DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s amendment filed 06/25/2026 has been accepted and entered. Applicant’s amendments to the claims have overcome the previous 101 rejections and the previous 101 rejections have been withdrawn.
Applicant's arguments filed 06/25/26 have been fully considered but they are not persuasive.
Applicant argues that the claimed subject matter “relates to monitoring a system comprising multiple instillation devices (i.e., multiple dialysis machines and at least a water treatment system) for leakages.” However, this is not found persuasive. The claims as currently written require a dialysis system comprising a plurality of hydraulically connected components and a control device. This limitation does not need to be interpreted as narrowly as Applicant alleges, as the claims do not require the presence of multiple dialysis machines but instead only requires a plurality of “components.” “Components” can be broadly interpreted as parts of a dialysis system. Based on this interpretation, Brauer discloses the claimed limitations as set forth below. Brauer does monitor the deviation of the actual resource consumption from the expected resource consumption to identify a leakage, as described in ¶ [0011-0012] of Brauer.
Applicant did not specifically argue the dependent claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brauer et al (US 2004/0040620).
Regarding Claim 1, Brauer discloses a method of operating a dialysis system comprising a plurality of hydraulically connected components (chambers 122 and 123, Fig. 1; ¶ [0001-0010, 0023-0024]) and a control device (analysis and processing device 27, Fig. 1; ¶ [0023-0024]), the method comprising the steps of:
receiving, by the control device (27, Fig. 1), component operating data from the components (122 and 123, Fig. 1) via a data connection with each component (¶ [0023]; a pressure gauge is located on each balancing chamber, and each pressure gauge is connected to the analysis and processing device), the component operating data comprising at least demand data for an upcoming task to be performed by the respective component (¶ [0001-0010]; volume of the chambers can be considered the demand data as the chambers are filled during the dialysis procedure);
determining an expected resource consumption of the component based on the demand data (¶ [0001-0010]; the filling times of a generic device/generic chambers is the expected resource consumption);
monitoring, by the control device (27, Fig. 1), of an actual resource consumption of the components (¶ [0010]; determining actual filling times of the chambers);
determining, by the control device (27, Fig. 1), a deviation of the actual resource consumption from the expected resource consumption (¶ [0010-0011]); and
detecting, by the control device (27, Fig. 1), a leakage in the dialysis system if the deviation is outside a predetermined range (¶ [0011-0012]).
Regarding Claim 2, Brauer discloses the expected resource consumption is represented by one or more demand parameters (¶ [0011-0012]; predetermined filling time) and the actual resource consumption is represented by one or more consumption parameters (¶ [0011-0012]; actual filling times), wherein in each case a demand parameter and a consumption parameter form a parameter pair and the deviation is determined for at least one of the parameter pairs (¶ [0011-0012]).
Regarding Claim 3, Brauer discloses a deviation of the actual resource consumption from the expected resource consumption is determined for several parameter pairs and a leakage is detected if at least a predetermined number of the deviations lies outside a predetermined range for the parameter pair (¶ [0010-0013]; the leak detection signal can be generated a second time only if the predetermined time difference is exceeded several times).
Regarding Claim 4, Brauer discloses a deviation of the actual resource consumption from the expected resource consumption is determined for several parameter pairs and a leakage is detected if at least one of the deviations is outside a predetermined range for the parameter pair (¶ [0010-0013]).
Regarding Claim 5, Brauer discloses the components (122 and 123, Fig. 1) comprises one or more consumers (122 and 123, Fig. 1; ¶ [0017-0020]) and wherein monitoring of actual resource consumption comprises the control device receiving, for each of the consumers, data indicating an actual fluid withdrawal quantity (¶ [0017-0020]).
Regarding Claim 6, Brauer discloses the monitoring of the actual resource consumption comprises a balancing of an inflowing fluid volume of fluid flowing into a ring system and an outflowing fluid volume of fluid flowing out of the ring system (¶ [0023-0024]; pressure gauges on each half of both chambers are able to determine actual filling level of the chambers; Fig. 1 shows the system is connected in a ring like manner).
Regarding Claim 7, Brauer discloses the method comprises the control device (27, Fig. 1) receiving measurement data from one or more components of the dialysis system on the inflowing fluid volume and on the outflowing fluid volume and performs the balancing based thereon (¶ [0023-0024]; pressure gauges on each half of both chambers are able to determine actual filling level of the chambers).
Regarding Claim 8, Brauer discloses monitoring of the actual resource consumption comprises monitoring of a development over time of the actual resource consumption, and wherein determining a deviation comprises determining a deviation of the development over time of the actual resource consumption from the development over time of the expected resource consumption (¶ [0010-0012]).
Regarding Claim 9, Brauer discloses the method comprises receiving, by the control device (27, Fig. 1), data from at least one external information system and detecting the leakage taking into account the data received from the external information system (¶ [0010-0011]; expected filling times are received from an analysis of a generic device).
Regarding Claim 10, Brauer discloses an exchange of data, initiated by the control device (27, Fig. 1) between at least two of the components indirectly via the control device (¶ [0010-0012, 0023-0024]).
Regarding Claim 11, Brauer discloses at least some of the components are only hydraulically connected to one another (¶ [0001-0010, 0017-0023]; Fig. 1).
Regarding Claim 12, Brauer discloses the components (122 and 123, Fig. 1) comprise at least one dialysis machine (¶ [0017-0023]; the balancing chamber can be considered a machine within the dialysis system).
Regarding Claim 13, Brauer discloses a dialysis system (¶ [0001-0010, 0017-0019], Fig. 1) configured to carry out the method according to claim 1, the dialysis system comprising:
a plurality of hydraulically connected components (chambers 122 and 123, Fig. 1); and
a control device (27, Fig. 1) connected to the hydraulically connected components by a data connection (¶ [0023-0024]).
Regarding Claim 14, Brauer discloses a memory that stores instructions that when executed by the control device (27, Fig. 1) cause the dialysis system to perform the steps of claim 1 (¶ [0010-0011, 0023-0024]).
Regarding Claim 15, Brauer discloses a non-transitory computer readable medium (memory that stores the program executed by the computer; ¶ [0010-0011, 0023-0024) that stores instructions that, when executed by one or more processors (27, Fig. 1), cause operations comprising:
receiving component operating data from the components (122 and 123, Fig. 1) via a data connection with each component (¶ [0023]; a pressure gauge is located on each balancing chamber, and each pressure gauge is connected to the analysis and processing device), the component operating data comprising at least demand data for an upcoming task to be performed by the respective component (¶ [0001-0010]; volume of the chambers can be considered the demand data as the chambers are filled during the dialysis procedure);
determining an expected resource consumption of the component based on the demand data (¶ [0001-0010]; the filling times of a generic device/generic chambers is the expected resource consumption);
monitoring of an actual resource consumption of the components (¶ [0010]; determining actual filling times of the chambers);
determining a deviation of the actual resource consumption from the expected resource consumption (¶ [0010-0011]); and
detecting a leakage in the dialysis system if the deviation is outside a predetermined range (¶ [0011-0012]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781