T 823/11 Excessive length of proceedings
The Board of Appeal considered the examination proceedings excessively long (11 years between supplementary search report and oral proceedings). This was seen as a substantial procedural violation. The same holds for the lack of reasoning in the communications and decision of the examining division. The Board sets out the case law on both issues.
The Board does not remit the case but takes over and orders the auxiliary request (which was not admitted by the examining division) to be granted.
Summary of
Facts and Submissions
I. The
appeal lies from the decision of the Examining Division posted on 30 September
2010 to refuse European patent application No. 96915827.8, which was filed as
international application PCT/US96/06944 published as WO 96/36923.
The
decision was issued against "Cardinal Health 303, Inc.". A change of
the applicant's name to "CareFusion 303, Inc." was registered by the
EPO with effect on 4 November 2010. The appeal was filed on 30 November 2010 by
the applicant under its new name.
II. The
present application, which concerns the configuration of a clinical device in a
patient care management system, was filed on 15 May 1996 and entered the
European phase on 15 December 1997. The supplementary European search report
was completed on 18 February 1999.
During the
proceedings the applicant sent two reminders, with letters dated 22 March 2004
and 4 September 2006, pointing out that a long time had passed since the last
action by the EPO and enquiring about the further prosecution of the case.
The first
communication of 7 June 2004 referred to documents D1 (US-A-4 847 764,
published on 11 July 1989) and D2 (US-A-5 401 059, published on 28 March 1995)
and raised objections under Rule 29(2) and Articles 52(1) and 56 EPC 1973. The
claimed invention was considered to lack inventive step over the disclosure of
document D1 in column 2, line 65 to column 6, line 2 and Figure 1. Later two
further communications were sent out by the Examining Division on 18 March 2005
and 13 November 2006. The applicant replied to all these communications,
amending the claims once, and each time presenting its counter-arguments. The
last reply letter was dated 10 August 2007.
The
applicant was summoned to oral proceedings with a communication of 8 March
2010, which contained the preliminary opinion of the Examining Division. It
reacted to this communication with the submission of a main request and an
auxiliary request. After a telephone conversation with the first examiner on 11
June 2010, in which clarity deficiencies were discussed, the applicant replaced
both requests with a single main request. At the oral proceedings before the
Examining Division, the appellant submitted an auxiliary request.
III. The
application was refused for lack of inventive step, Articles 52(1) and 56 EPC,
of the subject-matter of the independent claim of the main request. The
Examining Division invoked the common general knowledge and the prior art
disclosed by document D1.
The
Examining Division did not admit the auxiliary request submitted at the oral
proceedings. In its decision, the Division also mentioned that the dependent
claims of the main request appeared to lack inventive step. In an obiter dictum
it expressed the opinion that the claimed system was not clearly defined.
IV. The
reasons given in the decision under appeal can be summarised as follows:
Under
"SUMMARY OF FACTS AND SUBMISSIONS" the Examining Division explained
that the late-filed auxiliary request, submitted during the oral proceedings,
was not admitted into the procedure because it did not prima facie overcome the
previously raised objection of lack of inventive step.
Regarding
the reason for refusal of the main request, the Examining Division argued that,
insofar as the claims could be understood, it appeared that the technical
contribution of the present application was the avoidance of errors when
programming a clinical device, obtained via an automatic inputting of data and
checks. It then stated:
"Now,
the entering of data in a digital system not manually in order to avoid human
errors is, in effect, the obvious known way to solve the posed problem since
the introduction of the coded data reading devices, in particular bar code
reader, derived from the common knowledge, while the checks ( comparisons
between stored and entered data ) which are also obvious measures for a skilled
person are furthermore suggested in the prior art.
For example
Dl: US-A-4 847 764 (HALVORSON JERRY L) 11 July 1989 (1989-07-11), discloses a
system for dispensing drugs in health care institutions, see in particular
lines 48 - 55 of col. 4 of this document."
In an
obiter dictum the Examining Division said that the presence of the two
processors did not appear to play any role in the working of the claimed system
and that the "unessential presence" of those features in the claim
introduced ambiguity. The results of the comparisons were independent of the
location where they took place.
V. In the
statement of grounds of appeal, the appellant requested that the decision be
set aside and a patent be granted on the basis of the claims of the main
request or, alternatively, of the auxiliary request (titled "Subsidiary
Request"), both requests filed with the grounds of appeal and
corresponding exactly to the requests on file at the time of the decision.
VI. The
appellant was invited to oral proceedings before the Board. In a subsequent
communication sent in advance of the oral proceedings, the Board expressed the
preliminary view that none of the appellant's requests was allowable.
