DETAILED ACTION
Notice to Applicant
This communication is in response to the amendment submitted February 26, 2025. The present application is a U.S. National Stage of PCT International Patent Application No. PCT/EP2019/085155, filed December 13, 2019, which claims priority to EP Application No. 19305268.5, filed March 8, 2019. Claims 1, 15, and 20 are amended. Claim 3 is cancelled. Claims 1 – 2 and 4 – 20 are pending.
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 § 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 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.
Claim(s) 1 – 2, 4 – 10 and 13 – 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belkin et al., herein after Belkin (U.S. Publication Number 2017/0319780 A1) in view of Hickle et al., herein after Hickle (WO 03/072184 A2) further in view of Moosmann et al., herein after Moosmann (U.S. Patent Number 8,910,131 B2).
Claim 1 (Currently Amended): Belkin teaches a medical device comprising:
a control device for controlling operation of the medical device (Figure 5; paragraph 8 discloses a user interface controller), the control device comprising a first processing unit for controlling a first function of the medical device (paragraph 9 discloses the user interface controller includes at least a first processor) and a second processing unit for controlling a second function of the medical device (paragraph 9 discloses the pump motor controller includes a second processor), the second function being different from the first function (paragraph 9 discloses a user interface controller (UIC) which is interpreted as the first function (a first processor and first memory, and displays infusion status), and a second function (a pump motor controller (PMC) which includes a second processor, a second memory, and a pump controller which delivers a fluid, including one or more drugs) indicating differences between the first function and second function);
Concurrently [monitoring] each of the first processing unit with the second processing unit (paragraph 8 discloses the drug infusion system includes distributed components that include a user interface controller (UIC) generally having complex business logic and complex user interface functionality, and at least one pump motor controller (PMC) acting as a real-time controller, wherein the UIC and PMC communicate over a communication link; paragraph 12 discloses the UIC may pass the token to the PMC to initiate drug infusion, the PMC then runs the infusion therapy and monitors communication with the UIC, and while running the program, the PMC updates the UIC with an infusion status update message; paragraph 24 discloses UIC may control more than one PMC, indicating a first processing unit (UIC), and more than one processing units (PMC) controlling the pump motor(s)).
Belkin fails to explicitly teach the following limitations met by Hickle as cited:
wherein the control device comprises a failsafe state machine (paragraph 9 discloses a fail-safe module (FSM)) configured to monitor a first operational status (paragraph 9 discloses the FSM may deactivate sedation and analgesia delivery to ensure patient safety) and a second operational status of the second processing unit (paragraph 9 discloses the FSM may deactivate specific patient interfaces and/or user interfaces to ensure patient safety) and to control a state of the medical device dependent on the first operational status and the second operational status (paragraph 29 discloses converting sedation and analgesia system into a safe state mode to reduce potential harm caused by drug delivery, patient interface, or other critical peripherals that may include malfunctioning hardware or software).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Belkin to further include fail-safe modules integral with sedation and analgesia systems that powers down the sedation and analgesia system in the event of a detected malfunction as disclosed by Hickle.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of Belkin in this way to provide a fail-safe module (FSM) integral with a sedation and analgesia system that meets the high-reliability needs of sedition and/or analgesia delivered by non-anesthetists in order to ensure optimal patient safety (Hickle: paragraph 9).
Belkin and Hickle fail to explicitly teach the following limitations met by Moosmann as cited:
wherein the failsafe state machine is embodied by a programmable component separate to the first processing unit and the second processing unit (column 4, lines 34 – 42 discloses the computer executes a computer program. The computer program allows a user program to be written for a safety controller; column 4, lines 50 – 61 discloses a first processor and a second processor separate from each other. The two processors are in contact with one another via a bidirectional communication interface in order to be able to monitor one another and interchange data. The two channels of the safety controller and the two processors are different from one another, in order to largely preclude systematic errors), and
wherein the medical device comprises an individual chip for each of the failsafe state machine, the first processing unit, and the second processing unit (column 5, lines 4 – 12 discloses the program memory is in the form of a chip card, this allows simple interchange of the machine code and hence the user program even without direct connection to the computer. Alternatively, the program memory may also be in the form of a memory which is permanently installed in the safety controller, for example an EEPROM).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Belkin and Hickle to further include a method and apparatus for generating a user program for a safety controller which is designed to control an automated installation having a plurality of sensors and a plurality of actuators as disclosed by Moosmann.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of Belkin and Hickle in this way to provide a method and apparatus to further increase the flexibility for the generating of a user program to allow faster and less expensive programming of a safety controller (Moosmann: column 2, lines 44 – 49).
