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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 18681487, filed on 02/05/2024.
Claim Objections
Claim 15 objected to because of the following informalities: claim 15 recites “analysed” which should be corrected to “analyzed”. Appropriate correction is required.
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 (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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4, 7-10, and 16-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yun-Hsuan Chen ET AL: "Soft, Comfortable Polymer Dry Electrodes for High Quality ECG and EEG Recording", Sensors, vol. 14, no. 12, 10 December 2014 (2014-12-10), pages 23758-23780, XP055498820, DOI: 10.3390/s141223758.
Regarding claim 1, Chen et. al teaches an electrode testing device, for testing electrodes ([Pg 23759; Para 3] In this paper, the electrodes used for the ECG/EEG measurements are subject of investigation. An important criterion for suitable electrodes is low impedance to limit the noise generated during signal recording, jeopardizing the accuracy of the obtained biopotential signals), comprising: at least one electrode mounting holder ([Pg 23767; Para 1] The assembled polymer dry electrodes were mounted on the subject’s scalp by using elastic bands as shown in Figure 5a), for holding an electrode to be tested (Fig 5); at least one user mount for holding a limb or digit of a user ([Pg 23767; Para 1] The assembled polymer dry electrodes were mounted on the subject’s scalp by using elastic bands as shown in Figure 5a. The length of each elastic band is adjustable, in order to realize a suitable fit for most common adult head sizes); wherein the user mount is configured to enable the electrode to be in contact with the skin of the user ([Pg 23768; Para 3] During the impedance evaluation and ECG/EEG measurements, the dry electrodes contacted the skin for at least half an hour); and an electrical signal acquisition module ([Pg 23771; Para 2] The filtered ECG signals acquired by conductive polymer dry electrodes and by conventional wet electrodes are shown in Figure 9a), wherein the electrical signal acquisition module acquires biometric electrical signals from the user through the contact of the electrode with the skin of the user ([Pg 23768; Para 3] During the impedance evaluation and ECG/EEG measurements, the dry electrodes contacted the skin for at least half an hour, corresponding to short-term use of the electrodes).
Regarding claim 2, Chen et. al teaches an electrode testing device of claim 1, wherein the at least one user mount comprises guides to hold of the limb or digit of the user ([Pg 23771; Para 2] The pins of electrode bend to support the force from headset, elastic bands or other mounting devices) ([Pg 23774; Para 4] The pressure on the skin was at least sufficient for good electrode-skin contact, but often also higher, e.g. related to the size of the head and the elastic band for EEG monitoring).
Regarding claim 4, Chen et. al teaches the electrode testing device of claim1, wherein the at least one electrode is a dry material ([Pg 23767; Para 1] The assembled polymer dry electrodes were mounted on the subject’s scalp by using elastic bands as shown in Figure 5a).
Regarding claim 7, Chen et. al teaches the electrode testing device of claim 1, wherein the at least one electrode mounting holder comprises: a plurality of electrode material sample holders; and an electrode material mounting slot, wherein an electrode material sample holder of the plurality of electrode material sample holders is housed within the electrode material mounting slot ([Pg 23761; Para 2] Cylindrical shaped electrodes with 13 mm diameter and 5 mm height were also fabricated for each material mixture, in order to test their mechanical properties and other material characterization tests, these electrodes are further called “bulk electrodes”) ([Pg 23762; Para 3] the cylindrical shaped bulk electrodes (Figure 1b) with various carbon contents in the polymer are used to study the material conductivity. Two Au-coated plates were used to contact the top and bottom surface of each sample. A clamp was used to stabilize the bulk sample in between the two metal plates).
Regarding claim 8, Chen et. al teaches the electrode testing device of claim 7, wherein the plurality of electrode material sample holders comprise a plurality of material contact areas ([Pg 23761; Para 2] Cylindrical shaped electrodes with 13 mm diameter and 5 mm height were also fabricated for each material mixture, in order to test their mechanical properties and other material characterization tests, these electrodes are further called “bulk electrodes”) ([Pg 23762; Para 3] the cylindrical shaped bulk electrodes (Figure 1b) with various carbon contents in the polymer are used to study the material conductivity. Two Au-coated plates were used to contact the top and bottom surface of each sample. A clamp was used to stabilize the bulk sample in between the two metal plates).
Regarding claim 9, Chen et. al teaches the electrode testing device of clam 1, wherein one of the at least one user mounts is replaced with a strap-type electrode suitable for strapping to a user's body ([Pg 23771; Para 2] The pins of electrode bend to support the force from headset, elastic bands or other mounting devices) ([Pg 23768; Para 4] The second long term experiment was performed on the same subject but using an electrode with pins of 5 mm length for 60 h. An elastic bandage is used to fix the electrode on the upper arm, as a replacement for the sticker used during the first long term experiment).
