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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). A certified copy of Parent Application 10 2024 103 671.0, filed in Germany on 09 February 2024 has been received.
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 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) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless—
(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; or
(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 9, 10, 12, 13 and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yik; Kelly et al. ( US 20170092227 A1).
Regarding claim 1, Yik discloses a method for operating a dialysis machine (¶ [0001], [0005], [0009], a method for automated dimness control of a medical device; ¶ [0018] FIG. 1 … The dialysis system may be a peritoneal dialysis (“PD”) system 100);
the dialysis machine having a normal operating mode, in which the dialysis machine needs a normal requirement of at least one operating resource supplied to the dialysis machine; and an eco operating mode, in which the dialysis machine needs an eco requirement of the at least one operating resource supplied to the dialysis machine, which is reduced relative to the normal requirement (¶ [0020] The PD machine 102 includes a control unit 140 (e.g. a processor) and one or more sensors, such as a proximity sensor 151 and/or a motion sensor 152, that may detect the presence and/or motion of a nearby user … The control unit 140 includes automated dimness control features that control the dimness/brightness of the display 118 based on inputs received from the proximity sensor 151 and/or the motion sensor 152);
the method comprising the step of operating the dialysis machine as a function of at least one criterion either in the normal operating mode or in the eco operating mode (¶ [0023] Once a period of machine interface inactivity surpasses either the preset value or the value set in service mode, and if the machine is in an alarm-free condition, the machine display automatically enters a dimmed state; ¶ [0024] In an embodiment, the machine display in a dimmed state may display the clock time. Additionally and/or alternatively, the machine display in a dimmed state may display the clock time and the machine treatment clock to convey the duration of the therapy. In another embodiment, the machine display in a dimmed state may display the treatment clock in addition to a background screensaver; ¶ [0026], In this embodiment, the machine display may require the following conditions to enter a dimmed state: a) an alarm-free condition, b) a period of machine interface inactivity … and/or c) where a lack of movement is detected by the proximity sensor).
Regarding the claimed operating resource and criterion, Yik reduces the power consumption on the machine display by dimming it (¶ [0003], these displays may consume a significant amount of power; ¶ [0004], automatically dimming the machine display, such as to reduce machine power consumption). Yik monitors for the proximity or movement of an operator as criteria for dimming the display (¶ [0007], The display dimness control device includes at least one sensor that includes a motion sensor and/or a proximity sensor; ¶ [0010], (iii) when movement and/or user proximity is detected by the at least one sensor in the vicinity of the medical device; ¶ [0020], one or more sensors, such as a proximity sensor 151 and/or a motion sensor 152, that may detect the presence and/or motion of a nearby user).
Regarding claims 2-5, 9, 10, 12, 13, 16 and 17, Yik further discloses the steps of: monitoring the at least one criterion for activation either of the normal operating mode or of the eco operating mode; and activating either the normal operating mode or the eco operating mode as a function of the at least one criterion, in order to subsequently operate the dialysis machine as a function of the at least one criterion either in the normal operating mode or in the eco operating mode (¶ [0023] Once a period of machine interface inactivity surpasses … and if the machine is in an alarm-free condition, the machine display automatically enters a dimmed state; ¶ [0026], In this embodiment, the machine display may require the following conditions to enter a dimmed state: a) an alarm-free condition, b) a period of machine interface inactivity … and/or c) where a lack of movement is detected by the proximity sensor);
further comprising the steps of: monitoring the at least one criterion for switching between the normal operating mode and the eco operating mode; and switching between the normal operating mode and the eco operating mode as a function of the at least one criterion, so that the dialysis machine is subsequently operated as a function of the at least one criterion either in the normal operating mode or in the eco operating mode (¶ [0023] Once a period of machine interface inactivity surpasses … and if the machine is in an alarm-free condition, the machine display automatically enters a dimmed state; ¶ [0026], In this embodiment, the machine display may require the following conditions to enter a dimmed state: a) an alarm-free condition, b) a period of machine interface inactivity … and/or c) where a lack of movement is detected by the proximity sensor);
wherein the step of switching between the normal operating mode and the eco operating mode takes place automatically (¶ [0020], The control unit 140 includes automated dimness control features that control the dimness/brightness of the display 118 based on inputs received from the proximity sensor 151 and/or the motion sensor 152);
wherein the step of switching between the normal operating mode and the eco operating mode takes place manually (¶ [0007], The state of the medical device may include an alarm-free condition of the medical device and/or a condition of manual interaction with the medical device via a machine interface; ¶ [0024], The screen saver may be either a preset screen saver or, alternatively, a screen saver selected from a group of available screen savers selectable in service mode; ¶ [0039], Accordingly, for example, recognition of user gestures at the medical device may correspond to conditions in which machine interface activity is detected (see, e.g. step 507 of FIG. 5));