The Board
cited two further documents, D3 and D4: […]
The Board
considered in particular that the subject-matter of claim 1 of the main request
did not appear to be inventive in view of document D1 and the common general
knowledge. The Board raised concerns with respect to the inventive step of the
subject-matter of the auxiliary request over the disclosure of documents D1 and
D3. The Board furthermore discussed issues related to clarity and added
subject-matter and explained why also document D4 appeared to be relevant for
the question of inventive step.
VII. With a
letter of reply, the appellant withdrew its request for oral proceedings and
requested that a decision be taken based on the file as it stood.
VIII. Oral proceedings
were held on 6 October 2015 in the absence of the appellant. At the end of the
oral proceedings, the chairman announced that the Board's decision would be
given in writing.
IX. The
appellant's final request was that the contested decision be set aside and that
a patent be granted on the basis of the claims of the main request or,
alternatively, of the auxiliary request, both requests resubmitted with the
statement of grounds of appeal.
X. Claim 1
of the main request reads as follows:
"A
patient care management system comprising:
a first
programmable computer (80) for processing and storing patient and clinical
device configuration data;
a second
programmable computer (45) for verifying, monitoring and recording medical
treatment provided to the patient;
first input
means, comprising a bar code reader (90) operatively connected to the first
programmable computer (80) for input of data comprising patient data to the
first programmable computer;
second
input means operatively connected to the second programmable computer (45) for
input of data comprising patient data and clinical device configuration data to
the second programmable computer (45); the second programmable computer (45)
storing said data comprising patient data and clinical device configuration
data input by the second input means;
a clinical
device (92) operatively connected to the first programmable computer (80) for
delivering medication to the patient;
communication
means (50) for operatively connecting the first programmable computer (80) to
the second programmable computer (45), wherein the data comprising patient data
input into the first input means (90)
is
communicated to the second programmable computer (45) by the communication
means; and
wherein the
second programmable computer (45):
verifies
the data comprising patient data input into the first input means (90) with the
stored patient data; and
when the
verification is complete, automatically communicates clinical device
configuration data to the first programmable computer (80) to configure the
clinical device (92)."
XI. Claim 1
of the auxiliary request differs from claim 1 of the main request in that:
(i) in the
first listed feature, the text "storing patient and clinical device
configuration data" has been replaced by "storing patient identity,
medication and clinical device configuration data",
(ii) the
text "data comprising patient data" has been replaced by
"patient identity and medication data" in the first four occurrences
of that text,
(iii)the
last part of the claim after "wherein the second programmable
computer(45):" has been amended to
"compares
the patient identity and medication data input into the first input means (90)
with the stored patient identity and medication data and verifies that the
medication identified by the medication data input into the first input means
(90) is the correct medication for the patient identified by the patient
identity data input into the first input means (90); and
when the
verification is complete, automatically communicates clinical device
configuration data to the first programmable computer (80) to configure the
clinical device (92); wherein the clinical device comprises an infusion pump, and
wherein communicating clinical device configuration data to the first
programmable computer (80) to configure the clinical device comprise[s]
downloading appropriate configuration parameters for the infusion into the
first programmable computer (80) and then into the infusion pump (92)."
XII. The
appellant's essential arguments, insofar as relevant for the present decision,
can be summarised as follows.
Regarding
the objections of lack of clarity of the Examining Division, the appellant
argued that the first and second computers were a bedside CPU and a remote
computer, respectively. Having a single server and connecting the hardware to
it directly would necessitate a rather complex system having proper interfaces
with each different connected hardware. Besides, since the hardware was remote
from the single server, it would be difficult to check whether the hardware
communicated properly with the server. Therefore, the two computers had a
technical effect.
The
invention made sure that no medication was delivered by mistake to a patient,
for example because of name similarities. It avoided mistakes by the nurse when
programming the device.
None of the
documents D1 or D2 disclosed "configuring directly a clinical device
assigned to the patient from a computer after the drug/patient verification has
been made".
The
invention went against a technical prejudice in the field of providing care,
according to which the manual input of configuration data by a professional was
necessary to add a security level to the configuration of the clinical device.
Reasons for
the Decision
Admissibility
of appeal
1. The
appeal complies with the provisions referred to in Rule 101 EPC and is
therefore admissible.
Procedural
violations
2. It
follows from the summary of the first-instance proceedings (see section II
above) that their length was affected by unacceptable delays, in particular the
delay of more than five years between the supplementary European search report
dated 18 February 1999 and the Examining Division's first communication of 7
June 2004, and the delay of more than two years between the applicant's reply
of 10 August 2007 to the third communication of the Examining Division and the
summons to oral proceedings dispatched on 8 March 2010. These delays were
pointed out in letters from the appellant who inter alia repeatedly enquired
about the further prosecution of the case.