Claim 2 (Previously Presented): Belkin, Hickle, and Moosmann teach the medical device according to claim 1. Belkin teaches wherein the first processing unit and the second processing unit are embodied by individual processors (paragraph 25 discloses a communication link established between the first processor and second processor, indicating individual processors).
Claim 4 (Previously Presented): Belkin, Hickle, and Moosmann teach the medical device according to claim 3. Belkin teaches wherein the failsafe state machine is embodied by a Complex Programmable Logical Device (CPLD) or Filed Programmable Gate Array (FPGA) (paragraph 8 discloses complex business logic).
Claim 5 (Previously Presented): Belkin, Hickle, and Moosmann teach the medical device according to claim 1.
Belkin failHHs to explicitly teach the following limitations met by Hickle as cited:
wherein the first processing unit is configured to control operation of at least one of a sensor device and an actor device for performing a mechanical function (paragraph 20 discloses data and/or commands may be outputted from controller in the form of output to peripherals associated with sedation and analgesia system, fail-safe module, and patient interface).
The motivation to combine the teachings of Belkin and Hickle is discussed in the rejection of claim 1, and incorporated herein.
Claim 6 (Previously Presented): Belkin, Hickle, and Moosmann teach the medical device according to claim 5. Belkin teaches wherein the actor device is part of a pumping mechanism for administering a medical fluid to a patient (paragraph 26 discloses the second processor may transfer the first delivery request from the second processor drug infusion service queue to the second processor drug infusion working queue, and may command the pump motor to deliver the fluid).
Claim 7 (Previously Presented): Belkin, Hickle, and Moosmann teach the medical device according to claim 1.
Belkin fails to explicitly teach the following limitations met by Hickle as cited:
wherein the second processing unit is configured to control operation of at least one software application of the medical device (paragraph 43 discloses a health check system which polls each compartmentalized software module and verifies that each one indicates that it is operating properly, the health check system is software based and the fail-safe module is implemented via hardware such as a complex programmable logic device (CPLD)).
The motivation to combine the teachings of Belkin and Hickle is discussed in the rejection of claim 1, and incorporated herein.
Claim 8 (Previously Presented): Belkin, Hickle, and Moosmann teach the medical device according to claim 1.
Belkin fails to explicitly teach the following limitations met by Hickle as cited:
wherein at least one of the first processing unit and the second processing unit comprise a watchdog device for monitoring a state of the associated processing unit, wherein the failsafe state machine is configured, for monitoring the operational status of the associated processing unit, to monitor a signal of the watchdog device (paragraph 8 discloses the need for a watchdog system; paragraph 21 discloses the fail-safe module must receive the strobe initiated by the controller within a predetermined time window in order to maintain sedation and analgesia system in an operation state mode, the failure of the controller to initiate and deliver the strobe within the specified window indicates to fail-safe module that an anomaly has occurred in the health check system or in the program modules associated with sedation and analgesia system resulting int the fail-safe module transferring the sedation and analgesia system into safe state mode).
The motivation to combine the teachings of Belkin and Hickle is discussed in the rejection of claim 1, and incorporated herein.
Claim 9 (Previously Presented): Belkin, Hickle, and Moosmann teach the medical device according to claim 1. Belkin teaches wherein the failsafe state machine, for controlling a state of the medical device, is configured to at least one of reset the first processing unit, reset the second processing unit, trigger an alarm, switch off an actor device, switch off a human machine interface, switch off a communication interface, and enable a switching off of the medical device (paragraph 39 discloses the timeout timers in the UIC and PMC may be reset in software, or may be automatically reset if implemented in hardware, as well as disclosing an emergency stop signal to stop the PMC from pumping).
Claim 10 (Previously Presented): Belkin, Hickle, and Moosmann teach the medical device according to claim 1. Belkin teaches wherein the failsafe state machine is configured to provide a status signal to at least one of the first processing unit and the second processing unit to indicate a functional status of the failsafe state machine to the at least one of the first processing unit and the second processing unit (paragraph 12 discloses the PMC updates the UIC with an infusion status update message, which may contain the currently executing program and associated program steps, the infusion related options, and current state; paragraph 13 discloses if the UIC fails the PMC takes control of the alarm components and signals the failure to the user, on a limited display local to the PMC, or alternatively using operable portions of the UIC related display, and the PMC may display infusion progress and status).
