cut-out letters to be "embedded" (only a physical object, i.e. the disc, could be embedded).

Furthermore, since discrete letters were unclaimed in paragraph [0018] of the amended description filed on 1 October 2019, the person skilled in the art was unable to identify teaching with respect to "discrete" letters for putting the invention into practice, as "discrete letters" could only be identified in connection with disclosure expressly not relating to the invention.

Claim 5 of auxiliary request 5 required both the disc and the letters to be embedded. This was insufficiently disclosed.

Auxiliary request 5 - Article 84 EPC

Claim 1 was not supported by the amended description filed on 1 October 2019 since paragraph [0018] referred to discrete letters as an "unclaimed example".

Auxiliary request 5 - novelty in view of D1

Document D1 disclosed a venous access port with a housing 20, a discharge port 31, a needle-penetrable septum 18 and a cap 14 forming a reservoir 36 (Fig. 1B, paragraph [0038]). It also disclosed in Annex A that the port "may incorporate a metal disc in the bottom of the plastic port", where the disc could have "an alphanumeric message etched on the port disc, that would be visible on radiograph (X-ray)" under the headline "How to determine port type".

The person skilled in the art would inevitably have inferred that the alphanumeric message etched in the disc included the letters "CT" as paragraph [0034] explicitly disclosed the letters "CT", indicating the suitability of the port for power injection during computed tomography. Therefore, D1 disclosed a set of alphabetical letters as required by claim 1.

A disc "incorporated in" the bottom might be a disc at least partially embedded in the bottom. Hence, the metal disc of the port in D1 fell under the subject-matter of the claim.

Since "a" region had to be interpreted to mean any part of the entire region beneath the septum, the alphanumeric message of D1 was inevitably centered within a region beneath the septum.

Etching encompassed embodiments in which material was entirely etched away, resulting in through-holes in a disc, such as cutouts. Hence, D1 disclosed that the message was defined by cutouts through a disc.

Therefore, the subject-matter of claim 1 lacked novelty in view of D1.

Auxiliary request 5 - inventive step starting from D1

The distinguishing features "alphabetical letters", "embedded within the thickness of the bottom wall", "centered within a region directly beneath the septum" and "defined by cutouts through the body of the disc" did not have a synergistic effect. Furthermore, it was obvious from the common general knowledge to include the features "alphabetical letters", "embedded within the thickness of the bottom wall" and "defined by cutouts through the body of the disc" in the access port of D1. In view of D2 (Figure 35) or D4 (Figure 1), it was obvious to include the feature "centered within a region directly beneath the septum" in order to minimize obscuring by the structure of the port.

Thus, the subject-matter of claim 1 lacked an inventive step when starting from D1 and considering the common general knowledge and D2 or D4.

Auxiliary request 5 - inventive step starting from D5

None of the features "embedded within the thickness of the bottom wall", "centered within a region directly beneath the septum" and "defined by cutouts through the body of the disc" could be regarded as a distinguishing feature of claim 1 in view of D5.

Even if they were regarded as distinguishing features, none of them rendered the subject-matter of claim 1 patentable. Providing the alphabetical letters within the thickness of the bottom was an obvious choice for the person skilled in the art. On the basis of D2 or D4, centering the letters within a region directly beneath the septum was obvious for the person skilled in the art. Defining the letters by cutouts through the body of the disc was an obvious alternative since there was no technical advantage of using a disc as a starting point.

Thus, the subject-matter of claim 1 lacked an inventive step when starting from D5.

Auxiliary request 5 - claims 3 and 5 - added subject-matter

The original application documents did not disclose an embedded disc with the cutouts in a mirror-image orientation when viewed from below. Hence, claim 3 of auxiliary request 5 did not meet the requirements of Article 123(2) EPC.

Claim 5 required both the disc and the letters to be embedded. Furthermore, claim 5 was dependent on claim 3, which required the cutouts of the disc to be visible from below. The application as filed did not provide any basis for a combination of such mutually exclusive embodiments.

Adaptation of the description

The access port of Figure 10 did not fall under the scope of the amended claims according to auxiliary request 5. For the sake of clarity, it should therefore expressly be referred to in the description as an "unclaimed example".

Request to amend the minutes

The fourth complete paragraph of sheet 3 of the minutes of the oral proceedings, which reads "With reference to the description, the appellant requested that it should be adapted so that Figure 10 did not represent an embodiment of the patent", should be deleted and replaced with the following: "With reference to the description, the appellant requested that it should be amended so that Figure 10 was explicitly referred to as an unclaimed example".

Furthermore, an additional paragraph should be added, which should read "The respondent (patent proprietor) stated that the amendment was not necessary because Figure 10 was not described as an embodiment".

The minutes were to be corrected since the opponent's submission regarding the adapted description was incorrectly reflected in the current version of the minutes, and the respondent's counter-submissions had been omitted.

X. The respondent's arguments may be summarized as follows.

Main request - claim 1 - added subject-matter

- "discrete alphabetical letters"

The meaning of the term discrete was distinct, individual and separate. Hence, the letters in the disc of Figure 8 of the application as filed were discrete. The feature "discrete alphabetical letters" in connection with the cutout disc was therefore implicitly disclosed in Figures 8 to 12 and paragraph [0022] of the application as filed.

- "letters are defined by cutouts" vs. "cutouts are letters"

A combination of claims 11 and 12 as originally filed could be regarded as a basis for the feature "letters are defined by cutouts". Furthermore, paragraphs [0004], [0005], [0011] and [0014] of the application as originally filed disclosed that the indicia were alphabetical letters.

- "information indicative of an attribute"

The feature "X-ray discernible alphabetical letters that convey information indicative of an attribute of the assembly" could be derived from paragraph [0004] of the description as originally filed without any reference to "visually".

- "centered within a region directly beneath the needle-penetrable septum"

The appellant's interpretation as to the location of the region was technically illogical. In accordance with the literal meaning of the wording and the disclosure of the application as filed, such as Figures 8 to 12, it was clear that this feature required the alphabetical letters to be centered beneath the septum.

Furthermore, as the alphabetical letters were centered in a region beneath the septum and the alphabetical letters were embedded within the bottom wall of the reservoir, it followed that the alphabetical letters would also be centered in a region beneath the reservoir. Hence, omitting the feature "beneath the reservoir" did not constitute an unallowable intermediate generalisation.

- combination of "alphabetical letters embedded" and "defined by cutouts"

The combination of the features "the letters are embedded within the thickness of the body wall" and "the letters are defined by cutouts through the disc" could be derived from claim 11 as originally filed in combination with paragraph [0023].

As the alphabetical letters were defined in the disc, and as the disc was embedded within the thickness of the bottom wall, the letters were embedded within the thickness.

Therefore, claim 1 of the main request did not include added subject-matter.

Main request - claim 2 - added subject-matter

There was no contradiction between claims 1 and 2 since claim 1 did not require the letters to absorb X-rays.

Main request - claim 3 - added subject-matter

There was an explicit basis for the combination of features of a disc being affixed to and embedded within the thickness of the housing base in original claim 18, which referred back to original claim 14.

The phrase "embedding within the thickness" did not require the alphabetical letters or disc to be surrounded on all sides by the bottom wall of the housing. "Embedding within the thickness" also encompassed embedding by being affixed within a recess, as shown in Figure 10 of the application as filed. In this regard, Figure 10 provided a basis for the disc being both embedded within the thickness of the bottom wall and recessed into the bottom surface.

Auxiliary request 5 - sufficiency of disclosure

The meaning of the word "discrete" was distinct, individual and separate, and Figure 8 and the corresponding part of the description in paragraph [0016] of the patent clearly disclosed how a set of discrete X-ray discernible alphabetical letters could be defined in a disc by cutouts through a body of the disc. The skilled person would therefore be able to carry out the invention as defined in claim 1.

Furthermore, Figures 8 to 12 of the patent taught how to provide discrete letters.

Hence, the invention was sufficiently disclosed to be carried out by the person skilled in the art.

Auxiliary request 5 - Article 84 EPC

Claim 1 was supported by paragraph [0007] and Figures 8 to 12 of the patent. The requirements of Article 84 EPC were therefore met.

Auxiliary request 5 - novelty in view of D1

In D1, there was no direct and unambiguous disclosure that there were a plurality of characters, that the characters were alphabetical letters or that the characters were discrete characters.

There was no direct and unambiguous disclosure of the alphanumeric message being embedded within the thickness of the bottom wall of the housing base.

D1 did not disclose where the disc was positioned in the bottom of the port, or where the alphanumeric message on the disc was positioned. As such, there was no direct and unambiguous disclosure in D1 of alphabetical letters being centered within a region directly beneath the needle-penetrable septum.

There was no direct and unambiguous disclosure in D1 that the etched message had to extend all the way through the disc in order to form cutouts through the body of the disc.

Therefore, the subject-matter of claim 1 was novel in view of D1.

Auxiliary request 5 - inventive step starting from D1

There was a synergistic effect between the features "alphabetical letters", "embedded within the thickness of the bottom wall", "centered within a region directly beneath the septum" and "defined by cutouts through the body of the disc" in claim 1 since all these features helped to ensure that the characters on an access port were discernible on an X-ray.

The subject-matter of claim 1 involved an inventive step since it was not obvious for the person skilled in the art to embed the disc within the thickness of the bottom wall, to provide cutouts through the body of the disc and to center the letters beneath the septum.

Auxiliary request 5 - inventive step starting from D5

The features "embedded within the thickness of the bottom wall", "centered within a region directly beneath the septum" and "defined by cutouts through the body of the disc" were not disclosed in D5, and the subject-matter of claim 1 involved an inventive step.

Auxiliary request 5 - claims 3 and 5 - added subject-matter

Paragraph [0023] of the application as originally filed disclosed that, in Figure 12, the disc was embedded within the thickness of the bottom wall and that the X-ray would appear very similar to that shown in Figure 11, i.e. in a mirror-image orientation.

Hence, claims 3 and 5 of auxiliary request 5 did not include added subject-matter.

Adaptation of the description

The access port of Figure 10 was not referred to as an embodiment of the invention in the description. Thus, it was not necessary to amend the description.

Request to amend the minutes

The requested corrections were unnecessary. The opponent's reasons for the corrections were not agreed with.