DETAILED ACTIONS
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 .
Election/Restrictions
Claims 17-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 3rd, 2025.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/01/2022, 02/02/2024, and 01/13/2025. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Witkowski et al. (WO2020101680 A1, hereinafter Witkowski)
Regrading Claim 1, Witkowski teaches,
A method of calibrating a blood flow monitoring device (Witkowski, Figure 2, Abstract, A Doppler blood flow monitoring device (150), [0029], vascular monitoring system, device and method are provided to improve the accessibility,
detection and/or reliability of detecting blood flow to confirm vessel patency at an anastomotic site) comprising:
positioning a remote device (Witkowski, Figure 5, [0061] “FIG. 5 illustrates an example system 400 with monitor 150 communicating with one or more of an administration station 470, cloud computing infrastructure 480 and
a user device 402 a user device 402” NOTE: Examiner interpreted “remote device” as any device in communication with the “doppler monitor” where doppler sound data stored or can be retrieved from. It is to note that the instant application specification refers in [0025] “remote device” as one of cellular phone, computers or cloud computing e.g., directly, through a cloud computing resource that the remote device can access) such that a clinician can view the patient data using the remote device (e.g., listen to Doppler sounds, view data”). And
a blood flow monitor (blood flow monitoring device 150), within physical proximity of one another (Witkowski, Figure 5, blood flow monitoring device 150, user device 402, also see [0070]
the remote device having a microphone and a speaker (Witkowski, Figure 5, a user device 402. [0075] “user device 402 may be a smartphone, tablet,
laptop, computer, smartwatch, or any other suitable device”. NOTE: It is known in the field of art that any of the exampled user devices comprises with speaker and microphone. See [0070]), the blood flow monitor having a speaker and configured to emit Doppler sounds (Witkowski, Figure 5, [0061], a receiver transmitter such as a universal asynchronous receiver-transmitter ("UART") 412, [0076], Doppler blood flow monitoring device includes a signal reception module, a signal filtration module, a signal conversion module, at least one speaker, and a user interface”).;
placing the remote device in a calibration mode such that the microphone of the remote device is active and can receive Doppler sounds emitted by the speaker of the blood flow monitor emitting Doppler sounds through the speaker of the blood flow monitor (Witkowski, Figures 5-6, [0069] “To improve the accessibility and ease of monitoring a patient, the user device 402 may run an application to remotely access the audio files 490 stored on database 488”. [0070] When accessing audio files on user device 402, a medical practitioner (e.g., surgeon) may request to listen to a "current" blood flow audio file. For example, as illustrated in FIG. 6, a medical practitioner (e.g., surgeon) may select the graphical representation of the "Request-Current" button 502 to listen to a "current recording" of the blood flow at the anastomotic site.”);
receiving the Doppler sounds as received Doppler sounds using the microphone of the remote device; emitting the received Doppler sounds through the speaker of the remote device as remote device sounds; receiving the remote device sounds using the microphone of the remote device (Witkowski, Figure 6, [0070] “For example, by selecting button 502, a 15 second recording of the audio signal of the patient's blood flow may be recorded and uploaded to database 488, which may then be retrieved and played by user device 402 to provide an audible indication of blood
flow via speakers of user device 402”).;
identifying any differences between the received Doppler sounds and the received remote device sounds; and calibrating the remote device based on the identified differences between the received Doppler sounds and the received remote device sounds. (Witkowski, Figure 6, [0070], The application may also allow a medical practitioner (e.g., surgeon) to play, listen to and review previous audio recordings for that patient. For example, by selecting any of the graphical representations of the "Previous Recording_1", "Previous Recording_2", or "Previous Recording_3" buttons 504, 506 or 508 respectively, the medical practitioner (e.g., surgeon) may listen to previous recordings of the audio signal of the patient's blood flow. By doing so, the surgeon may be able to compare the audio signals and determine if the patient's blood flow is improving, worsening or staying approximately the same”. [0073] For instance, various aspects concerning blood flow within a vessel can be monitored and recorded. With
access to several previous recordings, a medical practitioner (e.g., surgeon) can make an objective comparison between a current recording and previous recordings. For example, the qualitative visual indication 512 associated with a recording may provide a baseline value that can be compared to other recordings”).
