DETAILED ACTION
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 Election/Restriction Filed
The Applicant filed Response to Election/Restriction on August 12, 2026 in response to the Examiner’s Requirement for Election/Restriction, mailed June 22, 2026.
Election
Applicant's election of Group IV, as depicted by Fig. 6, in the reply filed on August 12, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Applicant further indicated that claims 9, 13-16, 18, 20-22, and 28 correspond to the elected group. However, it is noted that claims 20-22 are dependent on non-elected claim 19, therefore, these claims would not be part of the elected Group IV. Additionally, claim 28 is dependent on non-elected claim 24, therefore, this claim would not be part of the elected Group IV.
Status of the Claims
At this time, claims 9-28 are pending. Claims 9, 13-16, and 18 currently under consideration, and claims 10-12, 17, and 19-28 are withdrawn from consideration.
Drawings
Figure 7 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Paragraph [0004] of the instant Specification indicates that Fig. 7 is from the prior art labeled “Non Patent Literature 1”.
Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The claimed limitation of "magnetism" in claim 15 is not disclosed in the as-filed specification.
Claim Objections
Claims 14-16 are objected to because of the following informalities: The limitations “transmits” and “receives” should be amended to --configure to transmit-- and --configured to receive--, respectively, to ensure active functional limitations do not imply inclusion of human body being attached to the electrode devices. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9, 13-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 9, the antecedent basis of the limitation “plurality of electrode devices” in line 7 seems indefinite as it is unclear if “plurality of electrode devices” in line 7 is referring to the first occurrence of this term (“a plurality of electrode devices” in line 2). For the purpose of examination, the limitation “plurality of electrode devices” in line 7 has been interpreted as --the plurality of electrode devices--. All dependent claims 13-16 are also indefinite for the same reasons set forth for claim 9.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 9, 13, 14, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Liang et al. (WO 2020/224493, hereinafter referred to as Liang) in view of Toth et al. (US 2015/0335288, hereinafter “Toth”). For the purpose of prior art rejections in this Office action, US 2021/0244337 has been used as an English-equivalent document of WO 2020/224493.
Regarding independent claim 9, Liang discloses an electrocardiograph acquisition circuit, device, method and system. Liang further discloses a biosignal measurement system (“electrocardiograph acquisition system” in Figs. 1-9 and [0053]) comprising:
a plurality of electrode devices ([0054]: “…first electrocardiograph acquisition device (i.e., a master device)…”; [0071]: “…second electrocardiograph acquisition device (i.e., a slave device)…”; Figs. 1 and 2), each including an electrode (electrocardiograph electrode 101 in Fig. 1 and electrocardiograph electrode 201 in Fig. 2), an amplifier ([0114]: Fig. 5 depicts “differential circuit 132 may include two first-stage differential amplifiers A1 and one second-stage differential amplifier A2.”) configured to amplify a biopotential measured via the electrode ([0105]: “Since the directly used electrocardiographic voltage is small, amplification can be achieved by differentiation. Thus, the signal magnitude meets the demands of subsequent signal processing”), a quantization circuit (analog-to-digital converter 122 in Fig. 3, a component of acquisition circuit 102 in Fig. 1 and 3) configured to convert the biopotential into digital data to generate biopotential information ([0087]: “The acquisition circuit 102 includes a front-end circuit 121 and an analog-to-digital converter 122. The front-end circuit 121 is configured to convert a current signal detected by the electrocardiograph electrode 101 into an analog voltage signal. The analog-to-digital converter 122 is configured to obtain a digital voltage signal (i.e., the above second electrocardiographic voltage) by periodically sampling the analog voltage signal output by the front-end circuit 121 under the control of the clock signal.”), and a wireless transmitter (wireless transmission circuit 100 in Fig. 1 and wireless transmission circuit 200 in Fig. 2) configured to transmit the biopotential information (wireless transmission circuit 100 in Fig. 1 and wireless transmission circuit 200 in Fig. 2); and
