Prosecution Insights
Last updated: April 19, 2026
Application No. 18/629,533

DETECTION OF AUDIBLE ALERTS

Final Rejection §103§DP
Filed
Apr 08, 2024
Examiner
AFRIFA-KYEI, ANTHONY D
Art Unit
2686
Tech Center
2600 — Communications
Assignee
Medtronic Minimed, Inc.
OA Round
2 (Final)
65%
Grant Probability
Moderate
3-4
OA Rounds
3y 0m
To Grant
78%
With Interview

Examiner Intelligence

Grants 65% of resolved cases
65%
Career Allow Rate
353 granted / 546 resolved
+2.7% vs TC avg
Moderate +14% lift
Without
With
+13.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
39 currently pending
Career history
585
Total Applications
across all art units

Statute-Specific Performance

§101
3.4%
-36.6% vs TC avg
§103
71.3%
+31.3% vs TC avg
§102
11.9%
-28.1% vs TC avg
§112
8.4%
-31.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 546 resolved cases

Office Action

§103 §DP
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 . 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. Status of Claims In the amendment filed on December 10th, 2025, no claims have been amended, no claim has been cancelled and no new claim has been added. Therefore, claims 1-20 are pending for examination. Terminal Disclaimer The Terminal Disclaimer filed on 12/20/2025 has been approved. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. Claim(s) 1, 2, 6, 9, 11, 12, 16 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wyeth et al (WO 2021108214 A1) in view of Halbert et al. (US 20150054651 A1). In regards to claim 1, Wyeth on the other hand teaches a method comprising: determining, by one or more processors of a medical device, an occurrence of an alert condition (Paragraphs 55) Implementations may include one or more of the following features. The system where: the user interface is configured to generate a time indication in relation to the audio signal, the time signal indicating a time of the output on the audio output device, and the patient control processor is configured to output an error signal if the time indication is not contemporaneous with the audio output from said audio output device within a predefined range of time. The audio output device includes a speaker. The pattern includes an audio sound power. The if the time indication is not contemporaneous with the audio output from said audio output device within said predefined range of time, then the patient control processor prevents use of a treatment machine. If the patient control processor detects an alarm condition during a treatment, it outputs an alarm signal to the user interface control processor for output to a speaker. If the time indication is not contemporaneous with the audio output from said audio output device within said predefined range of time, then the patient control processor outputs a data maintenance instruction to the user interface control processor to be output on a display. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium. [P-55] Wyeth then teaches causing transmission, via a wireless communication channel and to a physically separate device, data indicative of the occurrence of the alert condition. After causing transmission of the data indicative of the occurrence of the alert condition (Paragraphs 25, 26, 59) Bus 146 may further allow for communication between computer 142 and a display 150, a keyboard 152, a mouse 154, a speaker 156, a microphone 158, and a camera 160 each providing respective functionality in accordance with various embodiments disclosed herein, for example, for configuring a treatment for the patient 122 and monitoring the patient 122 during that treatment. [P-25] Computer 142 may also implement a communication interface 162 to communicate with a network 164 to provide any functionality disclosed herein, for example, for notifying an operator (i.e., healthcare professional) of a treatment alarm and/or receiving instructions from the healthcare professional, reporting patient/device conditions in a distributed system for training a machine learning algorithm, logging data to a remote repository, etc. Communication interface 162 may be any such interface known in the art to provide wireless and/or wired communication, such as a network card or a modem.[P-26] Implementations may include one or more of the following features. The method where: using the processor, generating a time indication in relation to the audio signal, the time signal indicating a time of the output on the audio output device, and the patient control processor is configured to output an error signal if the time indication is not contemporaneous with the audio output from said audio output device within a predefined range of time, the audio output device includes a speaker, the pattern includes an audio sound power. If the patient control processor detects an alarm condition during a treatment, it outputs an alarm signal to the user interface control processor for output to a speaker. The if the time indication is not contemporaneous with the audio output from said audio output device within said predefined range of time, then, using the patient control processor, preventing a use of a treatment machine. The if the time indication is not contemporaneous with the audio output from said audio output device within said predefined range of time, then, using patient control processor outputting a data maintenance instruction to the processor to be output on a display. The pattern includes a time or frequency pattern with a range of frequencies with a distinctive audio signature. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium. [P-59] Here causing transmission, via a wireless communication channel or network and to a physically separate device such as a speaker, data indicative of the occurrence of the alert condition. Wyeth then teaches obtaining, using a microphone of the medical device, an audio signal (Paragraphs 47) The test pattern is applied to a user interface controller 302 which converts the test pattern S220 to an audio output through a speaker 318 whose output is picked up by a microphone 308 and converted to an analog signal which is sampled and converted by the user interface controller 302 to a digital audio file at S222. The audio file 304 is time-stamped by the user interface controller 302 and transmitted to the patient control processor 300. The file is received at S240 by the patient control processor 300 at S240. The patient control processor determines at S250 whether the time stamp is recent and whether there is a good match between a stored pattern and the pattern received through the microphone 308.[P-47] Wyeth however fails to teach determining, based on the obtained audio signal, whether the physically separate device has outputted an audible alert indicative of the alert condition. Halbert on the other hand teaches determining, based on the obtained audio signal, whether the separate device has outputted an audible alert indicative of the alert condition (Paragraphs 4, 13, 20) Disclosed herein are systems and methods for ensuring that the sound level of an audible signal, or audio alert, generated by a bedside medical device is appropriate to a hospital environment in which the device is operating. The disclosed systems and methods increase the likelihood that a device annunciates alerts at an audio level that is perceivable by a clinician while minimizing the nuisance to the patient. In an embodiment, the system utilizes a built-in microphone to determine the ambient sound pressure and references a care area specific audio gain value to determine the appropriate dynamic alert/alarm sound pressure. The audio level can escalate if the generated alarm receives no user response within a specified period of time.[P-4] Disclosed herein are systems and methods for ensuring that the sound level of an audible alert generated by a bedside medical device is appropriate to a hospital environment in which the device is operating. The disclosed systems and methods increase the likelihood that a device annunciates alerts at an audio level that is perceivable by a clinician while minimizing the nuisance to the patient. In an embodiment, the system utilizes a built-in microphone to determine the ambient sound pressure and references a care area specific audio gain value to determine the appropriate dynamic alert/alarm sound pressure. The audio level can escalate if the generated alarm receives no user response within a specified period of time.[P-13] As mentioned, one or more of the infusion pumps includes at least one speaker for outputting an audio signal. In an embodiment, there is one main speaker that generates audio signals on behalf of all the pumps. FIG. 2 shows a schematic representation of an infusion pump 22 that includes an audio speaker 51. The infusion pump 22 also includes a sound detector 53 that is configured to detect a level of ambient sound. The sound detector 53 may be any device that is configured to detect sound or detect an ambient characteristic of sound level, such as pressure. Any of a variety of sound detection methods or devices may be used. The sound detector 53 and speaker 51 are both coupled to at least one microprocessor 55 that has access to software for analyzing and responding to a detected level of sound and for causing the speaker to emit an audio signal. The infusion pump may also include a user interface 57 that permits a user to interact with the infusion pump with respect to alarm conditions. [P-20] In a next step 310, the speaker emits an audio signal with a sound level of the audio signal at least partially based on ambient conditions. That is, the sound level of the audio signal is at least partially based on the environment in which the infusion pump and/or the patient are located. In an embodiment, the environmental conditions are determined and detected in real time. For example, the sound level of the audio signal may be based at least partially on a detected level of ambient sounds wherein the speaker generates a louder audio signal if the detected level of ambient sound is above a threshold. Or the speaker may generate a less loud audio signal if the detected level of ambient sound is below a threshold.[P-22] Thereby using the microphone to detect the emitted alert/alarm sound signal, the appropriate alarm/alert signal is determined indicative of the emitted sound alarm condition, and from there if the desired alert condition is not met, the speaker may be configured to sound the appropriate sound signal accordingly. The speaker being a separate component of the entire system is not specifically a physically separate device. However, since the claim is a method claim, the structural limitation in this case does not affect the overall inventive method, specifically if the structure does not directly affect how the method claim is effectively operated. Furthermore, the speaker device being physically separate or just a separate component/device within an overall medical system performs the same operation/function in the role of the entire method, and therefore obviously, its structural placement does not affect the overall method being performed [See MPEP § 2144.04.] It would therefore be obvious to one of ordinary skill in the art during the filing date of the said invention to combine Halbert’s teaching with Wyeth’s teaching in order to ensure and adjust audio signals based on the environment where the audio signal is being generated. In regards to claim 2, Wyeth modified teaches determining, based on the audio signal generated by the microphone, that the physically separate device has outputted the audible alert comprises determining that a frequency of a tone in the audio signal obtained by the microphone matches an expected frequency (Paragraph 54, Wyeth) One general aspect of the present disclosure includes a dialysis system for delivering treatment to a patient. The dialysis system also includes a user interface control processor configured to receive a test pattern from a patient control processor and to output on an audio output device. The system also includes a microphone positioned to receive audio output from said audio output device and to generate an audio signal that is interpretable by the patient control processor and which audio signal can be compared to a predefined pattern to determine whether it matches the pattern or not. The system also includes the patient control processor being configured to output an error signal if the audio signal doesn’t match the predefined pattern. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.[P-54] In regards to claim 6, Wyeth modified teaches responsive to determining that the frequency of the tone in the audio signal captured by the microphone matches the expected frequency, determining, by the one or more processors, whether a signal strength of the tone exceeds a signal strength threshold.(Paragraphs 39, 43, 59, Wyeth) Referring now to Fig. 5, once treatment has begun, treatment machine 100 may, in embodiments, conduct ongoing monitoring for a treatment event indicative of an alarm condition S50. This way, proper functioning of the treatment machine 100 and/or computer system 140 will trigger production of an alarm in regard to an occurrence of the treatment event. As described above, such improper or unintended treatment refers to any situation in which either the treatment machine causes the performance of the treatment to result in an alarm signaling that one or more parameters or conditions of the treatment negate or deviate from one or more standards for the treatment. If no treatment event indicative of improper or unintended treatment is detected, treatment will proceed as indicated at S52. At S54, however, detection of such an event will cause treatment machine 100 and/or computer system 140 to trigger an alarm via speaker 156 or by means of a display 150 showing an image or both. At S50, the fidelity of the alarm output is evaluated and if correct, recover instructions corresponding to the alarm are generated. If the fidelity of the alarm is determined to be incorrect, a maintenance alarm is generated at S54. At S56, a verification is made to confirm whether the audio alarm did, in fact, sound. At S58, a verification is made to confirm whether a visual alarm did, in fact, present on the graphical output (e.g., on the display 150). [P-39] If the audio alarm is deemed to be inoperable at S62, the process continues to S59, where an alternate alarm is triggered, such as a visual alarm and/or transmitting electronic signals or radio signals to an external device or a server.[P-43] Implementations may include one or more of the following features. The method where: using the processor, generating a time indication in relation to the audio signal, the time signal indicating a time of the output on the audio output device, and the patient control processor is configured to output an error signal if the time indication is not contemporaneous with the audio output from said audio output device within a predefined range of time, the audio output device includes a speaker, the pattern includes an audio sound power. If the patient control processor detects an alarm condition during a treatment, it outputs an alarm signal to the user interface control processor for output to a speaker. The if the time indication is not contemporaneous with the audio output from said audio output device within said predefined range of time, then, using the patient control processor, preventing a use of a treatment machine. The if the time indication is not contemporaneous with the audio output from said audio output device within said predefined range of time, then, using patient control processor outputting a data maintenance instruction to the processor to be output on a display. The pattern includes a time or frequency pattern with a range of frequencies with a distinctive audio signature. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium.[P-59] i.e. the output alert signal is prevented due to an error in the frequency mismatch of an expected alarm signal frequency). The second audio signal corresponds to second audio captured by the microphone; and responsive to determining that the separate device has not outputted the second audible alert, outputting a backup alert, the alert indicative that maintenance of the medical devices is required In regards to claim 9, Wyeth modified teaches: performing, by the one or more processors, a test with the physically separate device, wherein performing the test comprises: causing transmission, by the one or more processors and to the physically separate device, a request to play a test tone, and determining, by the one or more processors, that the physically separate device has outputted the test tone(Paragraph 54, Wyeth) One general aspect of the present disclosure includes a dialysis system for delivering treatment to a patient. The dialysis system also includes a user interface control processor configured to receive a test pattern from a patient control processor and to output on an audio output device. The system also includes a microphone positioned to receive audio output from said audio output device and to generate an audio signal that is interpretable by the patient control processor and which audio signal can be compared to a predefined pattern to determine whether it matches the pattern or not. The system also includes the patient control processor being configured to output an error signal if the audio signal doesn’t match the predefined pattern. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.