Regrading Claim 2, Witkowski teaches the claim 1,
Witkowski further teaches wherein calibrating the remote device based on the identified differences between the received Doppler sounds and (Witkowski, Figure 4, [0057], “AFE 340 may receive 1 µSec and 0.8 µSec pulses@ 78 KHz from processor 310, which are then sent to Doppler probes or transducers 106. Then, AFE 340 receives return signals (e.g., of a phase shift) from the transducers 106, which are converted to audio signals and sent to filter 342 and/or AMP 350. The audio signals represent a phase shift or a Doppler shift detected by monitor 150, which is converted into audio”) the received remote device sounds is accomplished using. sound equalization characterization techniques (Witkowski, Figure 4, [0059] “The audio signal may be digitally filtered to control background noise levels. In another example, filter module 342 may perform a fast Fourier transform (FFT) of the signal to divide the audio signal into multiple frequency components that are digitally filtered. The digital filtering may include applying a bandpass (low and high) filter and a signal boost (e.g., a boost of 236Hz”).
Regrading Claim 3, Witkowski teaches the claim 1,
Witkowski further teaches wherein the Doppler sounds are pre-recorded characterized sounds (Witkowski, Figure, 4-5, [ 0069] “To improve the accessibility and ease of monitoring a patient, the user device 402 may run an application to remotely access the audio files 490 stored on database 488. users (e.g., surgeons) using the monitoring application on user device 402 may retrieve and play audio files associated with a specific implanted Doppler probe or transducer 106. For example, blood flow audio files for multiple patients in multiple different hospitals may be stored on database 488”).
Regrading Claim 4, Witkowski teaches the claim 1,
Witkowski further teaches wherein the Doppler sounds relate to patient data. (Witkowski, Figures 4-5 [0069], the monitoring application on user device 402 may retrieve and play audio files associated with a specific implanted Doppler probe or transducer 106. For example, blood flow audio files for multiple patients in multiple different hospitals may be stored on database 488”).
Regrading Claim 5, Witkowski teaches the claim 4,
Witkowski further teaches wherein the Doppler sounds relate to blood flow through a vein. (Witkowski, [0073] “For instance, various aspects concerning blood flow within a vessel can be monitored and recorded”).
Regrading Claim 6, Witkowski teaches the claim 4,
Witkowski further teaches, wherein the Doppler sounds relate to blood flow through an artery. (Witkowski, Figures1B, [0035] “The vascular coupler formed by the pair of fasteners 104 is adapted to create an end-to-end anastomosis of a blood vessel (e.g., a vein or artery) while retaining and maintaining the position of the transducer(s) 106 or other sensing device(s). The sensing devices, in turn, can be used to monitor or evaluate parameters associated with recovery and success of the surgical procedure, such as blood flow at an anastomotic site to confirm vessel patency”).
Regrading Claim 7, Witkowski teaches the claim 1,
Witkowski further teaches wherein receiving the Doppler sounds as received Doppler sounds using the microphone of the remote device is accomplished such that the received Doppler sounds are saved locally to the remote device. (Witkowski, Figures 4-5 [0062] Monitor 150 may communicate with a cloud computing infrastructure 480 (e.g., Amazon Web Services ("AWS")), which may include a backend server 482 (e.g. backend AWS Elastic Compute Cloud ("EC2") server), an audio server 484, a database search tool (e.g., Mongo DB), and a database 488 (e.g., Amazon Simple Storage Service ("S3"). [0064], “the user device 402 may communicate with the backend server 482 and the database 488 to play audio file 490”).
