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 arguments filed 02/17/2026 have been fully considered but they are not persuasive. Applicant argues that the prior art references fail to teach that “de-identified health information comprises health information that has had patient identifying information removed from the health information.” Applicant further argues that the prior arts previously applied merely teach blurring the information, where said blurring may be removed, and thus fails to teach that the information is removed. The examiner respectfully disagrees. The prior arts (Hanina) teach that the patient information “may be possible to blur or otherwise de-identify”. Thus it is interpreted that blurring is de-identifying the data, or other de-identifying methods may be used. The examiner further notes that even if applicant continues to disagree, the instant application does not blur or adjust the data itself, rather is just is provided with said data. Therefore as Hanina, previously applied, is capable of loading or otherwise using “de-identified” data (that was de-identified by the device of Hanina), and thus reads to the prior art rejection. As such the obviousness rejection is upheld.
Applicant’s arguments with respect to claim(s) 29-31 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Said claims are newly added and thus a new rejection is provided in view of said claims.
Applicant argues that the added limitation of “associate control privileges with the first credential based on at least one parameter sense by the at least one sensor” overcomes that previous rejection that the system revokes control once a hard limit (Sensed by a sensor) is reached. Applicant argues that shutting down the machine does not revoke control privileges. The examiner notes the following: First, the examiner notes that the sensor data determines if the input is therapeutically allowed, and then if allowed, the controller enables controls based on permissions. The examiner notes although different from the limitation of revoking (per previous rejection), the limitation is still read to by Tanenbaum (para. 0060). Per said citation, once a hard limit of the system is reached, as determined by sensors, the control of the system is revoked preventing further control of the device. Thus it is interpreted that sensor data allows for control privileges of Tanenbaum to be associated with the credential (per the prior art combination). Control under normal operation (under the hard limit of the prior art, or therapeutically allowed as written in the claim) is controlled by an HCP, where once the sensors sense values that are past a limit (or not therapeutically allowed) control is revoked. Thus the operation of the system is based off of sensed data where control is allowed when the sensed data is “good” (or therapeutically allowed) and control is prevented when the data is “bad” (not therapeutically allowed).
The examiner notes that claims 30 and 31 are newly added. A rejection is provided below. The examiner suggests further amending claim 31 to further explain regarding how that when maintenance is required, a technician with a technician access is provided in which PHI is revoked, and upon maintenance competition (i.e. the device determined to be operating properly), the technician access is revoked. As such said maintenance access is temporary, where said maintenance access is limited and does not include PHI. Support is found in pages 8-9 of the instant application. Said limitation differentiate the claimed limitation from the prior art references as although maintenance access is providing in which the device is turned off, there is no revocation of maintenance access after maintenance is conducted and the system is working as intended in any of the cited prior arts. However, if done after final rejection, a further search and consideration of said limitations would be required.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2,9-11,17,23,26,29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanenbaum in view of Reggiardo et al. US 2008/0103447, hereafter Reggiardo and further in view of Hanina et al. US 2020/0051244, hereafter Hanina.
Regarding claim 1, Tanenbaum discloses
A dialysis system (Fig. 1, para. 0020) comprising: a fluidics system configured to perform a dialysis treatment session for a patient (Fig. 1 tubing (8)), the fluidics system comprising: at least one sensor that senses a corresponding at least one parameter (Para. 0044); a dialyzer (Para. 0002; the examiner notes that per this citation of Tanenbaum, a dialysis system, including a dialyzer, is disclosed in which the monitoring system of Tanenbaum is used with); and at least one dialysis actuator that configures fluid flow through the fluidics system (Para. 0002; the examiner notes that per this citation of Tanenbaum, a dialysis system, including an actuator (blood is pumped through the system), is disclosed in which the monitoring system of Tanenbaum is used with) a communication subsystem configured to communicatively connect to one or more user devices (Fig. 1, transceiver (40), Fig. 3). The examiner notes that per paragraph 0025, figure 3 depicts a user interface processing device (UIP) is shown to be combined with a dialysis system, where said UIP may include a variety of interface devices such as tablets or smart phones (para. 0026) interpreted to connect with the transceiver depicted in figures 1 and 2.
Tanenbaum further discloses a controller communicatively coupled to the fluidics system and the communication subsystem (Fig. 1, controller (30)) and which: operates the fluidics system to perform the dialysis treatment session (Para. 0021); maintains data associated with the fluidics system (Para. 0007, where the system is disclosed to receive and stream or store data from the device to the remote interface device via a nontransitory compute readable medium (para. 0009)), the data comprising data types of patient health information (PHI); and non-health information (Para. 0035, where the data may be patient related data, interpreted as patient health information, and information corresponding to the medical device, interpreted as non-health information); identifies access rights associated with a first credential used by a first user device to one or more of the data types (Para. 0009,0042); communicates one or more of the data types to the first user device according to the access rights (Para. 0009,0042). The examiner notes that per paragraphs 0009 and 0042, the data stored by the system may be encrypted and may require a health care practitioner (HCP) or user to login in to access the data using authorized credentials. The examiner notes that the data is available, but some of it is encrypted. Therefore prior to entering a password to access the encrypted data, the access is limited to a subset of data (only can see the non-encrypted data). When the password is entered, the encrypted data is revealed, thus the user has access to all of the data.