[P-54] In regards to claim 11, Wyeth teaches a system comprising: one or more processors; and one or more processor-readable media storing instructions which, when executed by one or more processors, cause performance of: determining, by a medical device, an occurrence of an alert condition(Paragraphs 55) Implementations may include one or more of the following features. The system where: the user interface is configured to generate a time indication in relation to the audio signal, the time signal indicating a time of the output on the audio output device, and the patient control processor is configured to output an error signal if the time indication is not contemporaneous with the audio output from said audio output device within a predefined range of time. The audio output device includes a speaker. The pattern includes an audio sound power. The if the time indication is not contemporaneous with the audio output from said audio output device within said predefined range of time, then the patient control processor prevents use of a treatment machine. If the patient control processor detects an alarm condition during a treatment, it outputs an alarm signal to the user interface control processor for output to a speaker. If the time indication is not contemporaneous with the audio output from said audio output device within said predefined range of time, then the patient control processor outputs a data maintenance instruction to the user interface control processor to be output on a display. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium. [P-55] Wyeth then teaches causing transmission, via a wireless communication channel and to a physically separate device, data indicative of the occurrence of the alert condition; after causing transmission of the data indicative of the occurrence of the alert condition(Paragraphs 25, 26, 59) Bus 146 may further allow for communication between computer 142 and a display 150, a keyboard 152, a mouse 154, a speaker 156, a microphone 158, and a camera 160 each providing respective functionality in accordance with various embodiments disclosed herein, for example, for configuring a treatment for the patient 122 and monitoring the patient 122 during that treatment. [P-25] Computer 142 may also implement a communication interface 162 to communicate with a network 164 to provide any functionality disclosed herein, for example, for notifying an operator (i.e., healthcare professional) of a treatment alarm and/or receiving instructions from the healthcare professional, reporting patient/device conditions in a distributed system for training a machine learning algorithm, logging data to a remote repository, etc. Communication interface 162 may be any such interface known in the art to provide wireless and/or wired communication, such as a network card or a modem.[P-26] Implementations may include one or more of the following features. The method where: using the processor, generating a time indication in relation to the audio signal, the time signal indicating a time of the output on the audio output device, and the patient control processor is configured to output an error signal if the time indication is not contemporaneous with the audio output from said audio output device within a predefined range of time, the audio output device includes a speaker, the pattern includes an audio sound power. If the patient control processor detects an alarm condition during a treatment, it outputs an alarm signal to the user interface control processor for output to a speaker. The if the time indication is not contemporaneous with the audio output from said audio output device within said predefined range of time, then, using the patient control processor, preventing a use of a treatment machine. The if the time indication is not contemporaneous with the audio output from said audio output device within said predefined range of time, then, using patient control processor outputting a data maintenance instruction to the processor to be output on a display. The pattern includes a time or frequency pattern with a range of frequencies with a distinctive audio signature. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium. [P-59] Here causing transmission, via a wireless communication channel or network and to a physically separate device such as a speaker, data indicative of the occurrence of the alert condition. Wyeth then teaches obtaining, using a microphone of the medical device, an audio signal (Paragraphs 47, The test pattern is applied to a user interface controller 302 which converts the test pattern S220 to an audio output through a speaker 318 whose output is picked up by a microphone 308 and converted to an analog signal which is sampled and converted by the user interface controller 302 to a digital audio file at S222. The audio file 304 is time-stamped by the user interface controller 302 and transmitted to the patient control processor 300. The file is received at S240 by the patient control processor 300 at S240. The patient control processor determines at S250 whether the time stamp is recent and whether there is a good match between a stored pattern and the pattern received through the microphone 308.[P-47] Wyeth however fails to teach determining, based on the obtained audio signal, whether the physically separate device has outputted an audible alert indicative of the alert condition. Halbert on the other hand teaches determining, based on the obtained audio signal, whether the physically separate device has outputted an audible alert indicative of the alert condition (Paragraphs 4, 13, 20) Disclosed herein are systems and methods for ensuring that the sound level of an audible signal, or audio alert, generated by a bedside medical device is appropriate to a hospital environment in which the device is operating. The disclosed systems and methods increase the likelihood that a device annunciates alerts at an audio level that is perceivable by a clinician while minimizing the nuisance to the patient. In an embodiment, the system utilizes a built-in microphone to determine the ambient sound pressure and references a care area specific audio gain value to determine the appropriate dynamic alert/alarm sound pressure. The audio level can escalate if the generated alarm receives no user response within a specified period of time.