further comprising the step of displaying a visual parameter on an electronic display device of the dialysis machine to show a current operating mode of the dialysis machine (¶ [0024], In yet another alternative embodiment, the machine display in a dimmed state would display the clock time and the machine status bar to convey machine state and information messages not considered to be alarms or warnings (e.g. Online Clearance Tests, Filling Programs, and Online Pressure Holding Tests for a Hemodialysis machine); ¶ [0033] FIG. 4 … The display 400 is dimmed except for a treatment status bar 401 and a clock time 402 that are illuminated. As the therapy progresses, the treatment status bar 401 displays machine state and informs the operator of the initiation of background processes such as Online Clearance Tests; ¶ [0036], In the event of an alarm or warning (Yes—a step 506), the proceed proceeds to step 509 where the machine display exits the dimmed state to convey alarm or warning information to the operator and the process then returns to step 501);
wherein the visual parameter is a display brightness and/or a color scheme (¶ [0020], The control unit 140 includes automated dimness control features that control the dimness/brightness of the display 118 based on inputs received from the proximity sensor 151 and/or the motion sensor 152);
wherein the electronic display device is touch-sensitive (¶ [0006], machine interaction may be monitored (e.g. … the machine display in the case of a touch screen, or the like); ¶ [0018], The PD machine 102 also includes a user interface such as a touch screen display 118 and additional control buttons 120);
further comprising the step of detecting a quantity for the at least one criterion with a sensor device, the sensor device comprising: a brightness sensor for detecting an ambient brightness of the dialysis machine, and/or a proximity sensor for detecting a person who is approaching the dialysis machine, and/or a contact sensor for detecting a tactile input of a quantity for the at least one criterion (¶ [0023] Once a period of machine interface inactivity surpasses … and if the machine is in an alarm-free condition, the machine display automatically enters a dimmed state; ¶ [0026], In this embodiment, the machine display may require the following conditions to enter a dimmed state: a) an alarm-free condition, b) a period of machine interface inactivity … and/or c) where a lack of movement is detected by the proximity sensor);
wherein: the eco operating mode is based relative to the normal operating mode on at least one of the following eco measures: reducing a dialysate flow rate of a dialysate passed through the dialysis machine, reducing a display brightness of a display device of the dialysis machine, adapting a colour scheme of the display device, deactivating the display device, reducing a flushing temperature during flushing of the dialysis machine, or extending a hot-cleaning duration and correspondingly reducing a hot-cleaning temperature during hot cleaning of the dialysis machine (¶ [0020], The control unit 140 includes automated dimness control features that control the dimness/brightness of the display 118 based on inputs received from the proximity sensor 151 and/or the motion sensor 152);
further comprising the step of configuring the eco operating mode by a selection and/or combination of eco measures for the eco operating mode (¶ [0006], In an implementation, the functionality of the automated display dimness feature may be activated or deactivated through a service mode setting. Alternatively, the automated display dimness feature may be a default feature. Additionally, the duration of machine interface inactivity before having the machine display enter a dimmed state may be adjustable through a service mode setting¶ [0022], In an embodiment, the functionality of the automated display dimness feature may be activated or deactivated through a service mode setting; ¶ [0024], One of the above-noted embodiments for the displayed information on the machine display in a dimmed state may be a preset option, or alternatively, a service mode setting may be provided that allows for the selection of one of these four embodiments of the machine display in a dimmed state).
Regarding claims 18-20, Yik discloses a method wherein: the dialysis machine comprises an interface for connection to a superordinate control system fed with external data (¶ [0020] The PD machine 102 includes a control unit 140 (e.g. a processor) and one or more sensors, such as a proximity sensor 151 and/or a motion sensor 152, that may detect the presence and/or motion of a nearby user); and
the method further comprises the step of inputting the at least one criterion and/or a quantity for the at least one criterion through the interface (¶ [0020], The control unit 140 can receive signals from and transmit signals to the touch screen display 118, the control panel 120, the proximity sensor 151, the motion sensor 152, and the various other components of the PD system 100);
a dialysis machine comprising an electronic control device configured to carry out the method according to claim 1 (¶ [0020] The PD machine 102 includes a control unit 140 (e.g. a processor));
a dialysis system comprising: a dialysis machine according to claim 19; and a superordinate control system connected to an interface of the dialysis machine (¶ [0020] The PD machine 102 includes a control unit 140 (e.g. a processor); ¶ [0041] Software implementations of aspects of the system described herein may include executable code that is stored in a computer-readable medium and executed by one or more processors).