Tanenbaum further discloses that a control input comprising at least a portion of a prescription attributed to a patient identifier(para. 0047). Per paragraph 0047, soft thresholds/limits are set on the remote device, where said limits are treatment parameters based on patient related variables, such as blood pressure, heart rate, or other monitored blood parameter levels. The examiner notes that as a user inputs a limit (control) comprising patient related variable to aid in the monitoring of the operation of the treatment, it is interpreted that Tanenbaum discloses a control input (setting of the limit) comprising at least a portion of a prescription (treatment limits) attributed to a patient identifier (patient related variables). See also paragraph 0008 and 0009, where the first limit is a treatment parameter.
Tanenbaum further discloses that in response to receiving a control input from the first user device: identifies a control level of control privileges associated with the first credential used by the first user device to reconfigure the fluidics system to change the dialysis treatment session (Para. 0009, 0042); monitors the at least one sensor and respective states of the at least one fluidics actuators to determine a current state of the dialysis treatment session (Fig. 9, para. 0045, where soft limits are set and monitored by the controller to give an alarm when said limit is reached, where said limit is a measured treatment parameter per para. 0008)); determines whether the control input is therapeutically allowed based on the current status of the dialysis treatment session (Para. 0045); determines whether the first user device has the corresponding control level associated with the control input (Para. 0045); and configures the fluidics system in response to the control input being both allowed therapeutically and according to the corresponding control level (Para. 0004, 0021 0043). The examiner notes that per paragraphs 0021 and 0043, the controller may be used to control the operation of the dialysis, where a HCP accesses the interface via entering credentials and monitors the system. The HCP may enter a control input to adjust the system as required (para. 0021). Further per para. 0045, and as seen in figure 9, “soft limits” may be set and the system may operate as normal (monitored by HCP) until said limits are reached, at which point the operation of the system may be changed. Therefore, as a HCP needs access credentials to log in to the interface to monitor and control the operation of the dialysis system, it is interpreted that the controller determines if control input is therapeutically allowed via said soft limiters, determines the corresponding control level via the HCP login access, and configures the system in response received by a verified HCP and in response to said limiters.
Further Tanenbaum discloses determines whether the control input is therapeutically allowed based on the current status of the dialysis treatment session, wherein a control input is therapeutically allowed if the control input falls within an acceptable range previously determined to not injure the patient or damage the fluidics system; and configures the fluidics system in response to the control input being allowed therapeutically (para. 0008,0048). Per para. 0008, 0048, “hard limits” are disclosed to be set in addition to the soft limits set on the mobile device. The hard limits is set at the machine correspond regulations and guidelines of the machine (para. 0008,0048), where when the hard limit is reached the machine suspends operation of the machine. Therefore it is interpreted that any input that falls below the hard limit is an acceptable range, so any treatment input entered of the remote device should be allowed if it is less than the hard limit. The examiner notes that as the hard limit directly correlates to guidelines of operation and the machine shuts down if said limits are reached, it is interpreted that operation past said guidelines is dangerous to the machine and/or patient.
Although Tanenbaum discloses patient identifying information (para. 00345 patient related data), and further discloses medical treatment data, Tanenbaum does not disclose that said information is de-identified.
Hanina teaches a medical control computer program and is thus considered analogous to the claimed invention. Hanina teaches that it is possible to blue or otherwise de-identify patient information from a system, such as prescription information noted (para. 0077), where said de-identification can be performed locally. Therefore. As Tanenbaum discloses that medical treatment data (which is interpreted to include an operating prescription) and Hanina teaches that prescriptions or other patient identifying information is known to be de-identified locally, it would have been obvious to on having ordinary skill in the art prior to the effective filing date of the claimed invention to de-identify the medical treatment data of Tanenbaum, as de-identifying patient data is a known technique used in the art for privacy, and applying the technique of Hanina in the same manner to the system of Tanenbaum would achieve predictable results, namely the hiding or obscuring of private health data.
Further, Tanenbaum does not specifically disclose that the control privileges being stratified in control levels of: (i) no control allowed; (ii) limited control; and (iii) full control, as Tanenbaum discloses a user login access, where said access is interpreted as having two states, denied (no control) or allowed (full control).
Reggiardo teaches the monitoring of medical infusion devices and is thus considered analogous to the claimed invention. Reggiardo teaches that medical devices as detailed within include a supervisor-controllable and user-restrictive system, where configurations of the devices may be settable by a supervisor (Para. 0053). The modifications relate to data stored on the machine for operation, where Reggiardo teaches that three permission types are created, full access such as full read/write permission (HCP), limited read/write permission (caregiver), and further limited, including no rights to modify (user). Therefore as Reggiardo teaches the use of multiple levels of operational data control in medical devices including full, limited, and none, as a means to provided restrictions to modification (i.e. a user modifying operational data set by an HCP see para. 0053) it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to add a limited access setting to the device of Tanenbaum, thus giving Tanenbaum a full, limited, and no access hierarchy.
As such Tanenbaum would be able to determine control privileges based on the permissions given to the operator (read/write, limited read/write, or read only. As detailed in para. 0053 of Reggiardo, the first access level allows for setting or locking configurations of the device, and thus it is interpreted that such access level would configure the device based on control input corresponding to a control privilege.
Per the amendments filed 02/17/2026, the examiner notes that as detailed under the response to arguments, Hanina (para. 0077) teaches that the device may blur or otherwise de-identify patient information and thus reads to the claimed limitation.
Regarding claim 2, Tanenbaum, Reggiardo, and Hanina teach
The dialysis system of claim 1, wherein the controller: accesses a prescription attributed to a patient identifier via the communication subsystem; and configures the fluidics system according to the prescription to perform the dialysis treatment session (Tanenbaum Para. 0045). The examiner notes that per Tanenbaum paragraph 0045, the system has preset limits, defined under paragraph 0006 of Tanenbaum to be patient parameters. Per paragraph 0045, the controller connects with the user interface to monitor these parameters in relation to their limit set, where the limit is interpreted as the prescription of the patient. Upon reaching a second limit, the device may signal an alarm or suspend the treatment (Para. 0007), as thus it is interpreted that the controller configures the system according to the prescription, as the controller causes shut down of the system when a predetermined limit is reached.
Regarding claim 9, Tanenbaum, Reggiardo, and Hanina teach
The dialysis system of claim 1, wherein the controller transmits one or more signals comprising de-identified health information to the first user device by: generating a graphical user interface of the dialysis treatment session that depicts de-identified health information in one or more spatially-defined field locations of the graphical user interface (Tanenbaum Fig.5). The examiner notes that as seen in figure 5, information is provided in a screen. Per paragraph 0035, displayed may include machine data (interpreted under claim 1 as non-health information), patient related data (interpreted under claim 1 to be PHI) and medical treatment data (interpreted under claim 1, in view of Hanina to be de-identified health information). The examiner notes that that as seen in the figure and para. 0035, the information of Tanenbaum is provided in boxes on a display. Per the rejection of claim 1, it was found obvious to de-identify patient treatment data, such as prescriptions, which was interpreted included in medical treatment data per the rejection of claim 1.
The examiner notes that as the boxes of figure 5 of Tanenbaum are labeled, they are interpreted to be pre-determined, and as certain data types are predetermined to be de-identified (treatment data), the locations of data to be de-identified is predetermined. The examiner notes that per the rejection of claim 1, Hanina teaches that said information is blurred, thus the UI is altered to block these spaces. Said data is then sent off the device per Tanenbaum para. 0042.
Regarding claim 10, Tanenbaum, Reggiardo, and Hanina teach
The dialysis system of claim 1, wherein the controller: in response to determining that the access rights comprise notification of the dialysis treatment session: communicates a first report indicating initiation of the dialysis treatment session to the first user device in response to beginning the dialysis treatment session; and communicates a second report indicating termination of the dialysis treatment session to the first user device in response to ending the dialysis treatment session (Tanenbaum para. 0039). The examiner notes that per paragraph 0039 of Tanenbaum, an RTD (remaining time of dialysis button) acts as a countdown timer displaying the amount of treatment time remaining. As detailed under the rejection of claim 1, as the controller controls the display of the system, it is interpreted that the controller controls the RTD button, where said button is interpreted as a first report indicating initiation of dialysis treatment, as the countdown starts once treatment begins. Further at the end of treatment, and alarm sounds and the message RTD ZERO is displayed, where the alarm with the message is interpreted as the second report indication termination of dialysis. The examiner further notes that as detailed under the rejection of claim 1, in order to access the patient data and display, the user must first enter the credentials associated with access rights.
Regarding claim 11, Tanenbaum, Reggiardo, and Hanina teach
The dialysis system of claim 1, wherein the controller: in response to determining that the current state of the dialysis treatment session comprises at least one fluidics parameter being outside of an acceptable range: associates the control input with a therapeutic response to the at least one fluidics parameter being outside of the acceptable range; identifies a particular user device of the one or more user devices having control privileges associated with the control input; connects with the particular user device using the communication subsystem; and communicates a control recommendation to the particular user device (Tanenbaum Fig.9, para. 0007,0045). The examiner notes that the second limit as detailed under paragraph 0007 is interpreted as at least one fluidics parameter being outside an acceptable range. Per paragraph 0037, upon alarm situations, a warning message is displayed for the operator and may prompt the operator for a specific action such as setting treatment parameters. The examiner notes that the alarm regarding a limit reached is interpreted as a control recommendation, as the alarm is based off of sensed parameters and requests the operator to set a treatment parameter prior to or after the alarm limit is reached (See also para. 0049). This insures smoother treatment of the operation of the device (0049). The examiner notes further that as the operator must first confirm their credentials (such as an identifying pin per para. 0050) to access the information of the system, it is interpreted that the control level associated with the device allows selection of the control of the system as well as identifies that user.
Regarding claim 17, Tanenbaum discloses
A non-transitory computer-readable medium storing program instructions that, when executed using one or more processors, cause the one or more processors to; operate a fluidics system to perform a dialysis treatment session for a patient (Fig. 1, transceiver (40), Fig. 3). The examiner notes that per paragraph 0025, figure 3 depicts a user interface processing device (UIP) is shown to be combined with a dialysis system, where said UIP may include a variety of interface devices such as tablets or smart phones (para. 0026) interpreted to connect with the transceiver depicted in figures 1 and 2.
Tanenbaum further discloses a controller communicatively coupled to the fluidics system and the communication subsystem (Fig. 1, controller (30)) and which: operates the fluidics system to perform the dialysis treatment session (Para. 0021); maintains data associated with the fluidics system (Para. 0007, where the system is disclosed to receive and stream or store data from the device to the remote interface device via a nontransitory compute readable medium (para. 0009)). The examiner notes that as the device operating the system is a controller, it is interpreted to have a set of instructions and therefore comprises a non-transitory computer readable medium.
Tanenbaum further discloses the fluidics system comprising at least one sensor that measures a corresponding at least one parameter (Para. 0044) and at least one dialysis actuator that configures fluid flow through the fluidics system (Para. 0002; the examiner notes that per this citation of Tanenbaum, a dialysis system, including an actuator (blood is pumped through the system), is disclosed in which the monitoring system of Tanenbaum is used with)
Tanenbaum further discloses that in response to receiving a control input from the first user device: identifies a control level of control privileges associated with the first credential used by the first user device to reconfigure the fluidics system to change the dialysis treatment session (Para. 0009, 0042); monitors the at least one sensor and respective states of the at least one fluidics actuators to determine a current state of the dialysis treatment session (Fig. 9, para. 0045, where soft limits are set and monitored by the controller to give an alarm when said limit is reached, where said limit is a measured treatment parameter per para. 0008)); determines whether the control input is therapeutically allowed based on the current status of the dialysis treatment session (Para. 0045); determines whether the first user device has the corresponding control level associated with the control input (Para. 0045); and configures the fluidics system in response to the control input being both allowed therapeutically and according to the corresponding control level (Para. 0004, 0021 0043). The examiner notes that per paragraphs 0021 and 0043, the controller may be used to control the operation of the dialysis, where a HCP accesses the interface via entering credentials and monitors the system. The HCP may enter a control input to adjust the system as required (para. 0021). Further per para. 0045, and as seen in figure 9, “soft limits” may be set and the system may operate as normal (monitored by HCP) until said limits are reached, at which point the operation of the system may be changed. Therefore, as a HCP needs access credentials to log in to the interface to monitor and control the operation of the dialysis system, it is interpreted that the controller determines if control input is therapeutically allowed via said soft limiters, determines the corresponding control level via the HCP login access, and configures the system in response received by a verified HCP and in response to said limiters. The hard limits is set at the machine correspond regulations and guidelines of the machine (para. 0008,0048), where when the hard limit is reached the machine suspends operation of the machine. Therefore it is interpreted that any input that falls below the hard limit is an acceptable range, so any treatment input entered of the remote device should be allowed if it is less than the hard limit. The examiner notes that as the hard limit directly correlates to guidelines of operation and the machine shuts down if said limits are reached, it is interpreted that operation past said guidelines is dangerous to the machine and/or patient.
Per the amendments filed 07/28/25 Tanenbaum further discloses identifying access rights associated with a first credential used by a first user device (Para. 0009,0042). The examiner notes that per paragraphs 0009 and 0042, the data stored by the system may be encrypted and may require a health care practitioner (HCP) or user to login in to access the data using authorized credentials. The examiner notes that the data is available, but some of it is encrypted. Therefore prior to entering a password to access the encrypted data, the access is limited to a subset of data (only can see the non-encrypted data). When the password is entered, the encrypted data is revealed, thus the user has access to all of the data. Tanenbaum further discloses communicating one or more of the data types to the first user device according to the access rights (Para. 0009,0042). The examiner notes that per paragraphs 0009 and 0042, the data stored by the system may be encrypted and may require a health care practitioner (HCP) or user to login in to access the data using authorized credentials. The examiner notes that the data is available, but some of it is encrypted. Therefore prior to entering a password to access the encrypted data, the access is limited to a subset of data (only can see the non-encrypted data). When the password is entered, the encrypted data is revealed, thus the user has access to all of the data.
Tanenbaum however does not specifically disclose that the control privileges being stratified in control levels of: (i) no control allowed; (ii) limited control; and (iii) full control, as Tanenbaum discloses a user login access, where said access is interpreted as having two states, denied (no control) or allowed (full control).
Reggiardo teaches the monitoring of medical infusion devices and is thus considered analogous to the claimed invention. Reggiardo teaches that medical devices as detailed within include a supervisor-controllable and user-restrictive system, where configurations of the devices may be settable by a supervisor (Para. 0053). The modifications relate to data stored on the machine for operation, where Reggiardo teaches that three permission types are created, full access such as full read/write permission (HCP), limited read/write permission (caregiver), and further limited, including no rights to modify (user). Therefore as Reggiardo teaches the use of multiple levels of operational data control in medical devices including full, limited, and none, as a means to provided restrictions to modification (i.e. a user modifying operational data set by an HCP see para. 0053) it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to add a limited access setting to the device of Tanenbaum, thus giving Tanenbaum a full, limited, and no access hierarchy.
As such Tanenbaum would be able to determine control privileges based on the permissions given to the operator (read/write, limited read/write, or read only. As detailed in para. 0053 of Reggiardo, the first access level allows for setting or locking configurations of the device, and thus it is interpreted that such access level would configure the device based on control input corresponding to a control privilege.
In view of the amendments filed 02/17/2026, the examiner notes that although Tanenbaum discloses patient identifying information (para. 00345 patient related data), and further discloses medical treatment data, Tanenbaum does not disclose that said information is de-identified.