Claim 13 (Previously Presented): Belkin, Hickle, and Moosmann teach the medical device according to claim 1.
Belkin fails to explicitly teach the following limitations met by Hickle as cited:
wherein at least one of the first processing unit and the second processing unit is configured to activate or deactivate the failsafe state machine (paragraph 29 discloses converting sedation and analgesia system into a safe state mode to reduce potential harm caused by drug delivery, patient interface, or other critical peripherals that may include malfunctioning hardware or software).
The motivation to combine the teachings of Belkin and HHHickle is discussed in the rejection of claim 1, and incorporated herein.
Claim 14 (Previously Presented): Belkin, Hickle, and Moosmann teach the medical device according to claim 13.
Belkin fails to explicitly teach the following limitations met by Hickle as cited:
wherein during a start-up phase of the medical device the failsafe state machine is disabled, until the failsafe state machine is activated by the at least one of the first processing unit and the second processing unit (paragraph 29 discloses converting sedation and analgesia system into a safe state mode to reduce potential harm caused by drug delivery, patient interface, or other critical peripherals that may include malfunctioning hardware or software).
The motivation to combine the teachings of Belkin and Hickle is discussed in the rejection of claim 1, and incorporated herein.
Claim 15 (Currently Amended): Belkin teaches a method for operating a medical device, comprising:
controlling, using a control device, operation of the medical device (Figure 5; paragraph 8 discloses a user interface controller), the control device comprising a first processing unit for controlling a first function of the medical device (paragraph 9 discloses the user interface controller includes at least a first processor) and a second processing unit for controlling a second function of the medical device (paragraph 9 discloses the pump motor controller includes a second processor), , the second function being different from the first function (paragraph 9 discloses a user interface controller (UIC) which is interpreted as the first function (a first processor and first memory, and displays infusion status), and a second function (a pump motor controller (PMC) which includes a second processor, a second memory, and a pump controller which delivers a fluid, including one or more drugs) indicating differences between the first function and second function);
Concurrently [monitoring] each of the first processing unit with the second processing unit (paragraph 8 discloses the drug infusion system includes distributed components that include a user interface controller (UIC) generally having complex business logic and complex user interface functionality, and at least one pump motor controller (PMC) acting as a real-time controller, wherein the UIC and PMC communicate over a communication link; paragraph 24 discloses UIC may control more than one PMC, indicating a first processing unit (UIC), and more than one processing units (PMC) controlling the pump motor(s)).
Belkin fails to explicitly teach the following limitations met by Hickle as cited:
Monitoring, using a failsafe state machine of the control device (paragraph 9 discloses a fail-safe module (FSM)), a first operational status (paragraph 9 discloses the FSM may deactivate sedation and analgesia delivery to ensure patient safety) and a second operational status of the second processing unit (paragraph 9 discloses the FSM may deactivate specific patient interfaces and/or user interfaces to ensure patient safety) and controlling a state of the medical device dependent on the first operational status and the second operational status (paragraph 29 discloses converting sedation and analgesia system into a safe state mode to reduce potential harm caused by drug delivery, patient interface, or other critical peripherals that may include malfunctioning hardware or software),
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Belkin to further include fail-safe modules integral with sedation and analgesia systems that powers down the sedation and analgesia system in the event of a detected malfunction as disclosed by Hickle.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of Belkin in this way to provide a fail-safe module (FSM) integral with a sedation and analgesia system that meets the high-reliability needs of sedition and/or analgesia delivered by non-anesthetists in order to ensure optimal patient safety (Hickle: paragraph 9).
Belkin and Hickle fail to explicitly teach the following limitations met by Moosmann as cited:
wherein the failsafe state machine is embodied by a programmable component separate to the first processing unit and the second processing unit (column 4, lines 34 – 42 discloses the computer executes a computer program. The computer program allows a user program to be written for a safety controller; column 4, lines 50 – 61 discloses a first processor and a second processor separate from each other. The two processors are in contact with one another via a bidirectional communication interface in order to be able to monitor one another and interchange data. The two channels of the safety controller and the two processors are different from one another, in order to largely preclude systematic errors), and
wherein the medical device comprises an individual chip for each of the failsafe state machine, the first processing unit, and the second processing unit (column 5, lines 4 – 12 discloses the program memory is in the form of a chip card, this allows simple interchange of the machine code and hence the user program even without direct connection to the computer. Alternatively, the program memory may also be in the form of a memory which is permanently installed in the safety controller, for example an EEPROM).
