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 May 7th, 2026, claims 1, 11-13, 16, 17, 19 and 20 have been amended, claim 18 has been cancelled and new claim 21 has been added. Therefore, claims 1-17, 19-21 are pending for examination.
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/07/2026 has been entered.
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 and 9 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]
Halbert also teaches causing transmission, via a short-range wireless communication channel and to a physically separate device (Paragraph 28)
The communications system may take the form of a radio frequency ("RF") (radio frequency) system, an optical system such as infrared, a Bluetooth system, or other wired or wireless system. The bar code scanner and communications system may alternatively be included integrally with the infusion pump 24, such as in cases where a programming module is not used, or in addition to one with the programming module. Further, information input devices need not be hard-wired to medical instruments, information may be transferred through a wireless connection as well.[P-28]
Here, Halbert illustrates medical devices using short range communication such as Bluetooth to communicate information to different internal and external components and instruments alike.
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]
Claim(s) 3 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) as applied to claim 2 above, and further in view of Lee et al. (KR 20190052394 A)
In regards to claim 3, Wyeth modified fails to teach 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
Lee on the other hand teaches 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(Page 8, Paragraph 5; Page 9, Paragraph 3)
Referring to FIG. 4A, the electronic device 101 may include a microphone 300, an audio module 170, and a processor 120. For example, the electronic device 101 may detect the input signal through the microphone 300. [ For example, the electronic device 101 may analyze the input signal of the microphone 300 via the audio module 170 and may generate pattern data based on the analyzed input signal prior to performing the speech recognition preprocessing . Alternatively, the electronic device 101 may generate pattern data after the speech recognition pre-processing, or substantially simultaneously, through the audio module 170. In one example, the electronic device 101 may transmit voice data and pattern data to the processor 120 via the audio module 170. For example, the processor 120 may store the received voice data in the memory 130 of FIG. 1 as voice content or perform a function corresponding to the voice data and execute a function corresponding to the received pattern data.[Pg 8, P-5]
According to one embodiment, the processor 120 may generate pattern data by analyzing the frequency pattern of the input signals of the plurality of microphones 300. [ For example, the processor 120 may generate pattern data when the frequency pattern of the input signal of the microphone 300 matches or is similar to the reference frequency pattern at the time when the input of the user is detected.[Pg 9, P-3]
Here we see, Lee teach frequency of the tone in the audio signal captured by the microphone matches the expected frequency comprises determining, by the one or more processors, when combined with Wyeth’s teaching, it is obvious to one of ordinary skill in the art to enable the application of this system such that the expected frequency may be associated with the alert condition from a plurality of expected frequencies associated with a plurality of alert conditions, for the purpose of ensuring the correct expected output is executed.
Claim(s) 4, 5 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) and Lee et al. (KR 20190052394 A) as applied to claim 3 above, and further in view of Kaib et al. (US 20160328529 A1)
In regards to claim 4, Wyeth modified via Lee teaches determining that the frequency of the tone in the audio signal captured by the microphone matches the expected frequency (Page 8, Paragraph 5; Page 9, Paragraph 3)
Referring to FIG. 4A, the electronic device 101 may include a microphone 300, an audio module 170, and a processor 120. For example, the electronic device 101 may detect the input signal through the microphone 300. [ For example, the electronic device 101 may analyze the input signal of the microphone 300 via the audio module 170 and may generate pattern data based on the analyzed input signal prior to performing the speech recognition preprocessing . Alternatively, the electronic device 101 may generate pattern data after the speech recognition pre-processing, or substantially simultaneously, through the audio module 170. In one example, the electronic device 101 may transmit voice data and pattern data to the processor 120 via the audio module 170. For example, the processor 120 may store the received voice data in the memory 130 of FIG. 1 as voice content or perform a function corresponding to the voice data and execute a function corresponding to the received pattern data.[Pg 8, P-5]
According to one embodiment, the processor 120 may generate pattern data by analyzing the frequency pattern of the input signals of the plurality of microphones 300. [ For example, the processor 120 may generate pattern data when the frequency pattern of the input signal of the microphone 300 matches or is similar to the reference frequency pattern at the time when the input of the user is detected.[Pg 9, P-3]
Wyeth modified fails to teach determining that the frequency based on a severity/urgency level associated with the alert condition
Kaib on the other hand teaches teach determining that the frequency based on a severity/urgency level associated with the alert condition (Paragraph 126)
In examples of the present disclosure, a microphone associated with the speaker assembly 714 detects a background noise level (i.e., background sound pressure level), and, in cooperation with a processor, enables adaptation of a sound pressure level of an alarm (or other acoustic output) according to an urgency of the alarm. Also, more urgent alarms can have greater volumes that lower priority alarms. For example, as described in IEC 60601-1-8:2003(E), moderate priority alarms can be configured to have a volume level approximately 6 dB lower than a volume level for high priority alarm. In other examples, the volume level for a moderate priority alarm is from 0 dB to 12 dB lower than a volume level for a corresponding high priority alarm.[P-126]
Therefore, it is obvious to one of ordinary skill in the art to combine Lee’s teaching Wyeth modified’s teaching, thereby enabling the frequency matching of captured output alerts, based on a specific stored parameter to better accurately determine the correct output is executed.
In regards to claim 5, Wyeth modified via Kaib teaches 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 severity level associated with the alert condition, and determining, by the one or more processors, the expected frequency associated with the severity level from a plurality of expected frequencies associated with a plurality of severity levels. (Paragraph 126)
In examples of the present disclosure, a microphone associated with the speaker assembly 714 detects a background noise level (i.e., background sound pressure level), and, in cooperation with a processor, enables adaptation of a sound pressure level of an alarm (or other acoustic output) according to an urgency of the alarm. Also, more urgent alarms can have greater volumes that lower priority alarms. For example, as described in IEC 60601-1-8:2003(E), moderate priority alarms can be configured to have a volume level approximately 6 dB lower than a volume level for high priority alarm. In other examples, the volume level for a moderate priority alarm is from 0 dB to 12 dB lower than a volume level for a corresponding high priority alarm.[P-126]
When combined with Lee’s teach frequency of the tone in the audio signal captured by the microphone matches the expected frequency from a plurality of frequencies, the one of ordinary skill in the art may then configure the matching criteria to be predicated on the expected frequency associated with the severity level from a plurality of expected frequencies associated with a plurality of severity levels.
Claim(s) 11, 12, 16, 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) and Taketomi (JP 2009056118 A).
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]
Halbert also teaches causing transmission, via a short-range wireless communication channel and to a physically separate device (Paragraph 28)
The communications system may take the form of a radio frequency ("RF") (radio frequency) system, an optical system such as infrared, a Bluetooth system, or other wired or wireless system. The bar code scanner and communications system may alternatively be included integrally with the infusion pump 24, such as in cases where a programming module is not used, or in addition to one with the programming module. Further, information input devices need not be hard-wired to medical instruments, information may be transferred through a wireless connection as well.[P-28]
Here, Halbert illustrates medical devices using short range communication such as Bluetooth to communicate information to different internal and external components and instruments alike.
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.
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.
Wyeth fails to teach system for communication between a medical device and a physically separate device, further determining based on the obtained audio signal from the physically separate device, whether the physically separate device has outputted an audible alert indicative of the alert condition.