Regrading Claim 8, Witkowski teaches the claim 1,
Witkowski further teaches wherein receiving the remote device sounds using the microphone of the remote device is accomplished such that the received remote device sounds are saved locally to the remote device (Witkowski, Figure 5, [0070] For example, as illustrated in FIG. 6, a medical practitioner (e.g., surgeon) may select the graphical representation of the "Request-Current" button 502 to listen to a "current recording" of the blood flow at the anastomotic site. In an example, selecting the "Request-Current" button 502 may initiate a recording and thus may not be a real-time audio signal of the blood flow, but instead may be delayed by a brief period (e.g., 10 seconds, 15 seconds, 20 seconds, etc.). For example, by selecting button 502, a 15 second recording of the audio signal of the patient's blood flow may be recorded and uploaded to database 488, which may then be retrieved and played by user device 402 to provide an audible indication of
blood flow via speakers of user device 402. The application may also allow a medical practitioner (e.g., surgeon) to play, listen to and review previous audio recordings for that patient. For example, by selecting any of the graphical representations of the "Previous Recording_ l ", "Previous Recording_ 2", or "Previous Recording_ 3" buttons 5 04, 5 06 or 508 respectively, the medical practitioner (e.g., surgeon) may listen to previous recordings of the audio signal of the patient's blood flow. By doing so, the surgeon may be able to compare the audio signals and determine if the patient's blood flow is improving,
worsening or staying approximately the same” NOTE: Examiner interpreted “remote device” as any device in communication with the “doppler monitor” where doppler sound data stored or can be retrieved from. It is to note that the instant application specification refers in [0025] “remote device” as one of cellular phone, computers or cloud computing e.g., directly, through a cloud computing resource that the remote device can access) such that a clinician can view the patient data using the remote device (e.g., listen to Doppler sounds, view data”).
Regrading Claim 9, Witkowski teaches
A method of calibrating a blood flow monitoring device comprising:
placing a tissue flap at a point of treatment, the tissue flap including a section of tissue that includes a blood vessel (Witkowski, [0029] “[0029] As discussed above, vascular monitoring system, device and method are provided to improve the accessibility, detection and/or reliability of detecting blood flow to
confirm vessel patency at an anastomotic site. the vascular monitor system,
device and methods disclosed herein advantageously enable early detection of insufficient blood flow or circulation in a free flap”);
attaching a sensor to the tissue flap to monitor blood flow through the blood vessel, the sensor attached to the tissue flap such that it contacts the blood vessel (Witkowski, Figure7A-7CD, [0032] Probe systems (e.g., probe systems 102a and 102b, generally referred to herein as probe system 102 include a set of fasteners 104a, b that may form a vascular coupler that couples two veins and/or arteries in an end-to-end anastomosis (See FIG. 7 A). The probe systems 102 may each also include a transducer 106a, b (See FIG. 7A, 7B, 7C and 7D) connected to at least one of the fasteners104a, b. For example, one ring may include a probe holder with a press-fit Doppler Probe or transducer 106. In an example, a set or pair of fasteners (e.g., set of fasteners 104a, generally referred to herein as fasteners104) may include a pair of high-density polyethylene ("HDPE") rings with stainless steel pins (See FIG. 7C and FIG. 7D). The pair of rings form a permanent implant within the patient.”);attaching the sensor to a blood flow monitor (Witkowski, Figure 1B, [0031], It should be appreciated that while the embodiments illustrated in FIG. IA and FIG. IB use leads 110a, 110b to connect the probe systems 102a, 102b to the monitor 150, a wireless system may also be used wherein the probe is configured to communicate with the monitor without the use of leads 110”) having a speaker and configured to emit Doppler sounds(Witkowski, Figures 4, Speakers 314a-314b [0047];” Monitor 150 may include speakers 314a and 314b (hereinafter referred to generally as speakers 314”),
activating the blood flow monitor such that the blood flow monitor is monitoring blood flow through the blood vessel (Witkowski, Figure1B, 7A-7D, [0007] “a Doppler blood flow monitoring device includes a signal generation module, a signal reception module, a signal filtration module, a signal conversion module, at least one speaker, and a user interface. The signal generation module is configured to send a signal to a probe positioned in a probe receptacle on a vascular coupler positioned about a patient's vessel. The signal reception module is configured to receive a return signal from the probe”).;
positioning a remote device (Witkowski, Figure 5, [0061] “FIG. 5 illustrates an example system 400 with monitor 150 communicating with one or more of an administration station 470, cloud computing infrastructure 480 and
a user device 402 a user device 402” NOTE: Examiner interpreted “remote device” as any device in communication with the “doppler monitor” where doppler sound data stored or can be retrieved from. It is to note that the instant application specification refers in [0025] “remote device” as one of cellular phone, computers or cloud computing e.g., directly, through a cloud computing resource that the remote device can access) such that a clinician can view the patient data using the remote device (e.g., listen to Doppler sounds, view data”). And
a blood flow monitor (blood flow monitoring device 150), within physical proximity of one another (Witkowski, Figure 5, blood flow monitoring device 150, user device 402, also see [0070]
the remote device having a microphone and a speaker (Witkowski, Figure 5, a user device 402. [0075] “user device 402 may be a smartphone, tablet,
laptop, computer, smartwatch, or any other suitable device”. NOTE: It is known in the field of art that any of the exampled user devices comprises with speaker and microphone. See [0070]), the blood flow monitor having a speaker and configured to emit Doppler sounds (Witkowski, Figure 5, [0061], a receiver transmitter such as a universal asynchronous receiver-transmitter ("UART") 412, [0076], Doppler blood flow monitoring device includes a signal reception module, a signal filtration module, a signal conversion module, at least one speaker, and a user interface”).;
placing the remote device in a calibration mode such that the microphone of the remote device is active and can receive Doppler sounds emitted by the speaker of the blood flow monitor emitting Doppler sounds through the speaker of the blood flow monitor (Witkowski, Figures 5-6, [0069] “To improve the accessibility and ease of monitoring a patient, the user device 402 may run an application to remotely access the audio files 490 stored on database 488”. [0070] When accessing audio files on user device 402, a medical practitioner (e.g., surgeon) may request to listen to a "current" blood flow audio file. For example, as illustrated in FIG. 6, a medical practitioner (e.g., surgeon) may select the graphical representation of the "Request-Current" button 502 to listen to a "current recording" of the blood flow at the anastomotic site.”);
receiving the Doppler sounds as received Doppler sounds using the microphone of the remote device; emitting the received Doppler sounds through the speaker of the remote device as remote device sounds; receiving the remote device sounds using the microphone of the remote device (Witkowski, Figure 6, [0070] “For example, by selecting button 502, a 15 second recording of the audio signal of the patient's blood flow may be recorded and uploaded to database 488, which may then be retrieved and played by user device 402 to provide an audible indication of blood
flow via speakers of user device 402”).;
identifying any differences between the received Doppler sounds and the received remote device sounds; and calibrating the remote device based on the identified differences between the received Doppler sounds and the received remote device sounds. (Witkowski, Figure 6, [0070], The application may also allow a medical practitioner (e.g., surgeon) to play, listen to and review previous audio recordings for that patient. For example, by selecting any of the graphical representations of the "Previous Recording_1", "Previous Recording_2", or "Previous Recording_3" buttons 504, 506 or 508 respectively, the medical practitioner (e.g., surgeon) may listen to previous recordings of the audio signal of the patient's blood flow. By doing so, the surgeon may be able to compare the audio signals and determine if the patient's blood flow is improving, worsening or staying approximately the same”. [0073] For instance, various aspects concerning blood flow within a vessel can be monitored and recorded. With
access to several previous recordings, a medical practitioner (e.g., surgeon) can make an objective comparison between a current recording and previous recordings. For example, the qualitative visual indication 512 associated with a recording may provide a baseline value that can be compared to other recordings”).
Regrading Claim 10, Witkowski teaches the method of claim 9,
Witkowski further teaches wherein calibrating the remote device based on the identified differences between the received Doppler sounds and (Witkowski, Figure 4, [0057], “AFE 340 may receive 1 µSec and 0.8 µSec pulses@ 78 KHz from processor 310, which are then sent to Doppler probes or transducers 106. Then, AFE 340 receives return signals (e.g., of a phase shift) from the transducers 106, which are converted to audio signals and sent to filter 342 and/or AMP 350. The audio signals represent a phase shift or a Doppler shift detected by monitor 150, which is converted into audio”) the received remote device sounds is accomplished using. sound equalization characterization techniques (Witkowski, Figure 4, [0059] “The audio signal may be digitally filtered to control background noise levels. In another example, filter module 342 may perform a fast Fourier transform (FFT) of the signal to divide the audio signal into multiple frequency components that are digitally filtered. The digital filtering may include applying a bandpass (low and high) filter and a signal boost (e.g., a boost of 236Hz”).
Regrading Claim 11, Witkowski teaches the method of claim 9,
Witkowski further teaches wherein the blood vessel is a vein. (Witkowski, [0073] “For instance, various aspects concerning blood flow within a vessel can be monitored and recorded”).
Regrading Claim 12, Witkowski teaches the method of claim 9,
Witkowski further teaches wherein the blood vessel is an artery. (Witkowski, Figures1B, [0035] “The vascular coupler formed by the pair of fasteners 104 is adapted to create an end-to-end anastomosis of a blood vessel (e.g., a vein or artery) while retaining and maintaining the position of the transducer(s) 106 or other sensing device(s). The sensing devices, in turn, can be used to monitor or evaluate parameters associated with recovery and success of the surgical procedure, such as blood flow at an anastomotic site to confirm vessel patency”).
Regrading Claim 13, Witkowski teaches the method of claim 9,
Witkowski further teaches wherein receiving the Doppler sounds relating to the blood flow through the blood vessel as received Doppler sounds using the microphone of the remote device is accomplished such that the received Doppler sounds are saved locally to the remote device. (Witkowski, Figures 4-5 [0062] Monitor 150 may communicate with a cloud computing infrastructure 480 (e.g., Amazon Web Services ("AWS")), which may include a backend server 482 (e.g. backend AWS Elastic Compute Cloud ("EC2") server), an audio server 484, a database search tool (e.g., Mongo DB), and a database 488 (e.g., Amazon Simple Storage Service ("S3"). [0064], “the user device 402 may communicate with the backend server 482 and the database 488 to play audio file 490”).
Regrading Claim 14, Witkowski teaches the method of claim 9,
Witkowski further teaches wherein receiving the remote device sounds using the microphone of the remote device is accomplished such that the received remote device sounds are saved locally to the remote device. (Witkowski, Figure 5, [0070] For example, as illustrated in FIG. 6, a medical practitioner (e.g., surgeon) may select the graphical representation of the "Request-Current" button 502 to listen to a "current recording" of the blood flow at the anastomotic site. In an example, selecting the "Request-Current" button 502 may initiate a recording and thus may not be a real-time audio signal of the blood flow, but instead may be delayed by a brief period (e.g., 10 seconds, 15 seconds, 20 seconds, etc.). For example, by selecting button 502, a 15 second recording of the audio signal of the patient's blood flow may be recorded and uploaded to database 488, which may then be retrieved and played by user device 402 to provide an audible indication of
blood flow via speakers of user device 402. The application may also allow a medical practitioner (e.g., surgeon) to play, listen to and review previous audio recordings for that patient. For example, by selecting any of the graphical representations of the "Previous Recording_ l ", "Previous Recording_ 2", or "Previous Recording_ 3" buttons 5 04, 5 06 or 508 respectively, the medical practitioner (e.g., surgeon) may listen to previous recordings of the audio signal of the patient's blood flow. By doing so, the surgeon may be able to compare the audio signals and determine if the patient's blood flow is improving,
worsening or staying approximately the same” NOTE: Examiner interpreted “remote device” as any device in communication with the “doppler monitor” where doppler sound data stored or can be retrieved from. It is to note that the instant application specification refers in [0025] “remote device” as one of cellular phone, computers or cloud computing e.g., directly, through a cloud computing resource that the remote device can access) such that a clinician can view the patient data using the remote device (e.g., listen to Doppler sounds, view data”).
