DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Claims 8-21 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 22 June 2026.
Applicant’s election without traverse of Group I: claims 2-7 in the reply filed on 22 June 2026 is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 12 November 2025, 18 April 2025, 09 October 2024, and 27 June 2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 61/226996, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. For example, there is inadequate support for “an anchor configured to adhesively secure to skin at or near the neck or a shoulder of the subject and further configured to secure to a portion of the second cable” in claim 2. Accordingly, claims 2-7 are not entitled to the benefit of the prior application. It appears that Application No. 61/350673 (filing date: 06/02/2010) to which the instant application claims benefit to has adequate support for the limitation, and thus the priority date of the application will be 06/02/2010.
Response to Amendment
This Office Action is responsive to the amendment filed 22 June 2026. As per the amendment: claims 8-21 have been withdrawn, claim 1 remains as previously cancelled, and no new claims have been added, cancelled, or amended. Thus claims 2-7 are presently pending and under examination.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-5 and 7 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Moon et al. (US 2010/029865 A1), hereinafter Moon in view of Banet et al. (US 2009/0018409 A1), hereinafter Banet.
Regarding claim 2, Moon discloses a patient monitoring system (Figure 3A-3B, Abstract: “a system and method for measuring vital signs”), comprising:
an optical sensor (optical sensor 94, optical system 18) configured to be secured to a finger of a subject (view Figure 3A-3B, [0059] “optical sensor 94 that wraps around the base of the patient's thumb”), the optical sensor comprising at least one emitter configured to emit light into tissue of the subject's finger and at least one detector configured to detect at least a portion of said emitted light after attenuation by said tissue ([0053] “The optical system 18 features an LED and photodetector”) , the optical sensor configured to generate one or more signals indicative of at least one blood parameter of the subject ([0056] “The optical system generates a PPG 52 using an infrared LED and matched photodetector incorporated into an optical sensor that attaches to the base of the patient's thumb.”, [0105] “An optical sensor attached to the patient's thumb measures PPG waveforms”);
an acoustic sensor ([0012] acoustic sensor)
an electrocardiogram (ECG) sensor (ECG electrodes 78a-c) configured to be secured to a chest of the subject and comprising a plurality of leads, the ECG sensor configured to generate one or more signals responsive to electrical activity of a heart of the subject (Figure 3A-3B, [0063] “The ECG electrodes 78a-c are typically disposed in a conventional `Einthoven's Triangle` configuration which is a triangle-like orientation of the electrodes 78a-c on the patient's chest that features three unique ECG vectors.”, [0021]);
a strap (flexible strap 90) configured to secure around a portion of an arm of the subject ([0066] “it attaches to the patient's wrist using a flexible strap 90”);
a monitoring device (transceiver 72, transceiver 12) configured to be secured to the subject's arm via said strap (Figure 3A and 4, [0066] “the wrist-worn transceiver 72. As described above, it attaches to the patient's wrist using a flexible strap 90 which threads through two D-ring openings in a plastic housing 106.”), the monitoring device comprising a display ([0066] “The transceiver 72 features a touchpanel display 100 that renders a graphical user interface 73 which is altered depending on the viewer (typically the patient or a medical professional).”) and further configured for wireless communication with an external device ([0055] “the transceiver 12 uses an internal wireless transmitter 24 to send information in a series of packets, as indicated by arrow 34, to a central nursing station within a hospital.” , View Figure 1);
a first cable (cable 92), the first cable connecting the optical sensor to the monitoring device ([0059] “A cable 92 connects an optical sensor 94 that wraps around the base of the patient's thumb to the transceiver 72.”) and configured to transmit said one or more signals indicative of said at least one blood parameter from the optical sensor to the monitoring device ([0051] “he transceiver 12 also connects to an ECG system 16 that measures an ECG waveform, an optical system 18 that measures a PPG waveform, and a pneumatic system 20 for making cuff-based `indexing` blood pressure measurements according to the composite technique. Collectively, these systems 14a-c, 16, 18, and 20 continuously measure the patient's vital signs and motion.”, [0059]);