Hanina teaches a medical control computer program and is thus considered analogous to the claimed invention. Hanina teaches that it is possible to blue or otherwise de-identify patient information from a system, such as prescription information noted (para. 0077), where said de-identification can be performed locally. Therefore. As Tanenbaum discloses that medical treatment data (which is interpreted to include an operating prescription) and Hanina teaches that prescriptions or other patient identifying information is known to be de-identified locally, it would have been obvious to on having ordinary skill in the art prior to the effective filing date of the claimed invention to de-identify the medical treatment data of Tanenbaum, as de-identifying patient data is a known technique used in the art for privacy, and applying the technique of Hanina in the same manner to the system of Tanenbaum would achieve predictable results, namely the hiding or obscuring of private health data. The examiner notes that as detailed under the response to arguments, Hanina (para. 0077) teaches that the device may blur or otherwise de-identify patient information and thus reads to the claimed limitation.
Regarding claim 23, Tanenbaum, Reggiardo, and Hanina teach
The dialysis system of claim 1, wherein the access rights associated with the first credential used by the first remote user device are based on a contractual relationship, a fiduciary relationship, and/or a duty of care for the patient. The examiner notes that as detailed under the rejection of claim 1, the access rights are associated with HCP, therefore they are based on duty of care relationship.
Regarding claim 26, Tanenbaum, Reggiardo, and Hanina teach
The dialysis system of claim 1, wherein the data types further comprise real-time dialysis treatment data. The examiner notes that as detailed under the rejection of claim 1, Tanenbaum discloses that the sensors provide data, and the controller monitors data compared to limits set, it is interpreted that the data is in real time.
Claim(s) 4,7,8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanenbaum in view of Reggiardo and Hanina, and further in view of Soykan US 2013/0274642, hereafter Soykan.
Regarding claim 4, Tanenbaum, Reggiardo, and Hanina teach
The dialysis system of claim 1, wherein the controller: monitors the at least one sensor to determine a current state of the dialysis treatment session as detailed above under the rejection of claim 1, Tanenbaum discloses the use of sensors to sense system parameters to sense a limit (para. 0045). Tanenbaum further discloses that in response to determining that the current state of the dialysis treatment session comprises at least one fluidics parameter being outside of an acceptable range: associates the control input with a therapeutic response to the at least one fluidics parameter being outside of the acceptable range; and communicates a control recommendation to the first user device in response to determining that the control level associated with the first user device allow selection of the control recommendation (Tanenbaum Fig.9, para. 0007,0045). The examiner notes that the second limit as detailed under paragraph 0007 is interpreted as at least one fluidics parameter being outside an acceptable range. Per paragraph 0037, upon alarm situations, a warning message is displayed for the operator and may prompt the operator for a specific action such as setting treatment parameters. The examiner notes that the alarm regarding a limit reached is interpreted as a control recommendation, as the alarm is based off of sensed parameters and requests the operator to set a treatment parameter prior to or after the alarm limit is reached (See also para. 0049). This insures smoother treatment of the operation of the device (0049). The examiner notes further that as the operator must first confirm their credentials to access the information of the system, it is interpreted that the control level associated with the device allows selection of the control of the system.
However, while Tanenbaum discloses that the system parameters are monitored by the controller, Tanenbaum in combination with Reggiardo fails to specifically disclose that the controller monitors the respective states of the at least one fluidics actuators
Soykan teaches a dialysis system and is thus considered analogous to the claimed invention. Soykan teaches that all pumps and valves of the dialysis system may be under the control of a controller, where the controller can control and monitor a pumping rate between pumps of the system. The controller can further calculate parameters including fluid removed during ultrafiltration to adjust control of the system (Para. 0159). Therefore as Soykan teaches that controllers are used to monitor and control states of pumps within dialysis systems (where as detailed above under the rejection of claim 1 pumps are interpreted as actuators) it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have the controller of Tanenbaum and Reggiardo control the pumps of the system in response to sensed data, where different operational modes are interpreted as different pump states.
Regarding claim 7, Tanenbaum, Reggiardo, Hanina, and Soykan teach
The dialysis system of claim 4, wherein: the at least one sensor comprises one or more of: (i) a blood pressure sensor configured to measure the at least one fluidics parameter comprising blood pressure of the patient(Tanenbaum Para. 0044). The combination as provided under the rejection of claim 4 fail to specifically teach that the at least one dialysis actuator comprises a dialysate pump positioned to move dialysate through the dialyzer at a dialysate flow rate and a prescription comprises at least one of a fluid removal rate goal and a fluid removal amount goal that is related to a pump rate of the dialysate pump and related to a duration of the dialysis treatment session; and the controller adjusts the pump rate of the dialysate pump and correspondingly adjusts at least one of the fluid removal rate goal and the fluid removal amount goal to cause an adjustment of the at least one parameter toward the acceptable range.