[P-4] Disclosed herein are systems and methods for ensuring that the sound level of an audible alert generated by a bedside medical device is appropriate to a hospital environment in which the device is operating. The disclosed systems and methods increase the likelihood that a device annunciates alerts at an audio level that is perceivable by a clinician while minimizing the nuisance to the patient. In an embodiment, the system utilizes a built-in microphone to determine the ambient sound pressure and references a care area specific audio gain value to determine the appropriate dynamic alert/alarm sound pressure. The audio level can escalate if the generated alarm receives no user response within a specified period of time.[P-13] As mentioned, one or more of the infusion pumps includes at least one speaker for outputting an audio signal. In an embodiment, there is one main speaker that generates audio signals on behalf of all the pumps. FIG. 2 shows a schematic representation of an infusion pump 22 that includes an audio speaker 51. The infusion pump 22 also includes a sound detector 53 that is configured to detect a level of ambient sound. The sound detector 53 may be any device that is configured to detect sound or detect an ambient characteristic of sound level, such as pressure. Any of a variety of sound detection methods or devices may be used. The sound detector 53 and speaker 51 are both coupled to at least one microprocessor 55 that has access to software for analyzing and responding to a detected level of sound and for causing the speaker to emit an audio signal. The infusion pump may also include a user interface 57 that permits a user to interact with the infusion pump with respect to alarm conditions. [P-20] In a next step 310, the speaker emits an audio signal with a sound level of the audio signal at least partially based on ambient conditions. That is, the sound level of the audio signal is at least partially based on the environment in which the infusion pump and/or the patient are located. In an embodiment, the environmental conditions are determined and detected in real time. For example, the sound level of the audio signal may be based at least partially on a detected level of ambient sounds wherein the speaker generates a louder audio signal if the detected level of ambient sound is above a threshold. Or the speaker may generate a less loud audio signal if the detected level of ambient sound is below a threshold.[P-22] Thereby using the microphone to detect the emitted alert/alarm sound signal, the appropriate alarm/alert signal is determined indicative of the emitted sound alarm condition, and from there if the desired alert condition is not met, the speaker may be configured to sound the appropriate sound signal accordingly. The speaker being a separate component of the entire system is not specifically a physically separate device. However, though the claim is a system claim, the structural limitation in this case does not affect the overall inventive entity, specifically if the structural placement does not directly affect how the system is effectively operated. Furthermore, the speaker device being physically separate or just a separate component/device within an overall medical system performs the same operation/function in the role of the entire invention, and therefore its structural placement obviously does not affect the overall method being performed [See MPEP § 2144.04.] It would therefore be obvious to one of ordinary skill in the art during the filing date of the said invention to combine Halbert’s teaching with Wyeth’s teaching in order to ensure and adjust audio signals based on the environment where the audio signal is being generated. In regards to claim 12, Wyeth modified teaches determining, based on the audio signal generated by the microphone, that the physically separate device has outputted the audible alert comprises determining that a frequency of a tone in the audio signal obtained by the microphone matches an expected frequency (Paragraph 54, Wyeth) One general aspect of the present disclosure includes a dialysis system for delivering treatment to a patient. The dialysis system also includes a user interface control processor configured to receive a test pattern from a patient control processor and to output on an audio output device. The system also includes a microphone positioned to receive audio output from said audio output device and to generate an audio signal that is interpretable by the patient control processor and which audio signal can be compared to a predefined pattern to determine whether it matches the pattern or not. The system also includes the patient control processor being configured to output an error signal if the audio signal doesn’t match the predefined pattern. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.[P-54] In regards to claim 16, Wyeth modified teaches responsive to determining that the frequency of the tone in the audio signal captured by the microphone matches the expected frequency, determining, by the one or more processors, whether a signal strength of the tone exceeds a signal strength threshold.