a second cable (cable 82)
wherein said monitoring device is configured to:
receive said one or more signals indicative of said at least one blood parameter generated by said optical sensor, and said one or more signals responsive to said electrical activity of the subject's heart ([0053] “The optical system 18 features an LED and photodetector and, unlike the ECG 16 and pneumatic 20 systems, generates an analog electrical signal that connects through a cable 36 and connector 26 to the transceiver 12”, [0063] “From these electrical signals the ECG circuit determines up to three ECG waveforms, which are digitized using an analog-to-digital converter mounted proximal to the ECG circuit, and sent through a cable 82 to the wrist-worn transceiver 72 according to the CAN protocol.”, [0059] “A cable 92 connects an optical sensor 94 that wraps around the base of the patient's thumb to the transceiver 72. During a measurement, the optical sensor 94 generates a time-dependent PPG, similar to the waveform 52 shown in FIG. 2, which is processed along with an ECG to measure blood pressure.”) ;
output, via said display, information representative of said at least one blood parameter, said at least one respiratory parameter, and said electrical activity ([0066] “The transceiver 72 features a touchpanel display 100 that renders a graphical user interface 73 which is altered depending on the viewer (typically the patient or a medical professional)…the user interface 73 displays vital sign data and other medical diagnostic information appropriate for medical professionals. Using this interface 73, the nurse or doctor, for example, can view the vital sign information, set alarm parameters, and enter information about the patient (e.g. their demographic information, medication, or medical condition).”, [0109] “a technique for rolling averages can be deployed, allowing values for cNIBP (step 220), HR and TEMP (step 226), RR (step 224), and SpO2 (step 222) to be displayed every second.); and
wirelessly transmit said information representative of said at least one blood parameter, said at least one respiratory parameter, and said electrical activity to the external device ([0055] “the transceiver 12 uses an internal wireless transmitter 24 to send information in a series of packets, as indicated by arrow 34, to a central nursing station within a hospital.” , View Figure 1).
Moon fails to explicitly disclose an acoustic sensor configured to be secured to a portion of a neck of the subject, the acoustic sensor configured to generate one or more signals indicative of at least one respiratory parameter of the subject; the second cable connecting the acoustic sensor to the monitoring device and configured to transmit said one or more signals indicative of said at least one respiratory parameter from the acoustic sensor to the monitoring device; and an anchor configured to adhesively secure to skin at or near the neck or a shoulder of the subject and further configured to secure to a portion of the second cable; and receiving, outputting, and transmitting said one or more signals indicative of said at least one respiratory parameter generated by said acoustic sensor.
Banet teaches medical devices for monitoring respiratory rate and other vital signs ([0002]) an acoustic sensor (acoustic sensor 6) configured to be secured to a portion of a neck of the subject ([0008] “The acoustic sensor is typically placed near the patient's trachea”), the acoustic sensor configured to generate one or more signals indicative of at least one respiratory parameter of the subject ([0033] “The sensor 6 is preferably a small-scale microphone that senses `sounds` associated with the patient's breathing, resulting in a time-dependent acoustic waveform 4, shown graphically in FIG. 2. The acoustic waveform 4 features a `packet` 9 associated with each breath that includes first 9a and second 9b signals corresponding, respectively, to inspiration and expiration.”, [0008] “The acoustic sensor measures respiration rate by recording sounds related to the patient's inspiration and expiration.”) the second cable (cable 51a) connecting the acoustic sensor to the monitoring device and configured to transmit said one or more signals indicative of said at least one respiratory parameter from the acoustic sensor to the monitoring device ([0033] “To determine respiratory rate, the acoustic sensor 6 detects an analog signal, which passes through a cable 51a to a body-worn unit described in detail below with reference to FIG. 4.”); and an anchor configured to adhesively secure to skin at or near the neck or a shoulder of the subject and further configured to secure to a portion of the second cable ([0033] “a patch sensor 42a that includes both an acoustic sensor 6 and electrode 7 for measuring respiration rate and electrical signals which can be