Soykan however teaches that dialysate is directed through the system using pumps (Para. 0151), where said pumps may be controllable by a controller (para. 0159). Soykan further teaches that figure 32 shows a method of maintaining or returning a system parameter at or to a desired range (Para. 0295), where said desired range is interpreted as a prescription. Further, per paragraph 0300, Soykan teaches a method per figure 34, where said method allows the system to monitor parameters to determine if said parameters are within a first or second range, and thus functioning as intended (para. 0300). Per paragraph 0300, Soykan further teaches that when functioning the method determines whether or not effective therapy is being delivered through monitoring of goals, including (slow) rate of waste or fluid removal, and whether or not the operation of the system may be need to be adjusted, such as extended operation to meet said therapeutic goals. Said goals (slow rate or fluid removal) and are thus interpreted as a fluid removal rate goal and fluid removal amount goal, respectively. Therefore it is interpreted that Soykan teaches the controlling of a dialysate pump via a controller, where treatment occurs to achieve desired (prescribed) values of parameters and to meet operational goals, and where said goals include slow rate of waste and fluid removal, and where said parameters and goals are continuously checked to be functioning as desired. Therefore it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to set operational goals to be monitored by the system of Tanenbaum, Reggiardo, and Soykan, as doing so would allow for the controller to determine if a change or extension in operation is needed, to help facilitate patient treatment.
Regarding claim 8, Tanenbaum, Reggiardo, Hanina, and Soykan teach
The dialysis system of claim 4, wherein the controller: transmits a report to the first user device indicating successful configuration of the fluidics system in response to the control input being both allowed therapeutically and according to control level; and transmits a report to the first user device indicating unsuccessful configuration of the fluidics system in response to the control input being one or more of not allowed therapeutically or not allowed according to the control level of control privileges associated with the first credential (Tanenbaum Fig.5, para. 0037). The examiner notes that per paragraph 0037, status box (518, Fig. 5) appears in the left corner of the display screen and displays the operation mode of the machine. When functioning, said box reads dialysis, and is thus interpreted as displaying a successful configuration in response to a user providing appropriate credentials and monitoring and controlling the system (as detailed under the rejection of claim 1). Further upon an alarm system the box will display warning, and as such is interpreted as indicating unsuccessful configuration in response to the control input being not allowed therapeutically due to the suspension of the treatment due to the alarm state (para. 0007).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanenbaum in view of Reggiardo and Hanina, and further in view of Curtis et al. US 2011/0189048, hereafter Curtis.
Regarding claim 3, Tanenbaum, Reggiardo, and Hanina teach
The dialysis system of claim 1, and although the combination of art teach an arterial line (Tanenbaum Fig. 1), the combination fails to specifically teach a venous portion configurable to return treated blood to the patient; a dialysate module comprising the dialyzer that treats the untreated blood; and a water treatment module that provides filtered water to the dialysate module.
Curtis teaches a dialysis system and is thus considered analogous to the claimed invention. Curtis teaches that the system comprises a venous line (Fig. 14, (1410)) for flow to a patient and an arterial line (1415)for flow from a patient (Para. 0059). Curtis further teaches a dialyzer module may be included for performing various blood treatments (Para. 0027, fig. 14 (1425)). Curtis further discloses that in figure 22, a water supply system (2210) may be used with other embodiments of the disclosure (para. 0063). Said water supply system supplies filtered water to a dialysate handling system (2215), where said dialysate handling system further provides dialysate to a dialyzer (para. 0063). Therefore as Curtis teaches that it is known in the art for dialysis systems to comprise venous lines, arterial lines, and dialyzers and that filtered water is commonly used as in dialysate, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide such structures with the dialysis system of Tanenbaum, Reggiardo, and Soykan.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanenbaum in view of Reggiardo, Hanina, and Soykan, and further in view of Curtis.
Regarding claim 5, Tanenbaum, Reggiardo, Hanina, and Soykan teach
The dialysis system of claim 4, and although as detailed under the rejection of claim 1, the controller of Tanenbaum is configured to control operation of the system and receive data from sensors, the combination of art fails to specifically teach wherein the at least one sensor senses the corresponding at least one parameter that is related to blood flow rate; the at least one dialysis actuator comprises a blood pump positioned to move untreated blood of the patient through the dialyzer at a defined blood flow rate; and the controller actuates a pump rate of the blood pump to adjust the blood flow rate toward the acceptable range.
Curtis teaches a dialysis system and is thus considered analogous to the claimed invention. Curtis teaches the use a one or more pumps for driving fluid through the dialysis system, where said pumps may be associated with one or more sensors including flow sensors for reporting one or more characteristics of fluid flowing through the system (para. 0027). Therefore as Curtis teaches the use fluid flow pumps in dialysis systems where said pumps are used in combination with flow sensors, as said sensors measure desired characteristics, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide a flow sensor with the device of Tanenbaum, Reggiardo, and Soykan. The examiner notes that as detailed under the rejection of claim 1, as the controller takes sensed information and indicates to a user to control the operation of the system based on the sensed information to avoid an alarm situation, the controller would receive and input actuate the pump to avoid an alarm flow rate condition.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanenbaum in view of Reggiardo, Hanina, and Soykan, and further in view of Parisotto et al. US 2016/0250406, hereafter Parisotto.
Regarding claim 6, Tanenbaum, Reggiardo, Hanina, and Soykan teach
The dialysis system of claim 4, wherein: the at least one sensor comprises one or more of: (i) a blood pressure sensor configured to measure the at least one fluidics parameter comprising a blood pressure of the patient (Tanenbaum Para. 0044), however fail to teach that the at least one dialysis actuator is configured to selectively allow at least one of: (i) a saline bolus; and (ii) an ultrapure dialysate to be infused with the blood of the patient; the at least one fluidics parameter is based on at least one of an arterial pressure value detected by an arterial pressure sensor and a venous pressure value detected by a venous pressure sensor; and the controller actuates the at least one dialysis actuator to infuse the at least one of: (i) a saline bolus; and (ii) the ultrapure dialysate to adjust the at least one fluidics parameter toward the acceptable range.