a biosignal generation device (control circuit(s) 103, 203 in Figs. 1-3) including a wireless receiver ([0147]: “Since the signal between the electrocardiograph acquisition devices is transmitted wirelessly, there is no need to arrange a connection line on the electrocardiograph acquisition device.”) configured to receive the biopotential information ([0106]: “electrocardiographic voltages”) transmitted from plurality of electrode devices ([0106]: “In the scenario where more than two second electrocardiograph acquisition devices are configured, the control circuit can receive a plurality of first electrocardiographic signals, that is, the control circuit may obtain a plurality of first electrocardiographic voltages.”), and an arithmetic circuit (acquisition circuit 102, 201 in Figs. 1-3) configured to generate a biosignal waveform ([0126]: “The control circuit 203 is configured to generate the first electrocardiographic signal based on the first electrocardiographic voltage obtained by the acquisition circuit 201. The first electrocardiographic signal includes the first electrocardiographic voltage and the third acquisition time of the first electrocardiographic voltage.”) using the biopotential information obtained in at least two of the plurality of electrode devices ([0058]: “The control circuit 103 is configured to obtain an electrocardiograph index signal by processing the first electrocardiographic voltage received by the wireless transmission circuit 100 and the second electrocardiographic voltage acquired by the acquisition circuit 102 based on a first acquisition time of the first electrocardiographic voltage and a second acquisition time of the second electrocardiographic voltage.”; [0106]: “When calculating the differential signals, the control circuit may differentiate the plurality of first electrocardiographic voltages and the second electrocardiographic voltage in pairs to obtain a plurality of differential signals as the electrocardiograph index signals.”; [0109]-[0111]; Fig. 4).
While Liang’s device teaches a quantization configured to convert the biopotential into digital data to generate biopotential information, Liang’s device does not teach the biopotential amplified by the amplifier before being converted into digital data.
Toth teaches systems and methods for physiological monitoring including ECG ([0003] and [0016]). Systems of Toth includes a microcircuit, which may include a switch bank may be coupled to a processor via a control line, and may be adaptively configured to select individual signals from microelectrodes, electrically tie multiple microelectrode signals together, create a low noise analog interconnection between a microelectrode, a macroelectrode, and one or more inputs to a preamplifier, a second stage amplifier, etc. In aspects, the switch bank and/or preamplifier bank may include one or more conditioning circuits, configured so as to substantially reduce signal content from an extracted signal outside of a target bandwidth, to extract stretch related, movement related, artifacts, to compare a signal against a reference, etc. ([0533] and Fig. 21). Fig. 21 illustrates preamplifier before processing signals via analog to digital converter (ADC).
Therefore, it would have been prima facie obvious to use preamplifier of Toth in the system of Liang in order to reduce signal content from an extracted signal outside of a target bandwidth, to extract stretch related, movement related, artifacts, to compare a signal against a reference.
Regarding claim 13, Liang discloses that each of the plurality of electrode devices ([0054]: “…first electrocardiograph acquisition device (i.e., a master device)…”; [0071]: “…second electrocardiograph acquisition device (i.e., a slave device)…”; Figs. 1 and 2) further includes a communicator ([0085]: “Exemplarily, the wireless transmission circuit 100 of the electrocardiograph acquisition circuit may use technologies such as Bluetooth, Wi-Fi for wireless transmission.”; [0159]: “In this electrocardiograph acquisition system, the wireless transmission mode of the master device and the slave device may use the Bluetooth wireless mesh ad hoc network technology, or Wi-Fi Mesh and other one-to-many low-power data transmission modes.”) configured to transmit a first biopotential information obtained in the electrode device to another one of the plurality of electrode devices and receive a second biopotential information obtained in the other one of the plurality of electrode devices ([0146]: “FIG. 8 is a structural diagram of an electrocardiograph acquisition system according to an embodiment of the present disclosure. With reference to FIG. 8, the electrocardiograph acquisition system includes a master device 31 and a slave device 32. The master device 31 includes the electrocardiograph acquisition circuit as shown in FIG. 1, and the slave device 32 includes the electrocardiograph acquisition circuit as shown in FIG. 2.”; Fig. 8), and
a reference potential generation circuit (differential circuit 132 in Fig. 4, a component of control circuit 103; [0111]: “…a differential circuit 132, configured to obtain a differential signal by differentially amplifying the first electrocardiographic voltage and the second electrocardiographic voltage after digital-to-analog conversion.”) configured to generate a reference potential for the amplifier using the first biopotential information and the second biopotential information (step 403 in Fig. 11; [0104]: “…control circuit 103 is further configured to obtain the electrocardiograph index signal by calculating the differential signal between the second electrocardiographic voltage and the first electrocardiographic voltage when the first acquisition time and the second acquisition time are the same.”; [0111]; [0167]: “In step 403, an electrocardiograph index signal is obtained by processing the first electrocardiographic voltage received by the wireless transmission circuit and the second electrocardiographic voltage acquired by the acquisition circuit based on a first acquisition time of the first electrocardiographic voltage and a second acquisition time of the second electrocardiographic voltage.”).