used to determine other vital signs (e.g. heart rate). A foam backing 5 supports both components within the patch sensor 42a, which additionally includes an adhesive layer 8 on its opposing side.”, view Figure 1A and 4); and receiving, outputting, and transmitting said one or more signals indicative of said at least one respiratory parameter generated by said acoustic sensor ([0033] “To determine respiratory rate, the acoustic sensor 6 detects an analog signal, which passes through a cable 51a to a body-worn unit described in detail below with reference to FIG. 4. The body-worn unit includes an analog-to-digital converter and microprocessor that, collectively, digitize and analyze the acoustic waveform 4 to determine the number of packets 9 during a short time period (e.g., 1 minute). This corresponds to the patient's breathing rate (typically expressed in breaths/minute).”, [0045] “At a predetermined interval (typically, every few minutes) the body-worn unit transmits this information through a short-range wireless interface 12 (e.g., a Bluetooth.RTM. interface) to the bedside device 10.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moon to incorporate the teachings of Banet to have an acoustic sensor configured to be secured to a portion of a neck of the subject, the acoustic sensor configured to generate one or more signals indicative of at least one respiratory parameter of the subject; the second cable connecting the acoustic sensor to the monitoring device and configured to transmit said one or more signals indicative of said at least one respiratory parameter from the acoustic sensor to the monitoring device; and an anchor configured to adhesively secure to skin at or near the neck or a shoulder of the subject and further configured to secure to a portion of the second cable; and receiving, outputting, and transmitting said one or more signals indicative of said at least one respiratory parameter generated by said acoustic sensor, as these prior art references and the instant application are directed to patient monitoring devices. One would be motivated to do this as respiratory rate is an essential parameter in diagnosing disorders and an attached acoustic sensor allows for long term monitoring, as recognized by Banet ([0003]).
Regarding claim 3, Moon in view of Banet teaches the patient monitoring system of claim 2 (as shown above). Moon further discloses wherein said at least one blood parameter of the subject comprises oxygen saturation ([0051] “a body-worn vital sign monitor 10 according to the invention featuring a wrist-worn transceiver 12 that continuously determines vital signs (e.g. SYS, DIA, SpO2, heart rate, respiratory rate, and temperature)”, [0108] “SpO2 is measured according to step 222 with the body-worn vital sign monitor using an integrated reference hardware design, algorithm”, [0006] “During a measurement, a microprocessor analyses both red and infrared radiation detected by the photodetector to determine the patient's blood oxygen saturation level and a time-dependent waveform called a photoplethysmograph (`PPG`).”) .
Regarding claim 4, Moon in view of Banet teaches the patient monitoring system of Claim 2 (as shown above). Moon further discloses wherein said at least one respiratory parameter of the subject comprises respiratory rate ([0051] “a body-worn vital sign monitor 10 according to the invention featuring a wrist-worn transceiver 12 that continuously determines vital signs (e.g. SYS, DIA, SpO2, heart rate, respiratory rate, and temperature)”, [0063] “Heart rate and respiratory rate are determined directly from the ECG waveform using known algorithms,”) .
Regarding claim 5, Moon in view of Banet teaches the patient monitoring system of Claim 2 (as shown above). Moon further discloses wherein said plurality of leads comprises two leads ([0065] “More sophisticated ECG circuits can plug into the wrist-worn transceiver to replace the three-lead system shown in FIGS. 3A and 3B. These ECG circuits can include, e.g., five and twelve leads…”, Figure 3A-3B)
Regarding claim 7, Moon in view of Banet teaches the patient monitoring system of Claim 2 (as shown above). Moon further discloses wherein said strap is an inflatable blood pressure cuff (cuff 84, [0061] “inflates a disposable cuff 84”), and wherein said monitoring device is configured to measuring blood pressure of the subject ([0061]-[0062] “The cuff 84 within the cuff-based pneumatic system 85 is typically disposable and features an internal, airtight bladder that wraps around the patient's bicep to deliver a uniform pressure field. During the indexing measurement, pressure values are digitized by the internal analog-to-digital converter, and sent through a cable 86 according to the CAN protocol, along with SYS, DIA, and MAP blood pressures, to the wrist-worn transceiver 72 for processing as described above.”).