(Paragraphs 39, 43, 59, Wyeth) Referring now to Fig. 5, once treatment has begun, treatment machine 100 may, in embodiments, conduct ongoing monitoring for a treatment event indicative of an alarm condition S50. This way, proper functioning of the treatment machine 100 and/or computer system 140 will trigger production of an alarm in regard to an occurrence of the treatment event. As described above, such improper or unintended treatment refers to any situation in which either the treatment machine causes the performance of the treatment to result in an alarm signaling that one or more parameters or conditions of the treatment negate or deviate from one or more standards for the treatment. If no treatment event indicative of improper or unintended treatment is detected, treatment will proceed as indicated at S52. At S54, however, detection of such an event will cause treatment machine 100 and/or computer system 140 to trigger an alarm via speaker 156 or by means of a display 150 showing an image or both. At S50, the fidelity of the alarm output is evaluated and if correct, recover instructions corresponding to the alarm are generated. If the fidelity of the alarm is determined to be incorrect, a maintenance alarm is generated at S54. At S56, a verification is made to confirm whether the audio alarm did, in fact, sound. At S58, a verification is made to confirm whether a visual alarm did, in fact, present on the graphical output (e.g., on the display 150). [P-39] If the audio alarm is deemed to be inoperable at S62, the process continues to S59, where an alternate alarm is triggered, such as a visual alarm and/or transmitting electronic signals or radio signals to an external device or a server.[P-43] Implementations may include one or more of the following features. The method where: using the processor, generating a time indication in relation to the audio signal, the time signal indicating a time of the output on the audio output device, and the patient control processor is configured to output an error signal if the time indication is not contemporaneous with the audio output from said audio output device within a predefined range of time, the audio output device includes a speaker, the pattern includes an audio sound power. If the patient control processor detects an alarm condition during a treatment, it outputs an alarm signal to the user interface control processor for output to a speaker. The if the time indication is not contemporaneous with the audio output from said audio output device within said predefined range of time, then, using the patient control processor, preventing a use of a treatment machine. The if the time indication is not contemporaneous with the audio output from said audio output device within said predefined range of time, then, using patient control processor outputting a data maintenance instruction to the processor to be output on a display. The pattern includes a time or frequency pattern with a range of frequencies with a distinctive audio signature. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium.[P-59] i.e. the output alert signal is prevented due to an error in the frequency mismatch of an expected alarm signal frequency). The second audio signal corresponds to second audio captured by the microphone; and responsive to determining that the separate device has not outputted the second audible alert, outputting a backup alert, the alert indicative that maintenance of the medical devices is required In regards to claim 19, Wyeth modified teaches: performing, by the one or more processors, a test with the physically separate device, wherein performing the test comprises: causing transmission, by the one or more processors and to the physically separate device, a request to play a test tone, and determining, by the one or more processors, that the physically separate device has outputted the test tone(Paragraph 54, Wyeth) One general aspect of the present disclosure includes a dialysis system for delivering treatment to a patient. The dialysis system also includes a user interface control processor configured to receive a test pattern from a patient control processor and to output on an audio output device. The system also includes a microphone positioned to receive audio output from said audio output device and to generate an audio signal that is interpretable by the patient control processor and which audio signal can be compared to a predefined pattern to determine whether it matches the pattern or not. The system also includes the patient control processor being configured to output an error signal if the audio signal doesn’t match the predefined pattern. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.[P-54] Allowable Subject Matter Claims 3-5, 7, 8, 10, 13, 14, 15, 17, 18 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable they overcome the non-statutory double patenting rejection above, and if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claim 3 reads as follows; “The method of claim 2, wherein determining, that the frequency of the tone in the audio signal captured by the microphone matches the expected frequency comprises determining, by the one or more processors, the expected frequency associated with the alert condition from a plurality of expected frequencies associated with a plurality of alert conditions.” There was no prior art during the time of the filing date that taught the limitations of the claim alongside its parent claim(s) Claim 4 reads as follows; “The method of claim 2, wherein determining that the frequency of the tone in the audio signal captured by the microphone matches the expected frequency is based on a severity level associated with the alert condition.” There was no prior art during the time of the filing date of the said invention that taught the limitations of the claim alongside its parent claim(s). Dependent claim 5 is objected for the same rationale. Claim 7 reads as follows; “The method of claim 1, further comprising: determining an occurrence of a second alert condition; causing transmission, to the physically separate device, of data indicative of the occurrence of the second alert condition; after causing transmission of the data indicative of the occurrence of the second alert condition to the physically separate device, determining, based on a second audio signal obtained by the microphone of the medical device, that the physically separate device has not outputted a second audible alert; and responsive to determining that the physically