The motivation to combine the teachings of Belkin, Hickle, and Moosmann is discussed in the rejection of claim 1, and incorporated herein.
Claim(s) 16 – 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belkin et al., herein after Belkin (U.S. Publication Number 2017/0319780 A1) in view of Hickle et al., herein after Hickle (WO 03/072184 A2) in view of Moosmann et al., herein after Moosmann (U.S. Patent Number 8,910,131 B2) further in view of Merkel et al., herein after Merkel (U.S. Patent Number 11,670,414 B2).
Claim 16 (Previously Presented). Belkin, Hickle, and Moosmann teach the method according to claim 15.
Belkin, Hickle, and Moosmann fail to explicitly teach the following limitations met by Merkel as cited:
wherein controlling, using the control device, operation of the medical device includes controlling, using the first processing device, at least one of a sensor device and an actor device for performing a mechanical function (column 4, lines 31 – 46 discloses by carrying out the steps simultaneously, it can be ensured that all the incorrect functional states occurring will be detected rapidly, the individual steps are carried out in relation to a cycle of the processor cores of the standard computer and of the control device simultaneously or continuously; column 9, lines 7 – 29 disclose simultaneously, the standard computer and the control device always mutually monitor each other and themselves concerning the presence of an incorrect functional status).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Belkin, Hickle, and Moosmann to further include providing a failure safety for a medical monitoring procedure of patient data including wherein the medical monitoring procedure is carried out by a standard computer as disclosed by Merkel.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of Belkin, Hickle, and Moosmann in this way to provide failure safety for a medical monitoring procedure, by which the highest possible safety can be made available for a patient being monitored, wherein especially a failure of components of the standard computer or of the entire monitoring procedure can be detected with certainty and displayed to a user by an alarm (Merkel: column 2, lines 3 – 11).
Claim 17 (Previously Presented). Belkin, Hickle, Moosmann, and Merkel teach the method according to claim 16. Belkin discloses a method wherein the actor device performing the mechanical function comprises administering a medical fluid to the patient (Figure 3 discloses delivering programmed infusion; paragraph 9 discloses a pump motor to deliver a fluid, for example one or more drugs; paragraph 24 discloses a drug infusion therapy system).
Claim 18 (Previously Presented). Belkin, Hickle, and Moosmann teach the medical device according to claim 1.
Belkin, Hickle, and Moosmann fail to explicitly teach the following limitations met by Merkel as cited:
wherein the failsafe state machine being configured to monitor concurrently each of the first processing unit with the first operational status and the second processing unit with the second operational status comprises being configured to monitor in parallel and at the same time (column 4, lines 31 – 46 discloses by carrying out the steps simultaneously, it can be ensured that all the incorrect functional states occurring will be detected rapidly, the individual steps are carried out in relation to a cycle of the processor cores of the standard computer and of the control device simultaneously or continuously; column 9, lines 7 – 29 disclose simultaneously, the standard computer and the control device always mutually monitor each other and themselves concerning the presence of an incorrect functional status).
The motivation to combine the teachings of Belkin, Hickle, Moosmann, and Merkel is discussed in the rejection of claim 16, and incorporated herein.
Claim 19 (Previously Presented). Belkin, Hickle, Moosmann, and Merkel teach the method according to claim 15.
Belkin, Hickle, and Moosmann fail to explicitly teach the following limitations met by Merkel as cited:
wherein monitoring concurrently comprises monitoring in parallel and at the same time (column 4, lines 31 – 46 discloses by carrying out the steps simultaneously, it can be ensured that all the incorrect functional states occurring will be detected rapidly, the individual steps are carried out in relation to a cycle of the processor cores of the standard computer and of the control device simultaneously or continuously; column 9, lines 7 – 29 disclose simultaneously, the standard computer and the control device always mutually monitor each other and themselves concerning the presence of an incorrect functional status).
The motivation to combine the teachings of Belkin, Hickle, Moosmann, and Merkel is discussed in the rejection of claim 16, and incorporated herein.
Claim(s) 11 – 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belkin et al., herein after Belkin (U.S. Publication Number 2017/0319780 A1) in view of Hickle et al., herein after Hickle (WO 03/072184 A2) in view of Moosmann et al., herein after Moosmann (U.S. Patent Number 8,910,131 B2) further in view of Lambertson (U.S. Publication Number 2021/0055336 A1).
