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 .
Response to Amendment
This office action is responsive to the amendment filed on 3/11/2026. As directed by the amendment, the status of the claim(s) are:
Claim(s) 1-3 has/have been amended;
Claim(s) 1-14 is/are presently pending.
Response to Arguments
With regard to claim rejections under 35 USC 102 and/or 103, Applicant’s arguments have been fully considered but are moot in light of new grounds of rejection due to claim amendment(s). See new grounds of rejection of amended independent claim 1 and its dependents below.
Applicant argues on p. 11 of remarks that the prior art rejection under 103 of claims 11-13 are insufficient because there is no explanation of why a person of ordinary skill in the art would modify the telemetry architecture of Flores to incorporate the multi-lead diagnostic system of Segalowitz and that the additional rationale of duplication of parts is inapplicable because the number of electrodes fundamentally changes the monitoring capability and processing requirements of the system. After review, this is not persuasive. Both Flores and Segalowitz teach wireless ECG monitoring with wireless ECG electrodes, further both references teach that wireless electrodes are better than traditional wired ECG electrodes in which the references specifically discuss the number of electrodes (Flores [0002] “typically three, five or twelve sensors”; [009] “wireless ECG patient telemetry…permits mobility of the patient…would be novel and useful”; Segalowitz Col. 2 lines 5-20 “standard electrocardiograph requires at least 10 wires to be attached to the body…After the ten electrodes are attached to the patient…Many and frequency difficulties exist…”; Col. 2 lines 30-35 “Often, the 10 terminal wires become intertangled with each other and it takes precious time to get them untangled”; Col. 2 lines 65-68 “It is a further object of this invention to provide electrocardiographic and rhythm monitoring systems in which the physical wires between the patient and the electrocardiograph or monitor are eliminated”). Thus, a person of ordinary skill in the art reading this would conclude that wireless electrodes are to be substituted for the traditional wired ECG electrodes, and as discussed by Segalowitz, there is a ECG measurement in which 10 are used and the use of wireless enables easier monitoring because physical wires which can become intertangled are eliminated.
As for duplication of parts rationale, as discussed above, the prior art teaches that it is known that different numbers of electrodes can be used for ECG monitoring. Thus, a person of ordinary skill in the art would consider modifying the number of electrodes such as by adding more electrodes to be an obvious duplication of parts since each electrode structure is the same as the other and it is known in the art that different electrodes are to be placed in various locations on the body for ECG monitoring. The prior art contemplates and discusses different numbers of electrodes and their configurations and so modifying the number of electrodes would not change the functions of the prior art ECG monitoring system with new and unexpected result(s).
Applicant argues on p. 12 regarding 103 rejection of claim 14. Applicant argues that the cited reference address different technological systems and design objectives and there is no articulation for why a person of ordinary skill in the art would modify Flores and Segalowitz to incorporate the hospital information network architecture of Brinsfield. After review this is not persuasive because all references are within the same field of endeavor of monitoring physiological data, specifically ECG from patient and wirelessly sending data to a monitor. Brinsfield was relied upon to teach what was missing from Flores and Segalowitz, e.g. hospital communications architecture, and specifically suggests that ECG data is to be used for such monitoring in hospital ([0003] “ECG”; [0007] “The present invention provides a system and method of offering two-way, remote, mobile clinical care to patients…that solves the aforementioned problems”).
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 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, 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crawford (US 20110125040 A1; 5/26/2011) in view of Flores (US 20090099469 A1; 4/16/2009; cited in previous office action).
Regarding claim 1, Crawford teaches a medical monitoring device (Fig. 1; Fig. 12) comprising:
a portable monitoring unit (Fig. 1; Fig. 7; Fig. 8b), the monitoring unit comprising a processor, a wireless transceiver in data communication with the processor, and a power supply in electrical communication with the processor and the receiver (Fig. 7; Fig. 8b; Fig. 8d-8f; Fig. 12a-13).
Crawford teaches wireless electrode patch with multiple electrodes with tramsitter in electrical communication with the electrode, a power supply in electrical communication with the transmitter, and an adhesive operably connected to the electrode (Fig. 2; Fig. 8a-12; [0050]).
Crawford does not explicitly teach a plurality of wireless electrodes, each of the wireless electrode comprising an electrode, a transmitter in electrical communication with the electrode, a power supply in electrical communication with the transmitter, and an adhesive operably connected to the electrode (interpreted as multiple wireless devices each having an electrode and the other recited elements). However, Flores teaches in the same field of endeavor (Abstract) a plurality of wireless electrodes, each of the wireless electrode comprising an electrode (Fig. 1-2; [0011]), a transmitter in electrical communication with the electrode ([0012]), a power supply in electrical communication with the transmitter ([0012]), and an adhesive operably connected to the electrode ([0013]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Crawford to include these features as taught by Flores because this enables having multiple wireless electrode devices for placement as needed/desired (Fig. 1; [0002]; [0009]; [0026]); this is also an obvious duplication of parts/making separable by having multiple wireless electrodes instead of a single wireless patch with multiple electrodes; MPEP 2144.04.
The combination of Crawford and Flores teaches wherein the portable monitoring unit is configured to simultaneously receive physiological signals from each of the plurality of wireless electrodes and generate and display a multi-lead electrocardiogram representation based on the received signals (Crawford Fig. 8b; Fig. 28; [0050]; [0056]; Flores Fig. 2).
Regarding claim 4, the combination of Crawford and Flores teaches a display in data communication with the monitoring unit (Crawford Fig. 7-8i; Fig. 13-14; Fig. 28; Flores Fig. 2; [0014]; claim 1).
Regarding claim 5, the combination of Crawford and Flores teaches each of the wireless electrodes detect an electrocardiogram signal (ECG) from electrical activity of a patient's heart when attached to a patient (Crawford Fig. 7-8i; Fig. 13-14; Fig. 28; [0050]; [0056]; Flores Fig. 2; [0012]-[0014]; claim 1); and
the monitoring unit is programmed and configured to receive the ECG signal from each of the wireless electrodes and transmit each of the ECG signals to the display (Crawford Fig. 7-8i; Fig. 13-14; Fig. 28; [0050]; [0056]; Flores Fig. 2; [0012]-[0014]; claim 1).
Regarding claim 6, the combination of Crawford and Flores teaches wherein the ECG signals are displayed on the monitor in real time relative to when they are detected by the wireless electrodes (Crawford Fig. 8b-8c; [0056] “streamed to the display and shown in real time”).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crawford and Flores as applied to claim(s) 1 above, and further in view of Segalowitz (US 4981141 A; 1/1/1991; cited in previous office action).
Regarding claim 2, the combination of Crawford and Flores does not teach wherein the plurality of wireless electrodes comprises 10 wireless electrodes. However, Segalowitz teaches in the same field of endeavor (Abstract; Fig. 1) wherein the plurality of wireless electrodes comprises 10 wireless electrodes (Col. 2 lines 5-20; Col. 2 lines 30-35; Col. 2 lines 65-68; the reference is teaching that wireless electrode can replace the ten wired electrodes). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Crawford and Flores to include these features as taught by Segalowitz because this enables easier monitoring (Col. 2 lines 5-20; Col. 2 lines 30-35; Col. 2 lines 65-68).
The combination of Crawford, Flores, and Segalowitz teaches the portable monitoring unit configured to generate a multi-lead electrocardiogram (Crawford Fig. 8b; Fig. 28; [0050]; [0056]; Flores Fig. 2; Segalowitz Fig. 1).
Regarding claim 3, the combination of Crawford and Flores does not teach wherein the plurality of wireless electrodes comprises 12 wireless electrodes, the portable monitoring unit configured to generate a 12-lead electrocardiogram. Note that Flores teaches ECG monitoring typically receives from twelve sensors ([0002]). However, Segalowitz teaches in the same field of endeavor (Abstract; Fig. 1) wherein the plurality of wireless electrodes comprises 12 wireless electrodes (Col. 1 lines 45-46 “12-lead”; Col. 2 lines 5-20 “at least 10 wires”; Col. 2 lines 30-35; Col. 2 lines 65-68; the reference is teaching that wireless electrode can replace the wired electrodes). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Crawford and Flores to include these features as taught by Segalowitz because this enables easier monitoring (Col. 2 lines 5-20; Col. 2 lines 30-35; Col. 2 lines 65-68).
The combination of Crawford, Flores, and Segalowitz teaches the portable monitoring unit configured to generate a 12-lead electrocardiogram (Crawford Fig. 8b; Fig. 28; [0050]; [0056]; Flores Fig. 2; Segalowitz Fig. 1; the modified combination of reference takes in wireless data from the electrodes and displays the lead channel as appropriate and so would generate 12-lead electrocardiogram when there are 12 electrodes).
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crawford and Flores as applied to claim(s) 5 above, and further in view of Brinsfield (US 20050192845 A1; 9/1/2005; cited in previous office action).
Regarding claim 7, the combination of Crawford and Flores does not explicitly teach the monitoring unit is in wireless data communication with an access point; and
the access point is in data communication with a hospital local area network (LAN). Note that Crawford teaches sending data to wireless server that can be accessed from hospital (Fig. 14; [0075]; [0084]).
However, Brinsfield teaches in the same field of endeavor ([0003]; [0020]) the monitoring unit is in wireless data communication with an access point (Fig. 2-3; [0009]; [0020]; [0022]); and
the access point is in data communication with a hospital local area network (LAN) (Fig. 2-3; [0009]; [0020]; [0022]).
Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Crawford and Flores to include these features as taught by Brinsfield because this enables convenient monitoring of patients (Fig. 2; [0007]; [0024]; [0028]).
Regarding claim 8, in the combination of Crawford, Flores, and Brinsfield, Brinsfield teaches wherein the LAN is in data communication with a hospital information management server (HIMS) and the monitoring device is programmed to communication the ECG signal to the HIMS ((Fig. 2-3; [0009]; [0020]; [0022]; [0028]).