In the
opinion of the Board, the delays cannot be justified by the particular
circumstances of the case. The duration of the first-instance proceedings of
more than twelve years after entry into the European phase must be regarded as
excessive. According to decision T 315/03, even a shorter delay of ten years in
a much more complex opposition case amounted to a procedural violation (points
15.5 and 15.6 of decision T 315/03 which was published only in an abbreviated
form in OJ EPO 2006, 15). The Board in that case found that such a delay was
not "within a reasonable time" and therefore infringed Article 6(1)
of the European Convention on Human Rights (ECHR).
The Board's
considerations in the present case are also in line with a judgment in the case
of Kristiansen and Tyvik AS v. Norway before the European Court of Human Rights
(decision of 2 May 2013 in application No. 25498/08), in which the examination
and (administrative) appeal proceedings of a patent application at the
Norwegian Industrial Property Office took a total of eighteen years before the
final decision was issued in a second appeal (which the appellant apparently
did not challenge before the Norwegian courts). The initial examination
proceedings up to the refusal of the application by the first instance in that
case took nearly eleven years (see points 4 to 16). Taking into account the
duration of patent protection of twenty years, the European Court of Human
Rights found "the length of the administrative proceedings before the
patent authorities" in that case to be excessive because it "in
effect rendered meaningless any exercise by them [the applicants] of their
right of access to a court" (see points 53 to 58 of the decision).
Although the Court recognised that the intransigent attitude of the applicant
had contributed to the length of the proceedings (points 54 and 56), it reiterated
that "in civil length cases examined under Article 6 § 1, the period to be
taken into consideration does not necessarily start when the competent tribunal
was seized but may also encompass the prior administrative phase" (point
57).
The
conclusions of that decision apply all the more to the present case since, in
contrast to the case underlying that decision, the proceedings of the first
instance in the present case were not affected by any unusual behaviour on the
side of the applicant. It is simply not acceptable that under these
circumstances the first instance refusal decision was taken more than fourteen
years after the filing date and more than twelve and a half years after the
entry into the regional phase despite the appellant's repeated attempts to
achieve an acceleration of the proceedings.
3. A
further issue concerns the reasoning given in the examination proceedings.
According to Rule 71(2) EPC any communication under Article 94(3) EPC must
contain a reasoned statement covering, where appropriate, all the grounds
against the grant of the European patent. These provisions, or the
corresponding provisions of the EPC 1973 in force during part of the
first-instance proceedings in the present case, have been interpreted by the
established jurisprudence as implying that the applicants have to be informed,
for each EPC requirement deemed not to be met, of the legal and factual reasons
why it was considered not to be met (Case Law of the Boards of Appeal of the
EPO, 7th edition 2013, IV.B.2.3.2).
3.1 In the
present case, the inventive step argumentation of the first communication
simply referred to the abstract and a passage extending over three columns of
document D1 (see also section II above). It did not discuss individual features
of claim 1 or their correspondence to features disclosed in document D1, and
did not identify the differences to the prior art.
The second
very short communication simply stated that the data received from the central
computer in the system of document D1 included identification data which was
checked, and that the check was the crucial feature of the characterising
portion of the claim. The third communication did not add any relevant
argument, simply stating that two points needed to be clarified "in order
to evaluate the technical contribution", and that "an assessment of
the technical contribution ( or 'inventive step' ) [...] can be conducted only
after the problem solved is clearly fixed in the arguments produced by the
applicant and this in order to make them valid".
The
communication accompanying the summons to oral proceedings raised objections
for lack of clarity of claim 1. The claim did not "respect the distinction
between processors and memory (storage) location" and the two processors
did not play any role. It was stated that, assuming document D1 as the closest
prior art, the feature mentioning the existence of two processors should be
included in the characterising part, contrary to the claim wording at the time.
Regarding inventive step, the Examining Division argued that the technical
contribution of the invention was the avoidance of "errors when
programming a clinical device" and that the solution could be derived from
the common knowledge. The communication mentioned for the first time that the
dependent claims lacked inventive step, but did not include any reasoning.
In the
opinion of the Board, the reasoning in those communications was insufficient.
The communications did not clearly identify the closest prior art and the
distinguishing features of the invention. None of the communications analyses
the individual features of the claim or adequately addresses the arguments of
the appellant.
4.
Regarding the decision itself, the Board notes that Rule 111(2) EPC stipulates
that decisions of the EPO open to appeal should be reasoned. According to the
established jurisprudence of the Boards of Appeal, in order to fulfil the
requirements of Rule 111(2) EPC, a decision should contain, in logical
sequence, those arguments which justify its tenor.