Alternatively, Banet teaches wherein said strap is an inflatable blood pressure cuff ([0042], view Figure 4), and wherein said monitoring device is configured to measuring blood pressure of the subject ([0042] “The microprocessor in the body-worn sensor then analyzes the optical waveform according to the algorithm in the above-mentioned patent application to determine the patient's blood pressure.”)
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moon to incorporate the teachings of Banet to have the strap be an inflatable blood pressure cuff, and wherein said monitoring device is configured to measure blood pressure of the subject, as these prior art references and the instant application are directed to wearable patient monitoring devices. One would be motivated to do this to be able to monitor health of a patient.
Claim 6 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Moon in view of Banet as applied to claim 2 above, and further in view of Otto et al. (US 2009/0069724 A1), hereinafter Otto.
Regarding claim 6, Moon in view of Banet teaches the patient monitoring system of Claim 2 (as shown above). Moon and Banet, alone or in combination, fail to explicitly teach wherein said monitoring device is detachable from said strap.
However, Otto teaches a wearable health monitoring device for physiological health monitoring (Abstract, [0001]) wherein said monitoring device is detachable from said strap ([0028] “The wearable health monitoring device 100 comprises a controller housing 103 and a strap 101, e.g., an elastic strap. The controller housing 103 attaches to the strap 101 with two or more electrode snaps 104. The snaps 104 serve a dual purpose to both attach and secure as well as provide electrical connection to the elastic strap's electrodes, which is described further herein with reference to FIG. 2.”, [0031]).
It would have been prima facie obvious for one ordinary skill in the art before the effective filing date of the claimed invention to have modified Moon and Banet to incorporate the teachings of Otto to have the monitoring device be detachable from said strap, as these prior art reference are directed to health monitoring device. One would be motivated to do this to be able to be have a separable monitoring device for transporting or cleaning.
Examiner would also like to note that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the monitoring device be detachable from said strap, since it has been held that making a structure separable was a matter of choice one of ordinary skill in the art would have found obvious due desirable effects such as an increase in accessibility for transportation or cleaning. See MPEP 2144.04 V. (C) In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961). Additionally, the present disclosure has not criticality for having the monitoring device be detachable or fully incorporate into said strap.
Claim 6 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Moon in view of Banet as applied to claim 2 above, and further in view of Moon et al. (US Patent 10,420,476 B2), hereinafter Moon’476.
Regarding claim 6, Moon in view of Banet teaches the patient monitoring system of Claim 2 (as shown above). Moon and Banet, alone or in combination, fail to explicitly teach wherein said monitoring device is detachable from said strap.
However, Moon’476 teaches a body-worn monitor featuring a processing system that receives a digital data stream from an ECG system (Abstract) wherein said monitoring device is detachable from said strap (Column 16, lines 20-22: “the transceiver 72 is simply detached from the plastic housing 106 and then cleaned.”)
It would have been prima facie obvious for one ordinary skill in the art before the effective filing date of the claimed invention to have modified Moon and Banet to incorporate the teachings of Moon’476 to have the monitoring device be detachable from said strap, as these prior art reference are directed to health monitoring device. One would be motivated to do this to be able to clean the device, as recognized by Moon’476 (Column 16, lines 20-22).
Examiner would also like to note that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the monitoring device be detachable from said strap, since it has been held that making a structure separable was a matter of choice one of ordinary skill in the art would have found obvious due desirable effects such as an increase in accessibility for transportation or cleaning. See MPEP 2144.04 V. (C) In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961). Additionally, the present disclosure has not criticality for having the monitoring device be detachable or fully incorporate into said strap.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ATTIYA SAYYADA HUSSAINI whose telephone number is (703)756-5921. The examiner can normally be reached Monday-Friday 8:00 am - 5:00 pm.
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/ATTIYA SAYYADA HUSSAINI/ Examiner, Art Unit 3792
/NIKETA PATEL/ Supervisory Patent Examiner, Art Unit 3792
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