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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim is considered vague and indefinite because in line 8 applicant recites “an expected resource consumption.” It is unclear if the limitation in line 8 refers to the expected resource consumption recited in line 5 or a different expected resource consumption. For examination purposes, the limitation in line 8 will be considered to refer to the expected resource consumption recited in line 5 and thus recite “[[an]]the expected resource consumption.” Appropriate action required.
Claims 2-15 are rejected as depending from a rejected base claim.
Claim Rejections - 35 USC § 102
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.
Claims 1-5 and 8-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hertz (US 2013/0274644).
Per claim 1, Hertz teaches a method of operating a dialysis system ([0032] The dialysis machine may, e.g., be configured for one of hemodialysis, hemodiafiltration, hemofiltration and peritoneal dialysis.) comprising a plurality of components that are hydraulically connected (Fig. 1; [0070] FIG. 1 is a schematic view of a dialysis system 1 for hemodialysis treatment. The system defines an extracorporeal blood path 2, which extends from an access device (not shown) for blood extraction from a human or animal subject, via a blood pump 3, through a filtration unit 4 and back to an access device (not shown) for blood reintroduction into the subject.) and a control device (10; [0074] The dialysis system 1 also includes a machine controller 10, which is configured to control the dialysis process by means of one or more operational components, such as the blood pump 3, the dialysis fluid pump 7, the system 6 for preparation of dialysis fluid, etc. The machine controller 10 operates on control settings which are provided by a logic device 11. The machine controller 10 is also configured to respond to inputs from various sensors, such as the above-mentioned pressure sensors. The machine controller 10 typically also implements one or more safety functions that detect system malfunction or hazardous situations and take appropriate action.); the method comprising:
receiving, by the control device, component operating data from at least one component of the plurality of components (Fig. 3, [0137] In step 31, the process obtains the predetermined values of the machine-related parameters and the above-mentioned overall limits.), the component operating data comprising at least demand data indicating an expected resource consumption of the at least one component for an upcoming task to be performed by the at least one component (Fig. 3; [0136] Often, the session duration T is the most important setting parameter for a user. FIG. 3 illustrates an embodiment of the step 22 of determining control settings, while optimizing the session duration. The illustrated embodiment includes a calculation process that involves a sequence of steps 31-34 which first calculates the session duration, and then adjusts other machine-related parameters accordingly.); and
determining, by the control device, operating parameters for coordinated operation of the plurality of components in such a way that [[an]]the expected resource consumption of the dialysis system is optimized ([0136] Often, the session duration T is the most important setting parameter for a user. FIG. 3 illustrates an embodiment of the step 22 of determining control settings, while optimizing the session duration. The illustrated embodiment includes a calculation process that involves a sequence of steps 31-34 which first calculates the session duration, and then adjusts other machine-related parameters accordingly.),
wherein determining the operating parameters comprises determining, based on the component operating data and based on resource availability data and/or task prioritization data, at least one operating parameter for one or more of the plurality of components (Fig. 4A, [0152] In the foregoing example, two machine-related parameters (dialyzer type and achievable blood flow rate) were treated as fixed starting points, and one machine-related parameter (session duration) was prioritized in the calculation of control settings.; [0153] In one embodiment, all the machine-related parameters are included in the optimization data. The optimization data may comprise two different data sets: a priority order, and value definitions. The priority order is used by the logic device to prioritize in which order the machine-related parameters shall be set, while achieving the session targets. The value definitions are constraints used by the logic device to identify the available range of values for the machine-related parameters.; [0154] Referring to the above example of a hemodialysis system, the optimization data may include: session duration T, dialyzer type (e.g. optionally specified as membrane properties and area), blood flow rate Q.sub.B, dialysis fluid flow rate Q.sub.D, sodium concentration C.sub.D,Na, potassium concentration C.sub.D,K, calcium concentration C.sub.D,Ca, bicarbonate concentration C.sub.D,HCO3, and ultrafiltration rate Q.sub.UF….The value definition for dialysis fluid flow rate Q.sub.D may, e.g., be "as high as possible", "as low as possible", "maximum saturation" or "make full use of all available fluid". The value definitions for the electrolytes may, e.g., be "within overall limits". The value definition for the ultrafiltration rate Q.sub.UF may e.g. by "achieve fluid removal target", "as much as possible for a given duration" or "any".).