As further
explained in T 278/00, OJ EPO 2003, 546 (see point 2): "the conclusions
drawn from the facts and evidence must be made clear. Therefore all the facts,
evidence and arguments which are essential to the decision must be discussed in
detail in the decision including all the decisive considerations in respect of
the factual and legal aspects of the case". That decision also explains
that the reasoned decision is required to enable the appellants, and the board
of appeal in case of an appeal, to examine whether the decision could be
considered to be justified or not (see also Case Law of the Boards of Appeal of
the EPO, 7th edition 2013, III.K.4.2).
4.1 The
decision's argumentation with respect to inventive step, essentially that
reproduced in section IV above, does not discuss the individual features of the
claim. It is not clear what the closest prior art is, whether it is the common
knowledge of the skilled person or the disclosure of document D1, and what
distinguishes the invention from the prior art. The decision simply refers to
column 4, lines 48 to 55 of document D1, which discloses the automatic checking
of a patient's medication order by the system. Even though this passage is
definitely very relevant, the reasoning does not indicate how the features
disclosed in it correspond to claimed features. Some features of the claim, for
example the particular configuration of interconnected devices of the patient
care management system and the way they interact, are not disclosed in that
passage of document D1 and are not further discussed in the decision.
The minutes
of oral proceedings provide a more complete argumentation on inventive step,
explaining where each of four possible distinguishing features is disclosed in
either document D2 or in a specific passage of document D1. However, this
reasoning was not taken over in the decision.
4.2 The
decision of the Examining Division not to admit the auxiliary request is only
briefly mentioned in point 7 of the facts and submissions of the written
decision, but not in its reasons. According to that passage, the request did
not prima facie overcome the previously raised objection for lack of inventive
step (see section IV above). This reasoning is confusing and insufficient. It
exclusively mentions Articles 52(1) and 56 EPC, which however cannot serve
alone as the legal basis for not admitting a request.
4.3
Finally, the Board notes that the decision does not treat the arguments of the
appellant.
5. The
Board hence concludes that the duration of the first-instance proceedings was
excessive, the written reasoning given in the communications was inadequate,
and the contested decision is insufficiently reasoned within the meaning of
Rule 111(2) EPC. These deficiencies amount to substantial procedural
violations.
6.
According to Article 11 RPBA, a Board shall remit a case to the department of
first instance (without substantive examination) if fundamental deficiencies
are apparent in the first instance proceedings, unless special reasons present
themselves for doing otherwise.
The
excessive duration of the examination proceedings in the present case qualifies
as such a special reason. Consequently, the Board found that remitting the case
directly for formal reasons would be inappropriate.
The
invention
7. The
application relates to a patient care management system for automating administration
of medication to patients in a health-care institution.
8. The care
management system shown in Figure 1 is "configured as a local area network
with a file server 45 to which are connected a pharmacy computer 60, a nursing
station 70, and bedside CPUs 80" (see page 6, lines 22 to 24 of the
international publication).
9. A
particular mode of operation of the care management system of the invention is
described on page 18, line 10, to page 20, line 26. Each patient wears a
wristband with a bar code representing his name and other information. The
physician prepares an order for administration of a particular medication
regime and gives it to the health-care institution's pharmacy, where the
necessary medication is packaged in a container labeled, in the example using a
bar code, with the patient's name, drug name and other treatment parameters. On
page 19, lines 5 to 7, it is also stated: "The existence of this
medication order is made available by the hospital's pharmacy information
system 20 and is stored by the file server 45".
The
medication is then delivered to the appropriate unit for administering to the
patient. In order to administer the medication, a caregiver, e.g. a nurse,
carries the drug container to the appropriate patient, and reads both bar codes
of the patient and the drug container using a bar code reader attached to the
bedside computer (also referred to as "bedside CPU 80" in the
application, see e.g. page 19, lines 10 to 13). The drug container may also
include the identification of both the drug and the patient (page 11, lines 15
to 20, page 18, line 30 to page 19, line 3). Other data may have to be entered
for the verification process.
The
obtained data is analysed by the medication administration module, which
records the therapeutic regimen information for the patient and "verifies
that the right medication is being given to the right patient in the right dose
by the right route and at the right time". If a discrepancy is detected an
alert is sounded (page 19, line 28 to page 20, line 10).
10. In the
embodiment described on page 20, lines 11 to 26, the medication is to be
delivered using an infusion pump attached to the bedside computer. In that
case, "the care management system automatically downloads information
consisting of the appropriate configuration parameters for the infusion from
the pharmacy CPU 60 through the local area network 50 into the bedside CPU 80
and then into the infusion pump 92, 94 when the verification function of the
medical administration management module 110 is complete". This eliminates
one potential source of inaccuracy and the need for the caregiver to manually
enter the parameters.
11. The
following passage on page 20, line 27 to page 21, line 16, states that once the
infusion pump is configured, the caregiver starts the infusion by pressing the
appropriate control on the infusion pump. This may cause a signal to be
transmitted from the pump to the bedside computer which is then logged by the
clinical monitoring and event history module and entered by the medical
administration management module into the patient's medical administration
record.