Regarding the interface and superordinate control system, Yik describes a control unit 140 and further discloses that the system may comprise one or more processors (¶ [0041]). The multiple processors and sensors necessarily include electronic connections that transfer data between each of these components. For example, electronic sensors connect via wires or other conductors to send information back to a processor. Similarly, processors or microcontrollers connect to each other via cables, ribbons or printed circuits inside a housing that contains the system’s electronic hardware. These connections are interpreted as analogous to the claimed interface.
Yik incorporates Wang; Fei et al. (US 20140267003 A1) by reference (¶ [0039], For a discussion of features of non-contact, gesture-based control systems for dialysis machines and/or other medical devices, reference is made to US 2015/0253860 A1 to Merics et al., US 2014/0266983 A1 to Christensen and/or US 2014/0267003 A1 to Wang et al., which are all incorporated herein by reference). Wang describes a system comprising multiple electronic components which interconnect by various interfaces (¶ [0036] FIG. 4 is a schematic illustration of a more detailed implementation 300 of the dialysis machine 102 according to an embodiment of the system described herein).
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Caluya; Roger et al. (US 20200222611 A1).
Regarding claim 1, Caluya discloses a method for operating a dialysis machine (¶ [0002], [0008], [0033], the systems and methods described herein can allow a dialysis system to operate in alternative environments; ¶ [0047], FIG. 1 … The hemodialysis system 100 includes a hemodialysis machine 102);
the dialysis machine having a normal operating mode, in which the dialysis machine needs a normal requirement of at least one operating resource supplied to the dialysis machine (¶ [0055] The dialyzer 110 serves as a filter for the patient's blood; ¶ [0083] In some examples, a hemodialysis system may be configured to be operated in a typical medical facility with access to electricity and clean water. The hemodialysis system may be powered by electricity provided by a conventional outlet); and
an eco operating mode, in which the dialysis machine needs an eco requirement of the at least one operating resource supplied to the dialysis machine, which is reduced relative to the normal requirement; the method comprising the step of operating the dialysis machine as a function of at least one criterion either in the normal operating mode or in the eco operating mode (¶ [0107] In some implementations, the dialysis system may be configured to operate in a low power mode. For example, in implementations in which the dialysis system is manually-powered by a generator, the generated electricity may be insufficient for completely operation of all features of the dialysis system. In such situations, the dialysis system may be configured to deactivate non-essential features in order to allow the generated electricity to sufficiently power essential features (e.g., features that are essential for patient safety)).
Regarding the operating resource and criterion, Caluya discloses that the when the machine relies on generated electricity, the machine deactivates non-essential features (¶ [0107]). Therefore, the operating resource is electricity, and the criterion is the system’s power source. The normal operating mode is analogous to Caluya’s hard-wired mode in a hospital, and the eco operating mode is analogous to Caluya’s generated electricity mode.
Regarding claims 2 and 3, Caluya discloses a method further comprising the steps of: monitoring the at least one criterion for activation either of the normal operating mode or of the eco operating mode; and activating either the normal operating mode or the eco operating mode as a function of the at least one criterion, in order to subsequently operate the dialysis machine as a function of the at least one criterion either in the normal operating mode or in the eco operating mode (¶ [0107] For example, in implementations in which the dialysis system is manually-powered by a generator … In such situations, the dialysis system may be configured to deactivate non-essential features in order to allow the generated electricity to sufficiently power essential features);
further comprising the steps of: monitoring the at least one criterion for switching between the normal operating mode and the eco operating mode; and switching between the normal operating mode and the eco operating mode as a function of the at least one criterion, so that the dialysis machine is subsequently operated as a function of the at least one criterion either in the normal operating mode or in the eco operating mode (¶ [0107] For example, in implementations in which the dialysis system is manually-powered by a generator … In such situations, the dialysis system may be configured to deactivate non-essential features in order to allow the generated electricity to sufficiently power essential features).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Caluya; Roger et al. (US 20200222611 A1).
Regarding claim 9, Caluya further discloses a step of displaying a visual parameter on an electronic display device of the dialysis machine (¶ [0057] The hemodialysis machine 102 includes a user interface with input devices such as a touch screen 118 and a control panel 120).
Caluya does not explicitly show a current operating mode of the dialysis machine on the display. However, Caluya calls for displaying information on the touch screen (¶ [0057], The touch screen 118 displays information to the operator of the hemodialysis system 100; ¶ [0058] The hemodialysis machine 102 also includes a control unit 101 (e.g., a processor) configured to receive signals from and transmit signals to the touch screen 118 ).