Parisotto teaches a blood treatment apparatus and its control and is thus considered analogous to the claimed invention. Parisotto teaches the use of a vent valve, where said vent valve is connected to a venous pressure sensor, and where said vent valve is opened to suck or aspirate dialysis fluid over or through the membrane and out through the blood tube set (para. 0023-0027). Per paragraph 0076, Parisotto teaches that any of the method steps may be programmed or controlled to be carried out. Further per paragraph 0007, the method steps are carried out until conditions such as when the sensor detects air or clots. Therefore as Parisotto teaches the use of a programed valve associated to open in with connection to a venous pressure sensor and transducer until a fault is detected, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the combination of Tanenbaum, Reggiardo, and Soykan with a controllable valve to move dialysate across the dialyzer, and modify the system based on sensed data from a venous pressure sensor.
Claim(s) 29,30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanenbaum in view of Reggiardo.
Regarding claim 29, Tanenbaum discloses
A dialysis system (Fig. 1, para. 0020) comprising: a fluidics system configured to perform a dialysis treatment session for a patient (Fig. 1 tubing (8)), the fluidics system comprising: at least one sensor that senses a corresponding at least one parameter (Para. 0044); a dialyzer (Para. 0002; the examiner notes that per this citation of Tanenbaum, a dialysis system, including a dialyzer, is disclosed in which the monitoring system of Tanenbaum is used with); and at least one dialysis actuator that configures fluid flow through the fluidics system (Para. 0002; the examiner notes that per this citation of Tanenbaum, a dialysis system, including an actuator (blood is pumped through the system), is disclosed in which the monitoring system of Tanenbaum is used with) a communication subsystem configured to communicatively connect to one or more user devices (Fig. 1, transceiver (40), Fig. 3). The examiner notes that per paragraph 0025, figure 3 depicts a user interface processing device (UIP) is shown to be combined with a dialysis system, where said UIP may include a variety of interface devices such as tablets or smart phones (para. 0026) interpreted to connect with the transceiver depicted in figures 1 and 2.
Tanenbaum further discloses a controller communicatively coupled to the fluidics system and the communication subsystem (Fig. 1, controller (30)) and which: operates the fluidics system to perform the dialysis treatment session (Para. 0021); identifies access rights associated with a first credential used by a first user device to one or more of the data types (Para. 0009,0042); communicates one or more of the data types to the first user device according to the access rights (Para. 0009,0042). The examiner notes that per paragraphs 0009 and 0042, the data stored by the system may be encrypted and may require a health care practitioner (HCP) or user to login in to access the data using authorized credentials. The examiner notes that the data is available, but some of it is encrypted. Therefore prior to entering a password to access the encrypted data, the access is limited to a subset of data (only can see the non-encrypted data). When the password is entered, the encrypted data is revealed, thus the user has access to all of the data.
Tanenbaum further discloses that a control input comprising at least a portion of a prescription attributed to a patient identifier(para. 0047). Per paragraph 0047, soft thresholds/limits are set on the remote device, where said limits are treatment parameters based on patient related variables, such as blood pressure, heart rate, or other monitored blood parameter levels. The examiner notes that as a user inputs a limit (control) comprising patient related variable to aid in the monitoring of the operation of the treatment, it is interpreted that Tanenbaum discloses a control input (setting of the limit) comprising at least a portion of a prescription (treatment limits) attributed to a patient identifier (patient related variables). See also paragraph 0008 and 0009, where the first limit is a treatment parameter.
Tanenbaum further discloses that in response to receiving a control input from the first user device: identifies a control level of control privileges associated with the first credential used by the first user device to reconfigure the fluidics system to change the dialysis treatment session (Para. 0009, 0042); monitors the at least one sensor and respective states of the at least one fluidics actuators to determine a current state of the dialysis treatment session (Fig. 9, para. 0045, where soft limits are set and monitored by the controller to give an alarm when said limit is reached, where said limit is a measured treatment parameter per para. 0008)); determines whether the control input is therapeutically allowed based on the current status of the dialysis treatment session (Para. 0045); determines whether the first user device has the corresponding control level associated with the control input (Para. 0045); and configures the fluidics system in response to the control input being both allowed therapeutically and according to the corresponding control level (Para. 0004, 0021 0043). The examiner notes that per paragraphs 0021 and 0043, the controller may be used to control the operation of the dialysis, where a HCP accesses the interface via entering credentials and monitors the system. The HCP may enter a control input to adjust the system as required (para. 0021). Further per para. 0045, and as seen in figure 9, “soft limits” may be set and the system may operate as normal (monitored by HCP) until said limits are reached, at which point the operation of the system may be changed. Therefore, as a HCP needs access credentials to log in to the interface to monitor and control the operation of the dialysis system, it is interpreted that the controller determines if control input is therapeutically allowed via said soft limiters, determines the corresponding control level via the HCP login access, and configures the system in response received by a verified HCP and in response to said limiters.