Main
request
12. Claim 1
of the main request is directed to a patient care management system comprising
two computers in a communication network.
The first
computer, named "first programmable computer (80)" in the claim, is
to be understood as a bedside computer or "bedside CPU 80". According
to the description on page 8, lines 29 to 31, each private room, semi-private
room, or ward area has at least one bedside computer for monitoring and
treating one or more patients. The first computer is connected to input means
comprising a bar code reader and to a clinical device for delivering medication
to a patient.
According
to the claim, the second computer is configured to receive and store data
comprising patient data and clinical device configuration data. It is
furthermore configured to verify the patient data received from the first
computer with stored patient data and to automatically communicate
configuration data to the first computer to configure the clinical device.
The claim
assigns to the "second programmable computer" the reference sign 45,
which is described in the application as the central file server connected to
the network and storing information from the pharmacy information system (see,
for example, page 7, lines 25 to 31, and page 19, lines 5 to 7). According to
the passage on page 20, lines 11 to 26, the configuration parameters for the
clinical device, an infusion pump, are downloaded from the "pharmacy CPU
60". In the light of this, the Board interprets the feature "second
programmable computer" as also encompassing the "pharmacy CPU"
with reference sign 60.
13. Claim 1
of the main request covers a broader subject-matter than that described on page
20, lines 11 to 26, in that the claimed clinical device is not limited to an
infusion pump. The Board therefore assumes that it was the intention of the
applicant to cover general clinical devices and interprets the feature
accordingly.
14. In the
grounds for appeal the appellant maintained that the verification step allowed
"the second programmable computer to identify with certainty a patient and
match the identified patient with the patients in the database entered by the
pharmacist" and that the downloading step allowed "configuring
directly the clinical device assigned to the patient from the second computer,
rather than having someone such as a nurse configure the device from the
bedside" (see page 6 of the grounds of appeal).
The Board
agrees that the second computer verifies the data and controls the device.
However, the statements of the appellant imply a narrower interpretation of the
claim than is derivable from its concrete wording. In particular, the claim
does not state that the clinical device configuration data communicated to
configure the device is somehow related to the patient. The claim therefore
covers any configuration of the device.
Inventive
step
15.
Document D1 discloses a system for dispensing drugs in health-care institutions
for avoiding medication errors, reducing staffing needs, as well as providing
automatic functionality concerning inventory control, billing, patient
profiles, medication administration reports, hourly patient medication
requirements report, daily evaluation of medication due to discontinue,
drug-interaction and allergy warnings (column 2, lines 39 to 53).
16. The
system includes a central computer and dispensers, or dispenser stations,
located at nursing stations. In one disclosed embodiment, the dispenser is
operatively connected to the central computer ("computer system" in
the wording of the claims of D1) and has "a software controllable,
electrical interface that may receive data from the central computer"
(column 3, lines 15 to 63, claim 1, column 24, lines 16 to 42). Each dispenser
station includes a station terminal operatively connected to the central
computer and a dispensing cabinet (see claim 1, column 24). A dispenser
contains a plurality of medications that may be automatically dispensed to
authorized personnel on demand. No medications are dispensed without
verification and authorization (column 4, lines 28 to 32; claims 1 and 3).
Medication orders are entered into the central computer via the pharmacy
terminals (column 4, lines 38 to 46; claim 1, column 24, lines 37 to 42).
Therefore,
document D1 discloses a patient care management system similar to that of the
claimed invention and used for the same purpose. From the above explanation it
follows that the system of document D1 includes first and second computers
connected by communicating means, each including input means, and that the
first computer (terminal of a dispensing station) is connected to a clinical
device (dispenser or dispensing cabinet) for delivering medication to a patient
as in the claimed invention. The second computer in D1 (central computer or
computer system) records medical treatments.
In the
Board's opinion, the dispenser or dispensing cabinet of document D1 is a
clinical device for "delivering medication to the patient" within the
meaning of the claim. As explained in point 13 above, the clinical device of
the claim is not limited to an infusion pump. The dispensing cabinet of
document D1 is used to dispense medication in a clinical environment for the
purpose of delivering a specific dispensed medication to a corresponding
patient. Since the dispensed medication has to be carried to the patient, the
dispenser is not used to administer the medication directly to the patient in
the same way an infusion pump does. However, in the Board's view the claim is not
limited to such a "direct delivery" of medication.