Showing the dialysis machine’s current operating mode would have been obvious since it constitutes one of the machine’s essential details, such as flow rates, fluid levels, pressures or remaining battery life. In contrast, not displaying the current operating mode would force the operator to guess or deduce the operating mode from other information.
Regarding claim 12, Caluya discloses that the electronic display device is touch-sensitive (¶ [0057] The hemodialysis machine 102 includes a user interface with input devices such as a touch screen 118 and a control panel 120; ¶ [0058] The hemodialysis machine 102 also includes a control unit 101 (e.g., a processor) configured to receive signals from and transmit signals to the touch screen 118).
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Yik; Kelly et al. (US 20170092227 A1) in view of Caluya; Roger et al. (US 20200222611 A1).
Regarding claim 6, Yik does not explicitly disclose that in the eco operating mode, the dialysate flow rate is less than in the normal operating mode. Caluya discloses that during operation of the dialysis machine: a dialysate is passed through the dialysis machine with a dialysate flow rate (¶ [0054], As noted above, the fresh dialysate is circulated through various dialysate lines and dialysate components, including the dialyzer 110, that form the dialysate circuit; ¶ [0055], The dialysate passes through the dialyzer 110 along with the blood, as described above … The spent dialysate is routed from the dialyzer 110 to a drain; ¶ [0114] The hemodialysis machine 500 includes a pump 522 (e.g., a blood and dialysate pump) that is configured to circulate blood and dialysate through a blood circuit and a dialysate circuit of the dialysis machine 500); and
the eco operating mode has a dialysate flow rate (¶ [0124] While the hemodialysis machine 500 is shown as including a manual-powered generator 502 and a separate pump 522, in some implementations, the manual-powered generator 502 may itself act as a pump for pumping one or both of blood and dialysate through the hemodialysis machine 500 … For example, the manual pump may include one or more valves (e.g., one-way valves) that are configured to control the flow rate of blood and/or dialysate).
Caluya does not explicitly disclose whether the dialysate flow rate in the eco operating mode is less than in the normal operating mode. However, Caluya discloses that in the eco operating mode, an operator manually powers a pump that propels the dialysate (¶ [0114], [0124]). Caluya further discloses valves that regulate the flow rates of fluids through the dialysis machine (¶ [0124], For example, the manual pump may include one or more valves (e.g., one-way valves) that are configured to control the flow rate of blood and/or dialysate. The valves may be configured to maintain the flow rate of blood to and from the patient within acceptable limits).
This implies that during the eco operating mode, both the blood and dialysate flow rates are no higher than during the normal operating mode. The alternative power sources (e.g. the operator’s physical ability to continually rotate a pump or generator; the solar panel’s maximum output) also limit the dialysate flow rate during the eco operating mode.
Caluya enables a dialysis session to proceed without connecting to the power grid, and also reduces the machine’s power consumption. One would be motivated to modify Yik with Caluya’s lower eco mode dialysate flow rate to reduce its power requirements and/or so that the system can operate without access to corded electrical power. Therefore, it would have been obvious to modify Yik with Caluya’s lower eco mode dialysate flow rate in order to reduce the machine’s power consumption.
Regarding claims 7 and 8, Yik and Caluya are silent whether the dialysate flow rate is in a range of 100 ml/min to 800 ml/min and whether the dialysate flow rate in the eco operating mode is 1.0 times to 1.6 times a blood flow rate of blood dialysed by the dialysis machine.
The dialysate flow rate and dialysate-to-blood flow ratio are interpreted as a result-effective variables, subject to experimentation and testing. A result-effective variable is a parameter which achieves a recognized result. These results are obtained by the determination of optimum or workable ranges of said variable through routine experimentation. The dialysate flow rate and ratio determine how quickly a patient’s blood can be cleansed, and also how much effort the operator must exert routine experimentation.
Too low
Not enough dialysate will flow to remove toxins from the blood
Optimized range
Toxins and waste products will migrate from blood into the dialysate via osmosis at an acceptable rate
Too high
The operator will have to exert too much effort to manually rotate the pump
Therefore, it would have been obvious to adjust the dialysate flow rate and dialysate-to-blood flow ratio in order to efficiently remove toxins during a dialysis session without fatiguing the operator. See MPEP 2144.05(II)(A,B). Also see in re Boesch and Slaney, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Yik; Kelly et al. (US 20170092227 A1) in view of Miller; Joshua James et al. (US 20130310726 A1).