Claim 11 (Previously Presented): Belkin, Hickle, and Moosmann teach the medical device according to claim 1.
Belkin, Hickle, and Moosmann fail to explicitly teach the following limitations met by Lambertson as cited:
wherein the failsafe state machine comprises a backup power supply separate from a main power supply of the medical device (paragraph 123 discloses the power supply may be implemented as backup power supply, the main power supply and the backup power supply are separated using a diode).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Belkin, Hickle, and Moosmann to further include a method for determining the system resistance of a handheld device used for detecting at least one analyte present in one or both of a body tissue or a body fluid as disclosed by Lambertson.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of Belkin, Hickle, and Moosmann in this way to allow effective and fast quality control of the power supply of the handheld device by reliably determining undervoltage or battery failure of the power supply of the handheld medical device (Lambertson: paragraph 70).
Claim 12 (Previously Presented): Belkin, Hickle, Moosmann, and Lambertson teach the medical device according to claim 11.
Belkin, Hickle, and Moosmann fail to explicitly teach the following limitations met by Lambertson as cited:
wherein the backup power supply is a capacitor for storing electrical energy (paragraph 26 discloses the power source may comprise at least one power source selected from the group consisting of at least one battery, at least one rechargeable battery, or at least one electric double layer capacitor; paragraph 124 discloses an electronic double layer capacitor may be used as a power backup during a change of battery).
The motivation to combine the teachings of Belkin, Hickle, Moosmann, and Lambertson is discussed in the rejection of claim 11, and incorporated herein.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belkin et al., herein after Belkin (U.S. Publication Number 2017/0319780 A1) in view of Hickle et al., herein after Hickle (WO 03/072184 A2) in view of Moosmann et al., herein after Moosmann (U.S. Patent Number 8,910,131 B2) and Derr et al. (U.S. Publication Number 2019/0050279 A1).
Claim 20 (Currently Amended). Belkin, Hickle, and Moosmann teach the medical device according to claim 1.
Belkin, Hickle, and Moosmann fail to explicitly teach the following limitations met by Derr as cited:
wherein the medical device comprises a common circuit board, and the failsafe state machine, the first processing unit, and the second processing unit each comprise an individual chip on the common circuit board (paragraph 28 discloses a microprocessor chip domain which interfaces with memory; paragraph 29 discloses a companion chip domain which provides support interfaces for peripheral devices; paragraph 30 discloses the microprocessor chip domain and companion chip domain may be integrated as separate chips or on a single chip with integrated controllers).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Belkin, Hickle, and Moosmann to further include functional safety error reporting and handling infrastructure which include a common error handler that handles errors for a plurality of hardware devices, where the common error handler may be used to receive an error message from a hardware device, the error message related to an error; identify a source of the error message; identify a class of the error; identify an error definition of the error; determine whether the error requires a diagnostics operation as part of the error handling; initiate the diagnostics operation when the error requires the diagnostics operation; and clear the error at the hardware device as disclosed by Derr.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of Belkin, Hickle, and Moosmann in this way to allow a system to operate correctly and perform appropriately in response to system failures or operator errors in mission critical systems to monitor and report errors so that corrective action may be performed (Derr: paragraph 2).
Response to Arguments
Applicant's arguments filed November 3, 2025 have been fully considered but they are not persuasive. The Applicant’s arguments have been addressed in the order in which they were presented.
The Applicant argues Belkin, Hickle, and Merkel fail to recite the failsafe state machine is configured to monitor concurrently each of the first processing unit and a second processing unit. The Examiner respectfully submits Belkin discloses a user interface controller (UIC) which is interpreted as the first function (a first processor and first memory, and displays infusion status), and a second function (a pump motor controller (PMC) which includes a second processor, a second memory, and a pump controller which delivers a fluid, including one or more drugs) indicating differences between the first function and second function (paragraph 9 of the published specification). The Applicant is arguing the monitoring of a first processing unit and the monitoring of a second processing unit are integral/separable. However, the MPEP in 2144.04, Part V (B. Making Integral and C. Making Separable) provides legal precedent that such aspects of the claimed invention could be considered as matters of obvious engineering or design choice. Thus, Applicant’s argument is not persuasive and the rejection is maintained.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINE K RAPILLO whose telephone number is (571)270-3325. The examiner can normally be reached Monday - Friday 7:30 - 4 pm.
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/K.K.R/Examiner, Art Unit 3682
/ROBERT A SOREY/Primary Examiner, Art Unit 3682