Per claim 2, wherein determining the operating parameters comprises a grouping of requirements of the plurality of components and/or a prioritizing of tasks to be performed ([0153] In one embodiment, all the machine-related parameters are included in the optimization data. The optimization data may comprise two different data sets: a priority order, and value definitions. The priority order is used by the logic device to prioritize in which order the machine-related parameters shall be set, while achieving the session targets. The value definitions are constraints used by the logic device to identify the available range of values for the machine-related parameters.).
Per claim 3, wherein determining the operating parameters comprises determining a timing of execution of tasks ([0143] In step 33, the session duration T is calculated as: T=max(T.sub.min,W;T.sub.min,urea;T.sub.min,Na;T.sub.min,K;T.sub.min,Ca;T- .sub.min,PO4;T.sub.min,HCO3) (12); [0144] which represents the shortest time required to achieve all the session targets.).
Per claim 4, wherein determination of the operating parameters is carried out taking into account resource availability ([0157] FIG. 4C illustrates an example of optimization data for use when there is a desire to ensure that the available dialysis fluid volume is used up during the treatment session. In this example, dialysis fluid volume is added as a machine-related parameter in the optimization data. The dialysis fluid volume is set to be equal to the available dialysis fluid volume, which may be predetermined, entered by the operator, or otherwise made accessible to the dialysis system. The optimization data prioritizes the amount of dialysis fluid and duration over dialysis fluid flow rate (and other parameters).).
Per claim 5, wherein determination of the operating parameters is carried out taking into account a system configuration of the dialysis system ([0029] The control settings that are computed by the logic device may include a fixed value of a machine-related parameter and/or a temporal profile, i.e. a time-sequence of values of the machine-related parameter during the course of the treatment session or part thereof. The machine-related parameters may comprise at least one of a duration of the treatment session, a dialyzer type, a blood flow rate, a dialysis fluid flow rate, a dialysis fluid composition, an ultrafiltration rate, or any other relevant parameter for the operation of the dialysis machine.).
Per claim 8, wherein the method comprises receiving, by the control device, data from at least one external information system and determining the operating parameters taking into account the data received from the at least one external information system ([0047] In one embodiment, the logic device is further configured to obtain a data structure that defines the predetermined priority order. Thereby, the logic device may be tailored to many different environments, such as in-center, at home, at hospital, etc. The data structure, which may be obtained from an electronic memory on the dialysis machine or on a server, may e.g. be specified by the caregiver to fit the specific environment.; [0079] In another embodiment, the logic device 11 is implemented on a remote server, which is connected for communication with the dialysis machine M. To the extent that the logic device 11 communicates with the operator of the dialysis machine M, this may be done via a user interface on the dialysis machine M. The memory unit 14 may or may not be part of the dialysis machine or the server.).
Per claim 9, comprising an exchange of data, initiated by the control device, between at least two components of the plurality of components indirectly via the control device (Fig. 1; here it is shown that pumps 3 and 7 communicate directly with controller 10 and indirectly with each other via the subsequent steps/changes initiated by the controller via the pumps, such as, for example, the materials passed to/from the filtration unit 4).
Per claim 10, wherein the expected resource consumption comprises an energy consumption and/or a water consumption and/or a time consumption (Figs. 4A-4C; [0154] Referring to the above example of a hemodialysis system, the optimization data may include: session duration T, dialyzer type (e.g. optionally specified as membrane properties and area), blood flow rate Q.sub.B, dialysis fluid flow rate Q.sub.D, sodium concentration C.sub.D,Na, potassium concentration C.sub.D,K, calcium concentration C.sub.D,Ca, bicarbonate concentration C.sub.D,HCO3, and ultrafiltration rate Q.sub.UF. The value definition for session duration T may, e.g., be "as short time as possible", "always a fixed time" or "whatever time needed". The value definition for dialyzer type may, e.g., be "fixed type", "type entered by operator for session" or "any among a given set". The value definition for blood flow rate Q.sub.B may, e.g., be "fixed at normally achieved flow rate", "as high as possible", "as low as possible" or "within overall limits". The value definition for dialysis fluid flow rate Q.sub.D may, e.g., be "as high as possible", "as low as possible", "maximum saturation" or "make full use of all available fluid". The value definitions for the electrolytes may, e.g., be "within overall limits". The value definition for the ultrafiltration rate Q.sub.UF may e.g. by "achieve fluid removal target", "as much as possible for a given duration" or "any".).