Regarding claim 10, Chen et. al teaches the electrode testing device of claim 1, wherein the variable tension pins are configured to provide matching incremental tension values on at least one user mount ([Pg 23774; Para 4] Two electrode designs with pins of 2 mm and 5 mm length (see Figures 13a and 14a) were selected. These electrodes were placed on the skin with sufficient pressure to ensure low contact impedance, and the skin was evaluated after 30 min and 1 h of electrode contact. No pain nor discomfort was reported, and only a shallow impression on the skin was seen (see Figures 13c,d and 14c,d)).
Regarding claim 16, Chen et. al teaches an electrode testing method of an electrode testing device ([Pg 23759; Para 3] In this paper, the electrodes used for the ECG/EEG measurements are subject of investigation. An important criterion for suitable electrodes is low impedance to limit the noise generated during signal recording, jeopardizing the accuracy of the obtained biopotential signals), comprising: installing one or more electrodes into at least one electrode mounting holder ([Pg 23767; Para 1] The assembled polymer dry electrodes were mounted on the subject’s scalp by using elastic bands as shown in Figure 5a); placing a limb or digit of a user into at least one user mount ([Pg 23767; Para 1] The assembled polymer dry electrodes were mounted on the subject’s scalp by using elastic bands as shown in Figure 5a. The length of each elastic band is adjustable, in order to realize a suitable fit for most common adult head sizes), wherein the at least one user mount is configured to enable the electrode to be in contact with the skin of the user ([Pg 23768; Para 3] During the impedance evaluation and ECG/EEG measurements, the dry electrodes contacted the skin for at least half an hour); and, acquiring, from an electrical signal acquisition module, a biometric electrical signal from the user ([Pg 23768; Para 3] During the impedance evaluation and ECG/EEG measurements, the dry electrodes contacted the skin for at least half an hour, corresponding to short-term use of the electrodes).
Regarding claim 17, Chen et. al teaches the electrode testing method of claim 16, wherein the biometric electrical signal is an electrocardiograph (ECG) signal ([Pg 23768; Para 3] During the impedance evaluation and ECG/EEG measurements, the dry electrodes contacted the skin for at least half an hour, corresponding to short-term use of the electrodes).
Regarding claim 18, Chen et. al teaches the electrode testing method of claim 16, further comprising acquiring offset potential data of each electrode interface ([Pg 23766; Para 1] Such a so-called “active electrode setup” helps reduce the interference from the environment, such as 50 Hz noise and signal disturbance caused by cable movement. Amplification of the active circuit can be considered to achieve higher signal to noise ratio (SNR), but in this paper, an active circuit without amplification (acting as a unity gain buffer amplifier) was used for the EEG recordings) ([Pg 23768; Para 2] the signal to noise ratio of the “eyes-closed signals” was calculated by the ratio of power spectrum density of alpha waves signal to that of the signal in 2–30 Hz, as described in [36]).
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.
Claim(s) 3, 5, 6, 11-15, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yun-Hsuan Chen ET AL: "Soft, Comfortable Polymer Dry Electrodes for High Quality ECG and EEG Recording", Sensors, vol. 14, no. 12, 10 December 2014 (2014-12-10), pages 23758-23780, XP055498820, DOI: 10.3390/s141223758 in view of Thng (WO 2016053731 A1).
Regarding claim 3, Chen et. al teaches electrode testing device of claim 1, wherein the at least one user mount comprises variable tension pins ([Pg 23771; Para 2] The pins of electrode bend to support the force from headset, elastic bands or other mounting devices) ([Pg 23768; Para 4] The second long term experiment was performed on the same subject but using an electrode with pins of 5 mm length for 60 h. An elastic bandage is used to fix the electrode on the upper arm, as a replacement for the sticker used during the first long term experiment). Chen fails to fully teach wherein the at least one user mount comprises variable tension pins.
However, Thng teaches wherein the at least one user mount comprises variable tension pins ([0024] the mounting locations could locations on an elastic waist band of an undergarment. The mounts could be in the form of clips, adhesive strips, pins, flexible hooks, or any other means for removably mounting elements of such a device on or within the garment). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Chen to include wherein the at least one user mount comprises variable tension pins. Doing so allows for a more secure fit of the electrode and improved recordings.