Regarding claim 11, Yik does not explicitly deactivate the electronic display device in the eco operating mode. Miller discloses an electronic display device that is deactivated in an eco operating mode (¶ [[0310] FIG. 36B illustrates display tab 3606 in system settings screen 3600 displayed on a clinician's display device 192. At the display tab 3606, the clinician can specify a day brightness level 3622, a night brightness level 3624 and display auto-off 3626, which sets whether the display of machine 100 … goes into a hibernate mode after a certain period of time).
Miller reduces a display’s power consumption by turning it off entirely when the display does not need to be visible. One would be motivated to modify Yik with Miller’s display deactivation to further conserve power when the device is in its eco operating mode. A skilled artisan would have been able to modify Yik with Miller’s hibernate feature by adding a hibernate mode to Yik’s configuration options. Therefore, it would have been obvious to modify Yik with Miller’s screen deactivation or hibernate feature in order to save more energy during the eco operating mode.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Yik; Kelly et al. (US 20170092227 A1) in view of Persson; Patrik et al. (US 20230256150 A1, published earlier as IT 202000016756 A1).
Regarding claims 14 and 15, Yik discloses normal and eco operating modes as discussed for claim 1 above. Yik does not explicitly disclose a flushing mode or a hot-cleaning mode. Persson discloses a disinfection system and method for a blood treatment apparatus (¶ [0001], [0002], [0019], [0034] A first aspect refers to a thermal disinfection system (1) including a blood treatment apparatus (10));
comprising a dialysis machine (¶ [0035], dialyzer (150));
wherein: the dialysis machine has a flushing mode for flushing of the dialysis machine with a flushing liquid (¶ [0040] the blood treatment apparatus (10) comprising a control unit (500) configured to perform a thermal disinfection procedure; ¶ [0041] receiving the temperature signal; ¶ [0043] driving the heating unit (104) to heat up the fluid));
wherein the flushing liquid is passed through the dialysis machine with a normal flushing temperature and with a flushing liquid flow rate (¶ [0043] driving the heating unit (104) to heat up the fluid based on the measured temperature value T.sub.fluid_mes, and on the measured local atmospheric pressure value P.sub.atm; ¶ [0135], the hydraulic circuit (100) comprises at least one pump (120, 122; 450), the control unit (500) being configured to activate, during the thermal disinfection procedure, the at least one pump (120, 122; 450) to determine flowing of the heated fluid within the hydraulic circuit (100)); and
the flushing liquid is passed through the dialysis machine with at a range of temperatures (¶ [0106] driving the heating unit (104) to heat up the fluid to the set temperature (T.sub.fluid_set); ¶ [0107] receiving a set disinfection dose (A.sub.0_set); ¶ [0109] calculating, during the disinfection procedure, an achieved disinfection dose (A.sub.0_achieved); ¶ [0110] comparing the achieved disinfection dose (A.sub.0_achieved) with the set disinfection dose (A.sub.0_set); ¶ [0233] The mathematic formula for calculation of A0 is as follows … As an example, A.sub.0=600 may be achieved by 10 min at 80° C., or by 1 min at 90° C. or by 100 min at 70° C. FIG. 6 shows a diagram with the relationship between time and temperature for A.sub.0=600. For sterilization of medical devices, values of A.sub.0 comprised between 600 and 3000 may be used: anyhow, lower or higher values of A.sub.0 may be set according to the need; ¶ [0235] FIG. 6 shows the evolution of time, in minutes, required to complete a disinfection procedure as a function of the fluid temperature T.sub.fluid_set according to the equations 1 and 2, wherein the set disinfection dose A0_set is 600. The higher the fluid temperature, the lower is the time required for the disinfection procedure to be carried on).
Regarding an eco flushing temperature or eco hot-cleaning temperature that is less than the normal flushing / hot-cleaning temperature, Persson describes at least two ways that the temperature is altered. First, the equation [1] and Fig. 6 show that any desired A0 may be achieved by combining a range of temperature and duration values. Two temperatures can achieve the same A0 by applying them for appropriate durations. Second, the A0 value itself can be adjusted based on need, which adjusts the temperatures required to achieve the A0 value (¶ [0233]).
Regarding the hot-cleaning mode and hot-cleaning duration, Persson describes a flushing mode as discussed above. Claims 14 and 15 depend on claim 1 in parallel, therefore Persson’s disinfection mode is cited as analogous to each of these features.
Persson reduces the risk of infections from a blood treatment system without introducing hazardous chemical disinfection agents into the system (¶ [0008], [0231]). One would be motivated to modify Yik with Persson’s flushing mode or hot-cleaning mode to minimize the risks of infection from an extracorporeal treatment. Therefore, it would have been obvious to modify Yik with Persson’s flushing mode or hot-cleaning mode in order to protect patients by disinfecting the dialysis machine.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781