Per claim 11, wherein at least some components (for example, 4, 6) of the plurality of components are only hydraulically connected to one another (Fig. 1, here it is shown, for example, that there is no direct non-hydraulic connection between filtration unit 4 and dialysis fluid source 6).
Per claim 12, wherein the plurality of components comprise at least one reverse osmosis device and/or at least one concentrate mixing system and/or at least one hot cleaning system and/or at least one dialysis machine ([0025] The predictive model may thus be seen to link the resulting patient status to the operation of the dialysis machine, and provides a computational vehicle for the logic device to compute the control settings based on the status data and the target value of the physiological parameter(s).; [0032] The dialysis machine may, e.g., be configured for one of hemodialysis, hemodiafiltration, hemofiltration and peritoneal dialysis.; [0033] The logic device may be physically separate from the dialysis machine. For example, the logic device may be implemented by software run on a separate processing unit, such as a computer or a server, which is wired or wirelessly connected to the dialysis machine. Alternatively, the logic device may be physically combined with the dialysis machine. It is also conceivable that the logic device is fully or partly implemented by software run on a processor in the dialysis machine.).
Per claim 13, Hertz teaches a dialysis system (Fig. 1) configured for carrying out the method according to claim 1, the dialysis system comprising a plurality of hydraulically connected components (Fig. 1) and a control device (10),
the control device being connected to the plurality of hydraulically connected components by a respective data connection (Abstract, The logic device also obtains status data that represents the current status of the patient prior to the treatment session, and computes the set of current control settings of the machine-related parameters, as a function of the set of therapeutic targets and the status data and at least partly based on a predictive model, which estimates the physiological response of the patient to the machine-related parameters during the treatment session.).
Per claim 14, Hertz teaches a computer program product comprising instructions that cause a dialysis system to perform the steps of claim 1 ([0033] For example, the logic device may be implemented by software run on a separate processing unit, such as a computer or a server, which is wired or wirelessly connected to the dialysis machine.; [0061] A sixth aspect of the invention is a computer program product comprising computer code which, when executed on a data-processing system, is adapted to carry out the method of the fifth aspect.).
Per claim 15, Hertz teaches a computer-readable medium on which the computer program product according to claim 14 is stored ([0169] The system memory may include computer storage media in the form of volatile and/or non-volatile memory such as read only memory (ROM), random access memory (RAM) and flash memory. The special-purpose software may be stored in the system memory, or on other removable/non-removable volatile/non-volatile computer storage media which is included in or accessible to the computing device, such as magnetic media, optical media, flash memory cards, digital tape, solid state RAM, solid state ROM, etc. The special-purpose software may be provided to the computing device on any suitable computer-readable medium, including a record medium, a read-only memory, or an electrical carrier signal. It is also conceivable that certain signal processing is fully or partially implemented by dedicated hardware, such as an FPGA, an ASIC, or an assembly of discrete electronic components (resistors, capacitors, operational amplifier, transistors, filters, etc), as is well-known in the art.).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hertz (US 2013/0274644) in view of Desouza et al. (US 2020/0061281).
Per claim 6, Hertz does not explicitly disclose wherein determining the operating parameters comprises time synchronization of the component operating data.
Desouza et al., also directed to a method of operating a dialysis system comprising a plurality of components that are hydraulically connected (Fig. 1A, [0040] Returning to FIG. 1A, blood is pumped into the treatment device 114 by an arterial blood pump 110 and pumped from the treatment device 114 by a venous blood pump 104. The illustrated configuration is common for dialysis systems, and may include all the typical incidents thereof, but differs specifically in that there are two blood pumps: the arterial blood pump 110 and the venous blood pump 104.) and a control device ([0042] Control and sensing are provided by a controller 140 which may be of any form but typically some type of programmable digital controller, for example, an embedded computer. A treatment fluid is pumped from a treatment fluid source 124 through an air detector 118 (also referred to as an air sensor) through the treatment device 114, past a waste line clamp 130, to the drain 126 (indicated by W for waste). The pumps, clamp, and all sensors may be connected for control and input by the controller 140. Drain 126 may be a drain of a plumbing system or a collection container or any other device for disposal of waste treatment fluid. Treatment fluid 124 may be dialysate, replacement fluid, or any other medicament.; .; [0189] The controller is programmed to implement a method. The method includes storing operating conditions in a data store, the operating conditions includes combinations of target average blood pressures in the treatment device and target flow rates of the treatment fluid pumps.), disclose wherein determining the operating parameters comprises time synchronization of the component operating data ([Fig. 8, [0013] At a synchronization time prior to the regulating, the target pressure is obtained and stored in a data store of the controller. The target pressure is calculated from a detected pressure on the blood and/or treatment fluid side of the membrane at a time when the inflow and outflow pumps are halted. The controller, at the synchronization time, halts the inflow and outflow pumps.; [0189] The controller is programmed to implement a method. The method includes storing operating conditions in a data store, the operating conditions includes combinations of target average blood pressures in the treatment device and target flow rates of the treatment fluid pumps.) in order to, for example, regulate fluid flow in the dialysis system and/or ensure that changes over time are limited ([0008] Synchronization may be done during a priming operation, during treatment, or both. Spot synchronization may be done after a period of time over a treatment as well. The reason for triggering a synchronization after a period of time in the absence of any other change may be, for example, changes in material properties over time or due to extended use, for example a plastic pumping tube segment may exhibit changes in characteristics over continued use during a treatment. Thus to maintain accuracy of balancing, a synchronization may be performed after a time estimated to ensure that the amount of change is limited.).
Accordingly, it would have been readily obvious for the skilled artisan to modify the method of Hertz such that it comprises wherein determining the operating parameters comprises time synchronization of the component operating data in order to, for example, regulate fluid flow in the dialysis system and/or ensure that changes over time are limited.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hertz (US 2013/0274644) in view of Rohde et al. (US 2015/0021245).
Per claim 7, Hertz does not explicitly disclose wherein determining the operating parameters comprises detecting target conflicts for operating the dialysis system based on component operating data and/or resource availability data, and/or task prioritization data, and initiating automatic conflict resolution and/or initiating a user output indicating a target conflict.
Rohde, also directed to a method of operating a dialysis system comprising a plurality of components that are hydraulically connected (Fig. 1) and a control device ([0020] According to another aspect of the present invention, which may optionally be claimed as an independent aspect, the blood treatment/dialysis system according to the present invention is provided with a central (stationary) electronic control unit (part of the data management system)), disclose wherein determining the operating parameters comprises detecting target conflicts for operating the dialysis system based on component operating data and/or resource availability data, and/or task prioritization data, and initiating automatic conflict resolution and/or initiating a user output indicating a target conflict ([0035] The data management system (central control) according to the present invention allows, in particular, communication between the treatment unit and the individual blood treatment machines. The treatment unit (reverse osmosis) has additionally supplied thereto data indicating how many blood treatment machines are connected at the time in question and how much water must consequently be provided for these machines. If there should be an abnormal discrepancy between the amount of water supplied to the line system and the amount of water (fluid) returning to the treatment unit, the control unit is adapted to automatically switch off the system and/or generate a warning signal.) in order to, for example, increase operational safety and the safety of the patient ([0035] Furthermore, the data management system according to the present invention leads to an increase in operational safety and also in the safety of the patient.).
Accordingly, it would have been readily obvious for the skilled artisan to modify the method of Hertz such that it comprises wherein determining the operating parameters comprises detecting target conflicts for operating the dialysis system based on component operating data and/or resource availability data, and/or task prioritization data, and initiating automatic conflict resolution and/or initiating a user output indicating a target conflict in order to, for example, increase operational safety and the safety of the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED PRINCE whose telephone number is (571)272-1165. The examiner can normally be reached M-W: 0900-1730.
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/FRED PRINCE/
Primary Examiner
Art Unit 1779