Regarding claim 5, Chen et. al teaches the electrode testing device of claim 1, but fails to teach wherein the electrode mounting holders are detachable from the electrode testing device. However, Thng teaches wherein the electrode mounting holders are detachable from the electrode testing device ([0024] The housing may include a mount for removably mounting the housing to the garment at a first mounting location, and the remote electrode may include a mount for removably mounting the remote electrode to the garment at a second mounting location. The mounting locations on the garment could be locations at which the garment presses the reference and remote electrodes against the skin of the wearer (i.e., locations at which the garment exerts significant normal forces into the skin of the wearer)) ([0077] The device 400b includes a first mount (in the form of a pin 415b and clasp 417b) configured to pin (i.e., to removably mount) the housing 430b to a first mounting location (e.g., a band, a strap, a hem, an edge) of the garment 403b. The device 400b also includes a second mount (in the form of a pin 425b and clasp 427b) configured to pin (i.e., to removably mount) the remote electrode 420b to a second mounting location of the garment 403b). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Chen to include wherein the electrode mounting holders are detachable from the electrode testing device. Doing so allows the device to be moved in a location that may be better suited for detecting signals.
Regarding claim 6, Chen et. al teaches the electrode testing device of claim 1, but fails to teach wherein the at least one user mount is detachable from the electrode testing device. However, Thng teaches wherein the at least one user mount is detachable from the electrode testing device ([0024] The housing may include a mount for removably mounting the housing to the garment at a first mounting location, and the remote electrode may include a mount for removably mounting the remote electrode to the garment at a second mounting location. The mounting locations on the garment could be locations at which the garment presses the reference and remote electrodes against the skin of the wearer (i.e., locations at which the garment exerts significant normal forces into the skin of the wearer)) ([0077] The device 400b includes a first mount (in the form of a pin 415b and clasp 417b) configured to pin (i.e., to removably mount) the housing 430b to a first mounting location (e.g., a band, a strap, a hem, an edge) of the garment 403b. The device 400b also includes a second mount (in the form of a pin 425b and clasp 427b) configured to pin (i.e., to removably mount) the remote electrode 420b to a second mounting location of the garment 403b). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Chen to include wherein the at least one user mount is detachable from the electrode testing device. Doing so allows the device to be moved in a location that may be better suited for detecting signals.
Regarding claim 11, Chen et. al teaches the electrode testing device of claim 1, but fails to teach further comprising a power source, wherein the power source is a battery. However, Thng teaches further comprising a power source, wherein the power source is a battery (Fig 6; rechargeable battery 635). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Chen to include further comprising a power source, wherein the power source is a battery. Doing so allows power to be supplied by a battery for detachment from the main device.
Regarding claim 12, Chen et. al teaches the electrode testing device of claim 1, but fails to teach further comprising a display screen, wherein the display screen is an LCD screen. However, Thng teaches further comprising a display screen, wherein the display screen is an LCD screen ([00120] the method 700 could include indicating the extracted ECG signal and/or information related to the ECG signal using a display disposed in the device) ([00113] The alert may include a visual component, such as a flashing light or other operation of an LED or other visual indicator (e.g., a display)). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Chen to include further comprising a display screen, wherein the display screen is an LCD screen. Doing so allows the user to be informed on a screen of the status of the device to ensure accurate collection of data.
Regarding claim 13, Chen et. al teaches the electrode testing device of claim 12, but fails to teach wherein the display screen displays information related to detection status, connection status, signal quality, biometric electrical signal values, electrode temperature, and/or battery life. However, Thng teaches wherein the display screen displays information related to detection status, connection status, signal quality, biometric electrical signal values, electrode temperature, and/or battery life ([00108] The program instructions 672 can include instructions for operating the user interface(s) 680. For example, the program instructions 672 could include instructions for displaying data about the device 600 (e.g., by operating one or more indicator LEDs of the device, by operating a vibrator or other tactile stimulator of the device), or for indicating one or more alerts generated by the device 600 and/or received from an external system) ([00101] The program instructions 672 could include instructions to operate based on parameter and user data 674 stored in the computer readable medium 660 and/or modify the parameters and user data 674. For example, the parameters and user data 674 could include calibration data for the device 600 and/or stored ECG signals (and/or features thereof, e.g., Q-T intervals, QRS complex parameters) extracted using the device 600) ([0048] Such an indication could be related to a property of the voltage fluctuations between two or more electrodes of the device, e.g., the device could provide an indication of the strength (or some other metric of signal quality) of ECG signals extracted by the device such that a wearer (or other user) could mount the two or more electrodes at mounting locations that provide ECG signal(s) of sufficient quality for an application). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Chen to include wherein the display screen displays information related to detection status, connection status, signal quality, biometric electrical signal values, electrode temperature, and/or battery life. Doing so allows the user to be informed on the status of the device to ensure accurate detection and collection of data.
Regarding claim 14, Chen et. al teaches the electrode testing device of claim 1, but fails to teach further comprising a wireless network communication module. However, Thng teaches further comprising a wireless network communication module ([0080] the communication interface 515 includes a wireless transceiver for sending and receiving communications (e.g., indications of a measured skin resistance and/or capacitance) to and from the server 530. In further embodiments, the communication interface 515 may include any means for the transfer of data, including both wired and wireless communications). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Chen to include further comprising a wireless network communication module. Doing so allows the data collected to be analyzed remotely for accurate interpretation and saved for future reference
Regarding claim 15, Chen et. al teaches the electrode testing device of claim 1, but fails to teach wherein the biometric electrical signals are configured to enable uploading to a cloud and analyzed remotely using biometric analysis software. However, Thng teaches wherein the biometric electrical signals are configured to enable uploading to a cloud ([0080] Communication networks 520 may include any of: a plain old telephone service (POTS) network, a cellular network, a fiber network and a data network. The server 530 may include any type of remote computing device or remote cloud computing network) and analyzed remotely using biometric analysis software ([0083] where a wearer's collected data are uploaded to a cloud computing network for analysis by a clinician, the data may be treated in one or more ways before it is stored or used, so that personally identifiable information is removed). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Chen to include wherein the biometric electrical signals are configured to enable uploading to a cloud and analyzed remotely using biometric analysis software. Doing so allows the data collected to be analyzed remotely for accurate interpretation and saved for future reference.
Regarding claim 19, Chen et. al teaches a system for testing electrodes ([Pg 23759; Para 3] In this paper, the electrodes used for the ECG/EEG measurements are subject of investigation. An important criterion for suitable electrodes is low impedance to limit the noise generated during signal recording, jeopardizing the accuracy of the obtained biopotential signals), comprising: an electrode testing device comprising: at least one electrode mounting holder ([Pg 23767; Para 1] The assembled polymer dry electrodes were mounted on the subject’s scalp by using elastic bands as shown in Figure 5a), configured for holding an electrode to be tested ([Pg 23767; Para 1] The assembled polymer dry electrodes were mounted on the subject’s scalp by using elastic bands as shown in Figure 5a); at least one user mount configured for holding a limb or digit of a user ([Pg 23767; Para 1] The assembled polymer dry electrodes were mounted on the subject’s scalp by using elastic bands as shown in Figure 5a. The length of each elastic band is adjustable, in order to realize a suitable fit for most common adult head sizes), wherein the user mount is configured to enable the electrode to be in contact with the skin of the user ([Pg 23768; Para 3] During the impedance evaluation and ECG/EEG measurements, the dry electrodes contacted the skin for at least half an hour); and an electrical signal acquisition module, wherein the electrical signal acquisition module is configured to acquire biometric electrical signals from the user through the contact of the electrode with the skin of the user ([Pg 23768; Para 3] During the impedance evaluation and ECG/EEG measurements, the dry electrodes contacted the skin for at least half an hour, corresponding to short-term use of the electrodes).
Chen fails to teach an electronic computing device comprising biometric analysis software; a wireless communication system operable to effect communication of data between the electrode testing device and the electronic computing device; and a cloud server.
However, Thng teaches an electronic computing device comprising biometric analysis software ([0083] where a wearer's collected data are uploaded to a cloud computing network for analysis by a clinician, the data may be treated in one or more ways before it is stored or used, so that personally identifiable information is removed); a wireless communication system operable to effect communication of data between the electrode testing device and the electronic computing device ([0080] the communication interface 515 includes a wireless transceiver for sending and receiving communications (e.g., indications of a measured skin resistance and/or capacitance) to and from the server 530. In further embodiments, the communication interface 515 may include any means for the transfer of data, including both wired and wireless communications); and a cloud server ([0080] Communication networks 520 may include any of: a plain old telephone service (POTS) network, a cellular network, a fiber network and a data network. The server 530 may include any type of remote computing device or remote cloud computing network). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Chen to include an electronic computing device comprising biometric analysis software; a wireless communication system operable to effect communication of data between the electrode testing device and the electronic computing device; and a cloud server. Doing so allows the data collected to be analyzed remotely for accurate interpretation and saved for future reference.
Regarding claim 20, Chen et. al teaches the system of claim 19, further comprising a digital temperature meter. However, Thng teaches further comprising a digital temperature meter ([00100] The signal conditioner 630 could include components to operate some other sensors (e.g., accelerometers, optical pulse sensors, photoplethysmographic sensors, pulse oximeters, temperature sensors) configured to detect one or more properties of a wearer of the device 600 and/or of the environment of the device 600). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the invention of Chen to include further comprising a digital temperature meter. Doing so allows the user to monitor the temperature of the electrode so that the subject is not injured by overheating.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794