Regrading Claim 15, Witkowski teaches the method of claim 9,
Witkowski further teaches wherein the remote device has a visual display field; and wherein the blood flow monitor has a visual display field. (Witkowski, Figure 6, 512, [0072] “In another example, the application may provide a qualitative visual indication 512 of blood flow. the visual indication 512 may include various bars that each represent a frequency range or blood flow velocity threshold. Qualitative visual indication 512 of the application on user device 402 may be able to indicate blood flow velocities as low as 0.5 cm/s or 0.75 cm/s and as high as 45 cm/s.”).
Regrading Claim 16, Witkowski teaches the method of claim 15,
Witkowski further teaches further comprising displaying data relating to the blood flow through the blood vessel on the visual display field of the blood flow monitor (Witkowski, Figure 2, 212, [0054] As illustrated in FIG. 2, the display or user interface 210 provides a qualitative visual indication 212 of blood flow. In an example, the visual indication 212 may include various bars that each represent a frequency range or blood flow velocity threshold. For example, visual indication
212 of monitor 150 may be able to indicate blood flow velocities as low as 0.5 cm/s or 0.75 crn/s and may also be able to indicate blood flow velocities as high as 45 crn/s”); and
further comprising displaying data relating to the blood flow through the blood vessel on the visual display field of the remote device. (Witkowski, Figure 6, 512, [0072] “In another example, the application may provide a qualitative visual indication 512 of blood flow. the visual indication 512 may include various bars that each represent a frequency range or blood flow velocity threshold. Qualitative visual indication 512 of the application on user device 402 may be able to indicate blood flow velocities as low as 0.5 cm/s or 0.75 cm/s and as high as 45 cm/s.”).
Conclusion
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cahan et al. (US 2017 /0224279 A1) recites “ A system and method for monitoring a health status of a subject. The system comprises: a medical device implantable in the subject and having a passage or compartment through which blood flows through; a sensor device embedded at or near a surface of said passage within said medical device for generating signals suitable for measuring a Doppler shift effect occurring within said passage; and a control device coupled to said sensor device for measuring a liquid blood flow rate within said passage based on sensor generated signals outputs. The embedded sensor device comprises a first piezo-electric element configured to generate an acoustic excitation signal and a second piezo-electric element configured to receive said acoustic excitation signal. The second piezo-electric element emits a signal responsive to said acoustic excitation signal. Control device in real time compares a generated output signal with the input excitation signal to determine a Doppler frequency shift measurement” (Abstract).
Kuraguntla et al. (US 20140214149 A1) recites A prosthesis for monitoring a characteristic of flow includes a first tubular prosthesis having a lumen and a sensor for detecting the characteristic of flow through the lumen. The sensor may be covered with another tubular prosthesis or by a layer of material in order to insulate the sensor from the fluid flow. A pocket may be formed between the tubular prosthesis and the adjacent layer of material or prosthesis and the sensor may be disposed in the pocket.” (Abstract)
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supervisor, EMAN ALKAFAWI can be reached on (571) 272-4448. 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.
/DILARA SULTANA/Examiner, Art Unit 2858
/EMAN A ALKAFAWI/Supervisory Patent Examiner, Art Unit 2858 1/9/2026