Further Tanenbaum discloses determines whether the control input is therapeutically allowed based on the current status of the dialysis treatment session, wherein a control input is therapeutically allowed if the control input falls within an acceptable range previously determined to not injure the patient or damage the fluidics system; and configures the fluidics system in response to the control input being allowed therapeutically (para. 0008,0048). Per para. 0008, 0048, “hard limits” are disclosed to be set in addition to the soft limits set on the mobile device. The hard limits is set at the machine correspond regulations and guidelines of the machine (para. 0008,0048), where when the hard limit is reached the machine suspends operation of the machine. Therefore it is interpreted that any input that falls below the hard limit is an acceptable range, so any treatment input entered of the remote device should be allowed if it is less than the hard limit. The examiner notes that as the hard limit directly correlates to guidelines of operation and the machine shuts down if said limits are reached, it is interpreted that operation past said guidelines is dangerous to the machine and/or patient. Per para. 0048 and 0060 of Tanenbaum, the soft limits are implemented such that the HCP can be warned of conditions that may reach the hard limit. When a hard limit is reached, the system suspends operation (para. 0060). Therefore as the HCP can take action to prevent a hard limit being reached (para. 0060, 0061), but once a hard limit is reached the operation is suspended, the hard limit, where said limits are patient variables (para. 0006) sensed by sensors (para. 0044), it interpreted to be a sensor parameter that associates control privileges with a first credential in that, control under normal operation (under the hard limit of the prior art, or therapeutically allowed as written in the claim) is controlled by an HCP, where once the sensors sense values that are past a limit (or not therapeutically allowed) control is revoked. Thus the operation of the system is based off of sensed data where control is allowed when the sensed data is “good” (or therapeutically allowed) and control is prevented when the data is “bad” (not therapeutically allowed).
Further, Tanenbaum does not specifically disclose that the control privileges being stratified in control levels of: (i) no control allowed; (ii) limited control; and (iii) full control, as Tanenbaum discloses a user login access, where said access is interpreted as having two states, denied (no control) or allowed (full control).
Reggiardo teaches the monitoring of medical infusion devices and is thus considered analogous to the claimed invention. Reggiardo teaches that medical devices as detailed within include a supervisor-controllable and user-restrictive system, where configurations of the devices may be settable by a supervisor (Para. 0053). The modifications relate to data stored on the machine for operation, where Reggiardo teaches that three permission types are created, full access such as full read/write permission (HCP), limited read/write permission (caregiver), and further limited, including no rights to modify (user). Therefore as Reggiardo teaches the use of multiple levels of operational data control in medical devices including full, limited, and none, as a means to provided restrictions to modification (i.e. a user modifying operational data set by an HCP see para. 0053) it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to add a limited access setting to the device of Tanenbaum, thus giving Tanenbaum a full, limited, and no access hierarchy.
As such Tanenbaum would be able to determine control privileges based on the permissions given to the operator (read/write, limited read/write, or read only. As detailed in para. 0053 of Reggiardo, the first access level allows for setting or locking configurations of the device, and thus it is interpreted that such access level would configure the device based on control input corresponding to a control privilege.
Regarding claim 30, Tanenbaum and Reggiardo teach, the dialysis system of claim 29, wherein the controller is further configured to associate control privileges with the first credential based on a predetermined treatment schedule. The examiner notes that per Tanenbaum para.0039, a predetermined operation time is provided in the form of a RTD (remaining time of dialysis button). The treatment time of dialysis is interpreted as a predetermined treatment schedule. The examiner notes that as previously detailed under the rejection of claim 29, the device of Tanenbaum and Reggiardo determines the control privileges of the system prior to operation as the data (including the setting of soft limits (para. 0008) is required to accessed and controlled via providing authorized credentials prior to use. As such it is interpreted that controller associates control privileges based on a predetermined treatment schedule (when patient is required for treatment and then when treatment begins and the HCP logins in to access the data).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanenbaum in view of Reggiardo and further in view of Ballantyne et al. US 2016/0058933, hereafter Ballantyne.
Regarding claim 31, Tanenbaum and Reggiardo teach the dialysis system of claim 29, but fails to teach wherein the subset of controls level of the control privileges comprises: (i) therapeutically allowed controls (as detailed above under the rejection of claim 1, where the soft limit and adjustments are allowed until a hard limit is reached); but fails to teach wherein the subset of controls level of the control privileges comprises: (ii) maintenance actions permitted only while the session is not operated.
Ballantyne teaches a control system for medical devices and is thus considered analogous to the claimed invention. Ballantyne teaches that in operation, in response to data received from the system, command the user interface controller to issue a message to the user interface, receive input from the user interface controller in response to input from the user interface, and suspend or terminate a therapy of the hemodialysis apparatus, or prevent a future therapy of the hemodialysis apparatus until a repair or maintenance procedure has been performed (para. 0018). Therefore as Ballantyne teaches that upon receiving maintenance/repair notifications, the system is shut down from use to repair the device, it is interpreted that maintenance/repair operations/procedures would be done only while the system is not in session. As such, as a means to safely operate the system, it would have been obvious to one having ordinary skill in the art prior to the effective filling date of the claimed invention to, upon receiving a maintenance requirement, shut down the system of Reggiardo until a maintenance procedure/operation is performed. As such the system would include a control of maintenance operations, where said operations would only be performed while the system is off.
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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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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