Regarding claim 9, in the combination of Crawford, Flores, and Brinsfield, Brinsfield teaches wherein the monitoring unit is located in one room of a building and the display is located is a different room of the building (Fig. 2; [0022]; [0028]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crawford and Flores as applied to claim(s) 1 above, and further in view of Segalowitz (US 5511553 A; 4/30/1996), hereinafter Segalowitz ‘553.
Regarding claim 10, the combination of Crawford and Flores does not teach a wireless pulse oximeter, the pulse oximeter being in wireless communication with the monitoring unit. However, Segalowitz ‘553 teaches in the same field of endeavor (Abstract; Fig. 1A; Fig. 9; Col. 37 lines 5-40) teach a wireless pulse oximeter, the pulse oximeter being in wireless communication with the monitoring unit (Fig. 28; Fig. 39; Col. 12 lines 4-10). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Crawford and Flores to include these features as taught by Segalowitz ‘553 because this enables additional monitoring of blood oxygen (Fig. 28; Fig. 39; Col. 12 lines 4-10).
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flores (US 20090099469 A1; 4/16/2009; cited in previous office action) in view of Segalowitz (US 4981141 A; 1/1/1991; cited in previous office action).
Regarding claim 11, Flores teaches an electrocardiogram (ECG) monitoring device (Abstract) comprising:
a monitoring unit (Fig. 2), the monitoring unit comprising a processor, a transceiver in data communication with the processor (Fig. 2; [0014]; claim 1 “computer processor…display device”), and a power supply in electrical communication with the processor and the receiver (it is inherent that a computer/display device of Flores Fig. 2, [0014], and claim 1 would have power supply).
Flores does not teach at least 10 wireless electrodes. However, Segalowitz teaches in the same field of endeavor (Abstract; Fig. 1) at least 10 wireless electrodes (Col. 2 lines 5-20; Col. 2 lines 30-35; Col. 2 lines 65-68; the reference is teaching that wireless electrode can replace the ten wired electrodes). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Flores to include these features as taught by Segalowitz because this enables easier monitoring (Col. 2 lines 5-20; Col. 2 lines 30-35; Col. 2 lines 65-68). In addition, this would be an obvious duplication of parts; MPEP 2144.04.
In the combination of Flores and Segalowitz, Flores teaches each of the wireless electrode comprising an electrode (Fig. 1-2; [0011]), a transmitter in electrical communication with the electrode ([0012]), a power supply in electrical communication with the transmitter ([0012]), and an adhesive operably connected to the electrode ([0013]).
Regarding claim 12, Flores teaches a method of generating an electrocardiogram (ECG) (Abstract), the method comprising:
detecting ECG signals through a plurality of wireless electrodes (Fig. 2; [0011]-[0013]).
Flores does not teach at least 10 ECG signals. However, Segalowitz teaches in the same field of endeavor (Abstract; Fig. 1) at least 10 wireless ECG electrodes (Col. 2 lines 5-20; Col. 2 lines 30-35; Col. 2 lines 65-68; the reference is teaching that wireless electrode can replace the ten wired electrodes). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Flores to include these features as taught by Segalowitz because this enables easier monitoring (Col. 2 lines 5-20; Col. 2 lines 30-35; Col. 2 lines 65-68). In addition, this would be an obvious duplication of parts; MPEP 2144.04.
The combination of Flores and Segalowitz teaches wirelessly transmitting each of the at least 10 ECG signals from the electrodes to a monitoring unit (Flores Fig. 2; [0014]; claim 1 “computer processor…display device”; Segalowitz Fig. 1) and
displaying each of the at least 10 wireless signals on a display in real time (Flores Fig. 2; [0014]; claim 1 “computer processor…display device”; Segalowitz Fig. 1; Col. 3 lines 1-15 “real time”).
Regarding claim 13, the combination of Flores and Segalowitz teaches wherein displaying each of the at least 10 wireless signal comprises wireless transmitting the ECG signals from the monitoring unit (Flores Fig. 2; [0012]-[0014]; claim 1; Segalowitz Fig. 1; Col. 3 lines 1-15).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flores and Segalowitz as applied to claim(s) 13 above, and further in view of Brinsfield (US 20050192845 A1; 9/1/2005; cited in previous office action).
Regarding claim 14, the combination of Flores and Segalowitz does not teach wherein the monitoring unit is in data communication with a local area network, and displaying each of the at least 10 wireless signal comprises transmitting the ECG signals from the monitoring unit, through an access point, and to the display. However, Brinsfield teaches in the same field of endeavor ([0003]; [0020]) the monitoring unit is in data communication with a local area network (Fig. 2-3; [0009]; [0020]; [0022]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Flores and Segalowitz to include these features as taught by Brinsfield because this enables convenient monitoring of patients (Fig. 2; [0007]; [0024]; [0028]).
The combination of Flores, Segalowitz, and Brinsfield teaches displaying each of the at least 10 wireless signal comprises transmitting the ECG signals from the monitoring unit, through an access point, and to the display (Flores Fig. 2; [0012]-[0014]; claim 1; Segalowitz Fig. 1; Col. 3 lines 1-15; Brinsfield Fig. 2; [0007]; [0024]; [0028]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/ Primary Examiner, Art Unit 3792