Regarding claim 14, Liang discloses that the communicator transmits the first biopotential information via light and receives the second biopotential information via light ([0085]: “Exemplarily, the wireless transmission circuit 100 of the electrocardiograph acquisition circuit may use technologies such as Bluetooth, Wi-Fi for wireless transmission.”; [0159]: “In this electrocardiograph acquisition system, the wireless transmission mode of the master device and the slave device may use the Bluetooth wireless mesh ad hoc network technology, or Wi-Fi Mesh and other one-to-many low-power data transmission modes.”).
Regarding claim 16, Liang does not teach that each of the plurality of electrode devices further includes a second electrode for performing human body communication, wherein the communicator transmits the first biopotential information via a human body and receives the second biopotential information via the human body.
However, systems of Toth include a module, where each module may be configured to communicate with one or more patches, additional modules, an analysis device, and/or a host device, etc. Such communication may be performed wirelessly (e.g. acoustically, via infrared, via radio frequency communication, etc.) through the environment surrounding the subject, through the body of the subject (e.g. acoustically, optically, capacitively, resistively, and/or inductively coupled signal transmission, etc.). In aspects, one or more patches may relay a combination of an energy signal (e.g. to determine a physiologic parameter) as well as to communicate an information signal to one or more patches, modules, a host device, etc. ([0298]).
Therefore, it would have been prima facie obvious to use multiple electrode patch configuration of Toth in the system of Liang in order to allow communication of information signals to one or more patches, modules, a host device.
Regarding independent claim 18, Liang discloses an electrode device ([0054]: “…first electrocardiograph acquisition device (i.e., a master device)…”; [0071]: “…second electrocardiograph acquisition device (i.e., a slave device)…”; Figs. 1 and 2) comprising:
an electrode (electrocardiograph electrode 101 in Fig. 1 and electrocardiograph electrode 201 in Fig. 2),
an amplifier configured to amplify a biopotential measured via the electrode ([0114]: Fig. 5 depicts “differential circuit 132 may include two first-stage differential amplifiers A1 and one second-stage differential amplifier A2; [0105]: “Since the directly used electrocardiographic voltage is small, amplification can be achieved by differentiation. Thus, the signal magnitude meets the demands of subsequent signal processing”),
a quantization circuit (analog-to-digital converter 122 in Fig. 3, a component of acquisition circuit 102 in Fig. 1 and 3) configured to convert analog into digital data to generate first biopotential information ([0087]: “The acquisition circuit 102 includes a front-end circuit 121 and an analog-to-digital converter 122. The front-end circuit 121 is configured to convert a current signal detected by the electrocardiograph electrode 101 into an analog voltage signal. The analog-to-digital converter 122 is configured to obtain a digital voltage signal (i.e., the above second electrocardiographic voltage) by periodically sampling the analog voltage signal output by the front-end circuit 121 under the control of the clock signal.”),
a wireless receiver ([0147]: “Since the signal between the electrocardiograph acquisition devices is transmitted wirelessly, there is no need to arrange a connection line on the electrocardiograph acquisition device.”) configured to receive second biopotential information transmitted from another electrode device ([0146]: FIG. 8 is a structural diagram of an electrocardiograph acquisition system according to an embodiment of the present disclosure. With reference to FIG. 8, the electrocardiograph acquisition system includes a master device 31 and a slave device 32. The master device 31 includes the electrocardiograph acquisition circuit as shown in FIG. 1, and the slave device 32 includes the electrocardiograph acquisition circuit as shown in FIG. 2.”), and
an arithmetic circuit (acquisition circuit 102, 201 in Figs. 1-3) configured to generate a biosignal waveform ([0126]: “The control circuit 203 is configured to generate the first electrocardiographic signal based on the first electrocardiographic voltage obtained by the acquisition circuit 201. The first electrocardiographic signal includes the first electrocardiographic voltage and the third acquisition time of the first electrocardiographic voltage.”) using the first biopotential information and the second biopotential information ([0058]: “The control circuit 103 is configured to obtain an electrocardiograph index signal by processing the first electrocardiographic voltage received by the wireless transmission circuit 100 and the second electrocardiographic voltage acquired by the acquisition circuit 102 based on a first acquisition time of the first electrocardiographic voltage and a second acquisition time of the second electrocardiographic voltage.”; [0109]-[0111]; Fig. 4).