Taketomi on the other hand teaches communication between a medical device and a physically separate device, further determining based on the obtained audio signal from the physically separate device, whether the physically separate device has outputted an audible alert indicative of the alert condition (Abstract; Page 3, Paragraphs 1, 2; Page 5, Paragraphs 3, 4)
The medical instrument monitor stores an alarm sound in a second storage section 7 as testing sound data. A testing control section 6 reproduces the sound data stored in the second storage section 7 by a reproduction section 9 and outputs it from a speaker 10. The monitor inputs the output testing sound by a microphone 1, converts it to a testing pulse signal by a conversion section 2 and judges whether it coincides with frequency data by a detection section 4. Thus, during testing, the monitor outputs sound data stored in the second storage section 7 from the speaker 10 as a testing sound, inputs it by the microphone 1, and compares it with frequency data stored in a first storage section 3. Consequently, the monitor can easily inspect even a single instrument without requiring much labor including the arrangement of necessary medical instruments[Abstract]
Hereinafter, an embodiment of the present invention will be described with reference to the drawings. FIG. 1 is a block diagram illustrating a configuration example of the medical device monitoring apparatus according to the present embodiment. In this embodiment, a case where an alarm sound of a medical device used by a patient near a hospital bed in a hospital room is set as a detection target will be described as an example of a medical device used in a hospital. As shown in FIG. 1, the medical device monitoring apparatus according to the present embodiment includes a microphone (corresponding to a voice input unit in claims) 1, a conversion unit 2, a first storage unit 3, a detection unit 4, and an interface 5. , Test control unit 6, second storage unit 7, test operation unit 8, reproduction unit (corresponding to the test audio data reproduction unit in claims) 9, speaker (in the sound emission unit in the claims) (Applicable) 10 is provided. Further, as shown in FIG. 2, the detection unit 4 includes an address counter 4a, a control circuit 4b, a pulse width measurement circuit 4c, a pulse width comparison circuit 4d, a pulse width similarity counter 4e, and a coincidence detection circuit 4f. Yes.[Pg 3, P-1]
The microphone 1 is used in the vicinity of a medical device. Moreover, the microphone 1 inputs a sound including an alarm sound emitted from a medical device as an input sound. The converter 2 converts the input sound input to the microphone 1 into an input sound signal that is an analog electric signal. Moreover, the conversion part 2 takes out the sound signal of the zone | band currently used for the alarm sound of a medical device from the converted input sound signal. Here, the conversion unit 2 uses a comparator or the like to select whether the extracted sound signal is from a medical device installed in the vicinity of the microphone 1. For this reason, a threshold of a predetermined level is set in advance in the comparator. This threshold value is set to a level at which a sound signal corresponding to the sound of the minimum volume output from the medical device is detected. Thus, when the sound signal exceeds the threshold value, the comparator sends an enable signal indicating that the sound signal is effective as a recognition process target to the detection unit 4. Further, when the sound signal is equal to or lower than the threshold value, the comparator sends a disable signal indicating that the sound signal is ignored to the detection unit 4.[Pg 3, P-2]
As described above in detail, according to the present embodiment, the width of each pulse of the pulse signal obtained by converting the alarm sound generated by the medical device is stored in advance in the first storage unit 3 as frequency data. In this state, when the medical device emits an alarm sound, the microphone 1 inputs an input sound including the alarm sound, and the conversion unit 2 converts the input sound into an input sound signal, and the band of the alarm sound from the input sound signal. Are extracted and converted to pulse signals. The detection unit 4 determines whether the pulse width of the pulse signal converted by the conversion unit 2 is similar to the pulse width of the frequency data read from the first storage unit 3, and the number of similar pulses is determined. A match between the frequency data and the pulse signal is determined. On the other hand, the alarm sound is stored in the second storage unit 7 as test sound data. When the test operation unit 8 is operated in this state, the test control unit 6 reproduces the test audio data stored in the second storage unit 7 by the reproduction unit 9 and outputs the test audio from the speaker 10. Output as. The output test sound is input by the microphone 1 and converted to a test pulse signal by the conversion unit 2, and the detection unit 4 determines whether or not it matches the frequency data.[Pg 5, P-3]
As a result, an alarm sound equivalent to the alarm sound emitted by the medical device is stored in the second storage unit 7 as sound data. During the test, the sound data is output from the speaker 10 as test sound, and the microphone 1 Since the comparison with the frequency data stored in the first storage unit 3 is performed in the same manner as in the actual processing, medical care can be performed without much effort such as preparing necessary medical equipment. Inspections such as operation tests can be easily performed even with a single device monitoring device.[Pg 5, P-4]
Here we see Taketomi teach a medical device with a speaker, configured to test the output of an alarm signal from a speaker, to which a nearby microphone detects the output signal converts the received signal and determine if the appropriate alarm is omitted by the speaker.
Therefore when combined with Wyeth modified’s teaching, one of ordinary skill in the art may obviously apply Taketomi’s inventive entity to enable the communication between a medical device and a physically separate device, further determining based on the obtained audio signal from the physically separate device, whether the physically separate device has outputted an audible alert indicative of the alert condition
It is therefore obvious to one of ordinary skill in the art to combine Taketomi’s teaching with Wyeth’s teaching in order to enable a more effective way to determine the appropriate alert/alarm signal is output by a designated speaker
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]
Claim(s) 13 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) and Taketomi (JP 2009056118 A) as applied to claim 11 above, and further in view of Lee et al. (KR 20190052394 A)
In regards to claim 13, Wyeth modified fails to teach 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
Lee on the other hand teaches 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(Page 8, Paragraph 5; Page 9, Paragraph 3)
Referring to FIG. 4A, the electronic device 101 may include a microphone 300, an audio module 170, and a processor 120. For example, the electronic device 101 may detect the input signal through the microphone 300. [ For example, the electronic device 101 may analyze the input signal of the microphone 300 via the audio module 170 and may generate pattern data based on the analyzed input signal prior to performing the speech recognition preprocessing . Alternatively, the electronic device 101 may generate pattern data after the speech recognition pre-processing, or substantially simultaneously, through the audio module 170. In one example, the electronic device 101 may transmit voice data and pattern data to the processor 120 via the audio module 170. For example, the processor 120 may store the received voice data in the memory 130 of FIG. 1 as voice content or perform a function corresponding to the voice data and execute a function corresponding to the received pattern data.[Pg 8, P-5]
According to one embodiment, the processor 120 may generate pattern data by analyzing the frequency pattern of the input signals of the plurality of microphones 300. [ For example, the processor 120 may generate pattern data when the frequency pattern of the input signal of the microphone 300 matches or is similar to the reference frequency pattern at the time when the input of the user is detected.[Pg 9, P-3]
Here we see, Lee teach frequency of the tone in the audio signal captured by the microphone matches the expected frequency comprises determining, by the one or more processors, when combined with Wyeth’s teaching, it is obvious to one of ordinary skill in the art to enable the application of this system such that the expected frequency may be associated with the alert condition from a plurality of expected frequencies associated with a plurality of alert conditions, for the purpose of ensuring the correct expected output is executed.
Claim(s) 14, 15 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), Taketomi (JP 2009056118 A) and Lee et al. (KR 20190052394 A) as applied to claim 13 above, and further in view of Kaib et al. (US 20160328529 A1)
In regards to claim 14, Wyeth modified via Lee teaches determining that the frequency of the tone in the audio signal captured by the microphone matches the expected frequency (Page 8, Paragraph 5; Page 9, Paragraph 3)
Referring to FIG. 4A, the electronic device 101 may include a microphone 300, an audio module 170, and a processor 120. For example, the electronic device 101 may detect the input signal through the microphone 300. [ For example, the electronic device 101 may analyze the input signal of the microphone 300 via the audio module 170 and may generate pattern data based on the analyzed input signal prior to performing the speech recognition preprocessing . Alternatively, the electronic device 101 may generate pattern data after the speech recognition pre-processing, or substantially simultaneously, through the audio module 170. In one example, the electronic device 101 may transmit voice data and pattern data to the processor 120 via the audio module 170. For example, the processor 120 may store the received voice data in the memory 130 of FIG. 1 as voice content or perform a function corresponding to the voice data and execute a function corresponding to the received pattern data.[Pg 8, P-5]
According to one embodiment, the processor 120 may generate pattern data by analyzing the frequency pattern of the input signals of the plurality of microphones 300. [ For example, the processor 120 may generate pattern data when the frequency pattern of the input signal of the microphone 300 matches or is similar to the reference frequency pattern at the time when the input of the user is detected.[Pg 9, P-3]
Wyeth modified fails to teach determining that the frequency based on a severity/urgency level associated with the alert condition
Kaib on the other hand teaches teach determining that the frequency based on a severity/urgency level associated with the alert condition (Paragraph 126)
In examples of the present disclosure, a microphone associated with the speaker assembly 714 detects a background noise level (i.e., background sound pressure level), and, in cooperation with a processor, enables adaptation of a sound pressure level of an alarm (or other acoustic output) according to an urgency of the alarm. Also, more urgent alarms can have greater volumes that lower priority alarms. For example, as described in IEC 60601-1-8:2003(E), moderate priority alarms can be configured to have a volume level approximately 6 dB lower than a volume level for high priority alarm. In other examples, the volume level for a moderate priority alarm is from 0 dB to 12 dB lower than a volume level for a corresponding high priority alarm.[P-126]
Therefore, it is obvious to one of ordinary skill in the art to combine Lee’s teaching Wyeth modified’s teaching, thereby enabling the frequency matching of captured output alerts, based on a specific stored parameter to better accurately determine the correct output is executed.
In regards to claim 15, Wyeth modified via Kaib teaches 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 severity level associated with the alert condition, and determining, by the one or more processors, the expected frequency associated with the severity level from a plurality of expected frequencies associated with a plurality of severity levels. (Paragraph 126)
In examples of the present disclosure, a microphone associated with the speaker assembly 714 detects a background noise level (i.e., background sound pressure level), and, in cooperation with a processor, enables adaptation of a sound pressure level of an alarm (or other acoustic output) according to an urgency of the alarm. Also, more urgent alarms can have greater volumes that lower priority alarms. For example, as described in IEC 60601-1-8:2003(E), moderate priority alarms can be configured to have a volume level approximately 6 dB lower than a volume level for high priority alarm. In other examples, the volume level for a moderate priority alarm is from 0 dB to 12 dB lower than a volume level for a corresponding high priority alarm.[P-126]
When combined with Lee’s teach frequency of the tone in the audio signal captured by the microphone matches the expected frequency from a plurality of frequencies, the one of ordinary skill in the art may then configure the matching criteria to be predicated on the expected frequency associated with the severity level from a plurality of expected frequencies associated with a plurality of severity levels.
Claim(s) 21 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), Taketomi (JP 2009056118 A) and Lee et al. (KR 20190052394 A).
In regards to claim 21, 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]
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.
Wyeth fails to teach system for communication between a medical device and a physically separate device, further determining based on the obtained audio signal from the physically separate device, whether the physically separate device has outputted an audible alert indicative of the alert condition.
Taketomi on the other hand teaches communication between a medical device and a physically separate device, further determining based on the obtained audio signal from the physically separate device, whether the physically separate device has outputted an audible alert indicative of the alert condition (Abstract; Page 3, Paragraphs 1, 2; Page 5, Paragraphs 3, 4)
The medical instrument monitor stores an alarm sound in a second storage section 7 as testing sound data. A testing control section 6 reproduces the sound data stored in the second storage section 7 by a reproduction section 9 and outputs it from a speaker 10. The monitor inputs the output testing sound by a microphone 1, converts it to a testing pulse signal by a conversion section 2 and judges whether it coincides with frequency data by a detection section 4. Thus, during testing, the monitor outputs sound data stored in the second storage section 7 from the speaker 10 as a testing sound, inputs it by the microphone 1, and compares it with frequency data stored in a first storage section 3. Consequently, the monitor can easily inspect even a single instrument without requiring much labor including the arrangement of necessary medical instruments[Abstract]
Hereinafter, an embodiment of the present invention will be described with reference to the drawings. FIG. 1 is a block diagram illustrating a configuration example of the medical device monitoring apparatus according to the present embodiment. In this embodiment, a case where an alarm sound of a medical device used by a patient near a hospital bed in a hospital room is set as a detection target will be described as an example of a medical device used in a hospital. As shown in FIG. 1, the medical device monitoring apparatus according to the present embodiment includes a microphone (corresponding to a voice input unit in claims) 1, a conversion unit 2, a first storage unit 3, a detection unit 4, and an interface 5. , Test control unit 6, second storage unit 7, test operation unit 8, reproduction unit (corresponding to the test audio data reproduction unit in claims) 9, speaker (in the sound emission unit in the claims) (Applicable) 10 is provided. Further, as shown in FIG. 2, the detection unit 4 includes an address counter 4a, a control circuit 4b, a pulse width measurement circuit 4c, a pulse width comparison circuit 4d, a pulse width similarity counter 4e, and a coincidence detection circuit 4f. Yes.[Pg 3, P-1]
The microphone 1 is used in the vicinity of a medical device. Moreover, the microphone 1 inputs a sound including an alarm sound emitted from a medical device as an input sound. The converter 2 converts the input sound input to the microphone 1 into an input sound signal that is an analog electric signal. Moreover, the conversion part 2 takes out the sound signal of the zone | band currently used for the alarm sound of a medical device from the converted input sound signal. Here, the conversion unit 2 uses a comparator or the like to select whether the extracted sound signal is from a medical device installed in the vicinity of the microphone 1. For this reason, a threshold of a predetermined level is set in advance in the comparator. This threshold value is set to a level at which a sound signal corresponding to the sound of the minimum volume output from the medical device is detected. Thus, when the sound signal exceeds the threshold value, the comparator sends an enable signal indicating that the sound signal is effective as a recognition process target to the detection unit 4. Further, when the sound signal is equal to or lower than the threshold value, the comparator sends a disable signal indicating that the sound signal is ignored to the detection unit 4.[Pg 3, P-2]
As described above in detail, according to the present embodiment, the width of each pulse of the pulse signal obtained by converting the alarm sound generated by the medical device is stored in advance in the first storage unit 3 as frequency data. In this state, when the medical device emits an alarm sound, the microphone 1 inputs an input sound including the alarm sound, and the conversion unit 2 converts the input sound into an input sound signal, and the band of the alarm sound from the input sound signal. Are extracted and converted to pulse signals. The detection unit 4 determines whether the pulse width of the pulse signal converted by the conversion unit 2 is similar to the pulse width of the frequency data read from the first storage unit 3, and the number of similar pulses is determined. A match between the frequency data and the pulse signal is determined. On the other hand, the alarm sound is stored in the second storage unit 7 as test sound data. When the test operation unit 8 is operated in this state, the test control unit 6 reproduces the test audio data stored in the second storage unit 7 by the reproduction unit 9 and outputs the test audio from the speaker 10. Output as. The output test sound is input by the microphone 1 and converted to a test pulse signal by the conversion unit 2, and the detection unit 4 determines whether or not it matches the frequency data.[Pg 5, P-3]
As a result, an alarm sound equivalent to the alarm sound emitted by the medical device is stored in the second storage unit 7 as sound data. During the test, the sound data is output from the speaker 10 as test sound, and the microphone 1 Since the comparison with the frequency data stored in the first storage unit 3 is performed in the same manner as in the actual processing, medical care can be performed without much effort such as preparing necessary medical equipment. Inspections such as operation tests can be easily performed even with a single device monitoring device.[Pg 5, P-4]
Here we see Taketomi teach a medical device with a speaker, configured to test the output of an alarm signal from a speaker, to which a nearby microphone detects the output signal converts the received signal and determine if the appropriate alarm is omitted by the speaker.
Therefore when combined with Wyeth modified’s teaching, one of ordinary skill in the art may obviously apply Taketomi’s inventive entity to enable the communication between a medical device and a physically separate device, further determining based on the obtained audio signal from the physically separate device, whether the physically separate device has outputted an audible alert indicative of the alert condition
It is therefore obvious to one of ordinary skill in the art to combine Taketomi’s teaching with Wyeth’s teaching in order to enable a more effective way to determine the appropriate alert/alarm signal is output by a designated speaker
Wyeth modified fails to teach 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
Lee on the other hand teaches 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(Page 8, Paragraph 5; Page 9, Paragraph 3)
Referring to FIG. 4A, the electronic device 101 may include a microphone 300, an audio module 170, and a processor 120. For example, the electronic device 101 may detect the input signal through the microphone 300. [ For example, the electronic device 101 may analyze the input signal of the microphone 300 via the audio module 170 and may generate pattern data based on the analyzed input signal prior to performing the speech recognition preprocessing . Alternatively, the electronic device 101 may generate pattern data after the speech recognition pre-processing, or substantially simultaneously, through the audio module 170. In one example, the electronic device 101 may transmit voice data and pattern data to the processor 120 via the audio module 170. For example, the processor 120 may store the received voice data in the memory 130 of FIG. 1 as voice content or perform a function corresponding to the voice data and execute a function corresponding to the received pattern data.[Pg 8, P-5]
According to one embodiment, the processor 120 may generate pattern data by analyzing the frequency pattern of the input signals of the plurality of microphones 300. [ For example, the processor 120 may generate pattern data when the frequency pattern of the input signal of the microphone 300 matches or is similar to the reference frequency pattern at the time when the input of the user is detected.[Pg 9, P-3]
Here we see, Lee teach frequency of the tone in the audio signal captured by the microphone matches the expected frequency comprises determining, by the one or more processors, when combined with Wyeth’s teaching, it is obvious to one of ordinary skill in the art to enable the application of this system such that the expected frequency may be associated with the alert condition from a plurality of expected frequencies associated with a plurality of alert conditions, for the purpose of ensuring the correct expected output is executed.
Allowable Subject Matter
Claims 7, 8, 10, 17, 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 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 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).
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.]
Conclusion
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
Prosecution Insights