17. In
order to deliver medication to a patient using the patient care management
system of document D1, a nurse requests the medication at the terminal of the
dispensing station for the specified patient. The computer system reads the
stored patient order data for the specified patient, determines the medication
scheduled to be administered and verifies the medication dispensing request
with the medication data for the specified patient (claim 1, feature (b) of the
software means, column 24, lines 62 to 68). If the verification is positive,
the dispensing cabinet is actuated to dispense the scheduled medication (see
claim 1, column 24, line 62 to column 25, line 18, and claim 3, column 25,
lines 40 to 53, and column 5, line 35 to column 6, line 2). It is clear from
claim 1 of D1 that the computer system is responsible for the verification and
for controlling the dispensing cabinet. It therefore sends device configuration
data to the terminal to configure the clinical device, in this case the
dispensing cabinet.
18. In the
grounds for appeal the appellant argued that the verification of the system of
document D1 identified medication duplication or potentially dangerous drug
interactions, but that document D1 did not "disclose or suggest any means
for making sure that no medication was delivered by mistake to a patient".
The Board
notes that, due to human intervention necessary in both cases (see sections 9
to 11 above), none of the systems can fully ensure that medication is not
delivered by mistake. Moreover, for the reasons given in point 14 above, the
system as defined in claim 1 of the main request does not necessarily have that
effect mentioned by the appellant.
The Board
nevertheless recognises that the system as described in the application sends
the appropriate configuration for the patient and contributes to avoid false
medication. However, the same is done by the system of document D1 by verifying
the medication orders for a specific patient before dispensing the medication
and stopping the dispenser cabinet from delivering medication if the result of
the verification is negative (claims 1 and 3). This objective is explicitly
mentioned in column 2, lines 39 to 53, as well as column 12, lines 45 to 54 of
document D1.
19. The
system of claim 1 of the main request therefore differs from that of document
D1 in that
- the input
means of the first programmable computer comprises a bar code reader.
20. Bar
code readers allow a more efficient and reliable way of inputting data. The
distinguishing feature hence solves the problem of facilitating the input of
patient data into the patient care management system.
21. In the
opinion of the Board, the claimed solution was obvious for the skilled person
at the priority date of the present application.
At that
time it was standard practice to use bar codes to identify patients in
hospitals and other health-care institutions, as acknowledged in the
application on page 10, line 30, to page 11, line 4. It was well known that bar
code readers allowed a faster and more reliable way of entering the patient
identification than previous solutions, for example using a keyboard.
Furthermore, such a use of bar codes is described in document D4 in the context
of a patient identification and verification system (see abstract and Figures 2
to 4).
It would
thus be obvious for the skilled person to change the input means of the system
of document D1 to the commonly known bar code readers in order to improve input
of data in the system of document D1.
22.
Consequently, the subject-matter of independent claim 1 of the main request
does not involve an inventive step (Articles 52(1) and 56 EPC).
Auxiliary
Request
23. The
subject-matter of independent claim 1 of the auxiliary request differs from
that of the main request essentially in that
- the
feature "data comprising patient data" has been amended to
"patient identity and medication data" (see amendments (i) and (ii),
section XI above),
- the
second programmable computer verifies that the medication data input is the
correct medication for the patient (amendments (i) to (iii)), and
- the
clinical device comprises an infusion pump (amendments (iii)).
Admission
of the request
24. The
Examining Division did not admit the auxiliary request into the proceedings.
According
to Article 12(4) RPBA the Board has the power to hold inadmissible requests
which were not admitted in the first-instance proceedings. Article 12(4) RPBA
is therefore applicable with respect to the auxiliary request in the present
case.
The general
principles for exercising the discretion to allow amendments are established in
the case law (see G 7/93, OJ EPO 1994, 775). In considering whether to overrule
the way in which a first instance department has exercised its discretion, the
Board should assess whether the Examining Division exercised its discretion
taking into account the right principles and in a reasonable way. This
assessment presupposes a comprehensible reasoning of the decision not to admit
a request.
25.
However, in the present case the rejection of the auxiliary request was not
properly reasoned in the written decision, as explained in point 4.24.2 above.
It can only be deduced from the decision that the Examining Division did not
admit the request because it did not consider it to be clearly allowable due to
lack of inventive step of its subject-matter.
26. In the
Board's view, the reasoning given by the Examining Division in its
communications before the oral proceedings was incomplete and almost
unintelligible (see also point 3.13.1 above). The communications did not
unambiguously identify the closest prior art and the distinguishing features.
None of the communications analysed the individual features of the claim or
treated the arguments of the appellant. The clarity objections were rather
vague. Under these circumstances, it could not be assumed that the applicant
had fully understood the objections raised before the oral proceedings and was
in a position to file allowable claims in advance of the hearing.
At the oral
proceedings the appellant heard for the first time the more complete
argumentation on inventive step, including a discussion of individual features.
The auxiliary
request submitted at the oral proceedings was a reaction to this new reasoning
and, as stated in the minutes, was considered by the Examining Division to
fulfil the requirements of Article 123(2) EPC. Furthermore, it represented a
clear improvement over the main request with respect to clarity and restricted
the subject-matter of the claim. In the opinion of the Board, given the
circumstances of the case, the applicant had the right to have this request
admitted, and the complete reasoning regarding inventive step presented,
discussed and afterwards included in the written decision.
27. In the
exercise of its discretion under Article 12(4) RPBA, the Board therefore
decides to admit the auxiliary request into the appeal proceedings.
Inventive
step
28. As
explained for the main request, document D1 discloses most of those features of
claim 1 of the auxiliary request which correspond to features of the main
request.
In the
opinion of the Board, document D1 also describes some of the additional
features relating to the input and verification of patient and medication data,
in claim 1, column 24, line 62 to column 25, line 18, and claim 3, column 25,
lines 40 to 53, as well as column 5, line 35 to column 6, line 2. These
passages disclose that not only the patient data, but also medication data,
medication history and prescriptions, are checked before dispensing medication,
and that it is verified whether the identified medication is the correct one
for the patient (see also points 15 to 18 above). Document D1 also mentions, on
column 4, lines 64 to 67, that the system schedules other medications not
stocked in the cabinet, such as intravenous medications that will be needed by
patients at a dispensing station.
29. The
subject-matter of claim 1 of the auxiliary request differs from the embodiment
of document D1 discussed above in that
(a) the
input means of the first programmable computer, the first input means, comprises
a bar code reader;
(b) the
first input means is used for inputting medication data as well; and
(c) the
clinical device comprises an infusion pump.
30. The
claimed invention therefore solves, starting from the hospital system of
document D1, the problem of further automating the delivery of medication.
31.
Document D3 discloses a programmable infusion pump. It also describes a data
transfer system for allowing monitoring of pump operation and pump
reprogramming from a remote location (abstract, column 1, lines 5 to 13).
However,
document D3 does not disclose using the infusion pump in a hospital
environment, connecting it to a hospital information system, or having it
automatically programmed on the basis of data stored in an information system.
Besides, none of the computers of the hospital information system of document
D1 controls the direct administration of medication to a patient. The Board is
therefore not convinced that the skilled person would consider the teaching of
document D3 when trying to solve the problem of further automating the system
of document D1.
32. Since
none of the other prior art documents cited in the proceedings in the present
case, documents D2 and D4, suggests such a usage of an infusion pump controlled
by a hospital information system for direct and automatic administration of
medication to a patient, the Board concludes that the subject-matter of claim 1
is inventive over that prior art.
Remittal to
Examining Division
33. Taking
into consideration the above reasons, the Board decides to remit the case for
further prosecution on the basis of the auxiliary request.
Given the
excessively long duration of the examination proceedings, the Examining
Division should expedite its final examination of the remitted case.
Reimbursement
of the appeal fee
34.
According to Rule 103(1)(a) EPC the appeal fee must be reimbursed in full
"where the Board of Appeal deems an appeal to be allowable, if such
reimbursement is equitable by reason of a substantial procedural
violation".
For the
reasons given above, the contested decision is to be set aside. The appeal is
therefore allowable within the meaning of Rule 103(1)(a) EPC.
According
to the established case law, the failure to provide adequate reasoning in a
decision in accordance with Rule 111(2) EPC is to be considered a substantial
procedural violation justifying the reimbursement of the appeal fee (see Case
Law of the Boards of Appeal of the EPO, IV.E.8.3.4). Similarly, long delays
occurring in first instance proceedings can amount to a substantial procedural
violation (see e.g. Case Law of the Boards of Appeal of the EPO, IV.E.8.3.6).
In particular, it has been held that a delay of ten years in first instance
opposition proceedings was beyond question a procedural violation (T 315/03,
points 15.5 and 15.6).
In line
with that jurisprudence, and taking into account the particulars of the present
case, the Board finds that the duration of more than twelve years of the
first-instance proceedings and the insufficient reasoning in the written
proceedings as well as in the decision amounted to procedural violations and
affected the entire procedure (see points 3, 4 and 24 to 26 above). The Board
therefore concludes that substantial procedural violations have taken place.
The Board
is also convinced that the appeal was caused by the deficient treatment of the
case in the first-instance proceedings (see points 3, 4 and 24 to 26 of this
decision) and that thus the reimbursement of the appeal fee is equitable.
Order
For these
reasons it is decided that:
1. The
decision under appeal is set aside.
2. The case
is remitted to the department of first instance for further prosecution on the
basis of the auxiliary request.
3. The
appeal fee is to be reimbursed.
It is certainly unacceptable that twelve years were needed to decide the fate of an application, moreover with communications and a decision with flimsy grounds.
ReplyDeleteThe attitude of the BA is also questionable. It took 5 years to come to a decision. Appeal in November 2010 and decision in December 2015!
Moreover, rather than to remit the case for "further prosecution on the basis of the auxiliary request", the BA could have brought the file to a close in deciding for grant on the basis of the auxiliary request as it considered that the its subject matter is inventive over the available prior art.
Remittal for further prosecution means further examination, whereby the provisions of Art 111 allowed the Board to bring the case to a close, and not to a debatable decision. Why did the Board not finish of the work?
Case T 1339/09, is very similar to the present one. The BA decided, pursuant to Article 111 not to remit to the DE, despite a substantial procedural violation brought to light by the BA itself. No requests being allowable, the appeal was rejected and therefore the rejection of the application confirmed. The application dated from 2002 and the decision of the BA was made in 2015! Here the BA duly considered the age of the application.
In opposition case T 1548/11, while deciding there was substantial procedural violation, the BA nevertheless decided not to remit as the case was very old. It is true that one the parties had asked the BA not to remit.
Why could the present BA not finish of the work properly?
The ED is certainly to blame, but BA is not free of blame either.
To the best of my knowledge, the reason why the BoA did not finish the job by granting the application is that the BoA is not equipped to complete the procedure under R.71. All the treatment of claims translation, druckexamplar, sending for publication etc... is done by Patent Administration (formalities for 1st instances), and there is no duplicate capacity in DG3 to do this. This explains that a BoA can finish the job by revoking / rejecting the application but not actually take a decision to grant (or to maintain in amended form).
ReplyDeleteThe board could have remitted with an order to grant.
DeleteWhat is said by "Anonymous" is certainly true, but then the BA could have taken in the decision an "order to grant" on the basis of the auxiliary request, and not merely state "remittal for further prosecution on the basis of the auxiliary request".
ReplyDeleteFurther prosecution does not necessarily bring the file to a close, it simply means continue the examination, even leaving open the filing of further requests "on the basis of the auxiliary request".
An order to grant on the basis of the auxiliary requests does not leave much to do, but to invite the applicant to file an adapted description, pay the due fees and file the translation of the claims. If that is what the BA intended, why did it not say so?
And remember it took 5 years to come to such an ambiguous order.
The BoA could have stated: the case is remitted with the order to grant a patent with the claims according to the auxiliary request and a description to be adapted accordingly. It didn't use these words but the substance of the order still remains the same. Adapting the description will still require additional time before the first instance but it would have also required time before the BoA if the Board had decided to do it itself: the BoA would have had to continue the proceedings in writing for adapting the description since the appellant was not present at the oral proceedings. And: the process of adapting the description in written proceedings can be carried out much more efficiently before the first instance than before the BoA! Raoul's friend
ReplyDeleteDear anonymous friend:
ReplyDeleteI agree with you, but by not giving an order to grant the BA did leave the door open for further developments.
To be honest it has always be a nuisance when a BA remits just with a set of claims and does not finish up the work.
It can end up with another OP before the first instance, just about the adaptation of the description.
Why should it be more efficient to adapt the description by the first instance than by the BA? The BA are simply not willing to do the work. One should may be go back to the Travaux preparatoires to see what the legislator had in mind when it set up Art 111. I dear think that it was not merely to allow the BA to escape some unpleasant work.... In the early days of the EPO, some BA finished the work and also adapted the description. They quickly became a dwindling minority, and eventually remittal for adaptation of the description was systematic.
I do not know German law very well, but I strongly doubt that the BPatG (Federal Patent Court) merely remits to avoid menial work. I am happy to be proved wrong on this issue!
When you look at T 2047/14, published today, you realise that if the Board had finished the work and adapted the description, this procedure would have been superfluous. After the OD had adapted the description, the opponent tried to reopen the the discussion on the validity of the claims. That this was doomed to fail is manifest in view of the notion of res judicata, but the temptation would not even have been there if the file had been closed by the BA.
ReplyDeleteOne can also wonder about the professional knowledge of the representative having filed such an appeal......
T 2047/14 is a funny case indeed.
DeleteBut are you sure the appellant in that case would not have appealed if in its first decision the BOA had remitted the case with an adapted description and ordered the OD to maintain the patent on a fully specified amended text? It seems to me there would have been exactly the same temptation.
If the work is completely finished at the BA, i.e. with payment of the fee and filing of the translations of the claims, then there is no temptation whatsoever to behave as suggested.
DeleteArt 111(1) does not limit the competence of the BA to decide the wording of the claims.
If the complete text of the patent to be maintained is remitted, then it is even more stupid to try to go against the decision of the Board.
It is still a mystery to me, why a "professional" representative indulges in such (mis)behaviour.