separate device has not outputted the second audible alert, causing output of a backup alert.” There was no prior art during the time of the filing date of the said invention that taught the limitations of the claim alongside its parent claim(s). Dependent claim 8 is objected for the same rationale. Claim 10 reads as follows; “The method of claim 1, further comprising applying a Goertzel filter to the audio signal to determine whether the physically separate device has outputted the audible alert.” There was no prior art during the time of the filing date of the said invention that taught the limitations of the claim alongside its parent claim(s). Claim 13 reads as follows; “The system of claim 12, wherein determining, that the frequency of the tone in the audio signal captured by the microphone matches the expected frequency comprises determining the expected frequency associated with the alert condition from a plurality of expected frequencies associated with a plurality of alert conditions. There was no prior art during the time of the filing date that taught the limitations of the claim alongside its parent claim(s) Claim 14 reads as follows; “The system of claim 12, wherein determining that the frequency of the tone in the audio signal captured by the microphone matches the expected frequency is based on a severity level associated with the alert condition.” There was no prior art during the time of the filing date of the said invention that taught the limitations of the claim alongside its parent claim(s). Dependent claim 15 is objected for the same rationale. Claim 17 reads as follows; “The system of claim 11, wherein the instructions further cause performance of: determining an occurrence of a second alert condition; causing transmission, to the physically separate device, of data indicative of the occurrence of the second alert condition; after causing transmission of the data indicative of the occurrence of the second alert condition to the physically separate device, determining, based on a second audio signal obtained by the microphone of the medical device, that the physically separate device has not outputted a second audible alert; and responsive to determining that the physically separate device has not outputted the second audible alert, causing output of a backup alert.” There was no prior art during the time of the filing date of the said invention that taught the limitations of the claim alongside its parent claim(s). Dependent claim 18 is objected for the same rationale. Claim 20 reads as follows; “The system of claim 11, wherein the instructions further cause performance of applying a Goertzel filter to the audio signal to determine whether the physically separate device has outputted the audible alert. There was no prior art during the time of the filing date of the said invention that taught the limitations of the claim alongside its parent claim(s). Response to Arguments The examiner acknowledges applicants arguments pertaining to Halbert et al. (US 20150054651 A1) failing to teach “causing transmission, via a wireless communication channel and to a physically separate device.” As well as, “determining, based on the obtained audio signal, whether the physically separate device has outputted an audible alert indicative of the alert condition.”, specifically the said device being separate from the medical device. Regarding claim 1, Halbert’s teaching of the speaker being a separate component of the entire system is not specifically a physically separate device. However, since the claim is a method claim, the structural limitation in this case does not affect the overall inventive method, specifically if the structure does not directly affect how the method claim is effectively operated. Furthermore, the speaker device being physically separate or just a separate component/device within an overall medical system performs the same operation/function in the role of the entire method, and therefore its structural placement does not affect the overall method being performed [See MPEP § 2144.04.] Furthermore, regarding claim 11, Halbert’s teaching of the speaker being a separate component of the entire system is not specifically a physically separate device. However, though the claim is a system claim, the structural limitation in this case does not affect the overall inventive entity, specifically if the structural placement does not directly affect how the system is effectively operated. Furthermore, the speaker device being physically separate or just a separate component/device within an overall medical system, still performs the same operation/function in the role of the entire invention, and therefore its structural placement obviously does not affect the overall method being performed [See MPEP § 2144.04.] Conclusion THIS ACTION IS MADE FINAL. 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 ANTHONY D AFRIFA-KYEI whose telephone number is (571)270-7826. The examiner can normally be reached Monday-Friday 10am-7pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BRIAN ZIMMERMAN can be reached at 571-272-3059. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ANTHONY D AFRIFA-KYEI/Examiner, Art Unit 2686 /BRIAN A ZIMMERMAN/Supervisory Patent Examiner, Art Unit 2686
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Prosecution Timeline

Apr 08, 2024
Application Filed
Sep 16, 2025
Non-Final Rejection — §103, §DP
Nov 28, 2025
Interview Requested
Dec 04, 2025
Applicant Interview (Telephonic)
Dec 10, 2025
Response Filed
Dec 11, 2025
Examiner Interview Summary
Feb 14, 2026
Final Rejection — §103, §DP
Apr 10, 2026
Interview Requested

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
65%
Grant Probability
78%
With Interview (+13.5%)
3y 0m
Median Time to Grant
Moderate
PTA Risk
Based on 546 resolved cases by this examiner. Grant probability derived from career allow rate.

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