While Liang’s device teaches a quantization configured to convert the biopotential into digital data to generate biopotential information, Liang’s device does not teach the biopotential amplified by the amplifier before being converted into digital data.
Toth teaches systems and methods for physiological monitoring including ECG as set forth above.
Therefore, it would have been prima facie obvious to use preamplifier of Toth in the system of Liang in order to reduce signal content from an extracted signal outside of a target bandwidth, to extract stretch related, movement related, artifacts, to compare a signal against a reference.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Liang in view of Moon as applied to claim 13 above, and further in view of Shaya (US 2018/0110475).
Regarding claim 15, Liang in view of Moon discloses the biosignal measurement system with wireless communication means ([0085]: “Exemplarily, the wireless transmission circuit 100 of the electrocardiograph acquisition circuit may use technologies such as Bluetooth, Wi-Fi for wireless transmission.”; [0159]: “In this electrocardiograph acquisition system, the wireless transmission mode of the master device and the slave device may use the Bluetooth wireless mesh ad hoc network technology, or Wi-Fi Mesh and other one-to-many low-power data transmission modes.”).
However, Liang in view of Moon does not teach the communicator transmits the first biopotential information via magnetism and receives the second biopotential information via magnetism.
Shaya teaches emote medical diagnostic and monitoring systems and solutions in which a physician conducts an examination of a remotely located patient, and more specifically, to a system and method for providing a second opinion option and biosensor monitoring ([0002]). The biosensor device includes a sensor for ECG (Abstract). Shaya further teaches wireless communication using near field communication (NFC), which is a short-range wireless connectivity standard (Ecma-340, ISO/IEC 18092) that uses magnetic field induction to enable communication between devices when they are touched together, or brought within a few centimeters of each other in zone 1424 ([0191]). The standard specifies a way for the devices to establish a peer-to-peer (P2P) network to exchange data ([0191]). After the P2P network has been configured, another wireless communication technology, such as Bluetooth, cellular, or Wi-Fi Connectivity, can be used for longer range communication or for transferring larger amounts of data ([0191]).
Therefore, it would have been prima facie obvious to include NFC and Bluetooth, cellular, or Wi-Fi wireless communication device as taught by Shaya in the system of Liang in view of Moon in order to allow both short-range wireless connectivity and longer range communication for transferring larger amounts of data.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Takahashi et al. (US 2014/0142447).
Moon et al. (US 2011/0066051) teaches a body-worn monitor featuring a processing system that receives a digital data stream from an ECG system (Abstract). A cable houses the ECG system at one terminal end, and plugs into the processing system, which is worn on the patient's wrist like a conventional wristwatch (Abstract). The ECG system features: i) a connecting portion connected to multiple electrodes worn by the patient; ii) a differential amplifier that receives electrical signals from each electrode and process them to generate an analog ECG waveform; iii) an analog-to-digital converter that converts the analog ECG waveform into a digital ECG waveform; and iv) a transceiver that transmits a digital data stream representing the digital ECG waveform (or information calculated from the waveform) through the cable and to the processing system. Different ECG systems, typically featuring three, five, or twelve electrodes, can be interchanged with one another (Abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY G SCHLUETER whose telephone number is (703)756-4601. The examiner can normally be reached M-F 9:00am-5:30pm EST.
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, Unsu Jung can be reached at (571) 272-8506. 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.
/M.G.S./Examiner, Art Unit 3796
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights