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 .
Status of Claims
Claims 1-17 are rejected.
Response to Arguments
Claim Rejections - 35 USC § 101
The previous 101 human organism rejection has been withdrawn in view of the amendment.
Applicant's arguments filed 1/28/26 have been fully considered but they are not persuasive.
Applicant argues that the claims provide improved performance of the wearable electronic device by improving the signal quality and the accuracy of the device. However, the Examiner disagrees. MPEP 2106.05(a) states:
It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.
The alleged improvement is directed to the abstract idea. Based on the above section from MPEP 2106.05(a), the abstract idea alone cannot provide the improvement but can be provided by the abstract idea in combination with the additional elements.
Applicant asserts that with reference to the prior art rejections, the prior art does not provide to a user such a wearing state indicating a degree of contact between a wearable device and skin of the user. Applicant additionally states that these claims are not reasonably interpreted as well understood, routine, or conventional activity. However, the Examiner disagrees. MPEP 2106.05 states:
As made clear by the courts, the "‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter." Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9). See also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) ("a claim for a new abstract idea is still an abstract idea. The search for a § 101 inventive concept is thus distinct from demonstrating § 102 novelty."). In addition, the search for an inventive concept is different from an obviousness analysis under 35 U.S.C. 103. See, e.g., BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016) ("The inventive concept inquiry requires more than recognizing that each claim element, by itself, was known in the art. . . . [A]n inventive concept can be found in the non-conventional and non-generic arrangement of known, conventional pieces.").
Additionally, that limitation of providing to a user a wearing state indicating a degree of contact between a wearable device and skin of the user is directed to the abstract idea and is not an additional element.
Applicant asserts that these claims are directed towards fixing a problem in a device and are not reasonable interpreted as a method of organizing human behavior. However, the Examiner disagrees. The steps as claims towards fixing a problem in the device are directed to the abstract idea as shown in the rejection below.
Applicant states that this application is similar to the example in MPEP 2106.04(a)(1)(iii), which is an earring comprising a sensor for taking periodic blood glucose measurements and a memory for storing measurement data from the sensor. However, this does not recite an abstract idea, while the instant application does recite an abstract idea.
Claim Rejections - 35 USC § 112
The previous 112(b) rejection of claim 3 has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 103
Applicant’s arguments with respect to claims 1-3, 8, and 10-12 have been considered but are moot. Applicant asserts that the cited references do not disclose or suggest “determine a wearing state of the wearable device based on an intensity of the EMG signal and a quality of the second ECG signal,” and “output, to the user, a guide on the wearing state based on a result of the determination,” “wherein the wearing state indicates a degree of contact between the wearable device and skin of the user.”
However, Zhao teaches to determine a wearing state of the wearable device based on an intensity of the EMG signal and a quality of the second ECG signal (page 13, ¶1-the ECG/EMG signals obtained from the electrodes were filtered, amplified, digitized, and then transmitted to a remote receiver (i.e., smart phone or laptop) via the BLE module for further analysis; page 10, ¶1-upper limb muscle activity intensity could be detected and used for EMG monitoring in rehabilitation training; page 7, ¶1-the obtained data nearly approached the actual ECG signal and reliably), and output, to the user, a guide on the wearing state based on a result of the determination (page 11, ¶1-a two-graph panel was designed to display the real-time graphical illustrations of the EMG and the ECG data; page 6, ¶1-the upper limb muscles (FCR and ECRL) are monitored by the EMG sensors, and the heart health status are monitored by the ECG sensor, which could real time adjust and give scientific guidance on control strategy for hand rehabilitation training).
While the combination of Derkx and Zhao teaches that the ECG/EMG signals obtained from the electrodes were filtered, amplified, digitized, and then transmitted (Zhao, page 13, ¶1), the combination fails to teach wherein the wearing state indicates a degree of contact between the wearable device and skin of the user.
Newly applied reference Gunasekar (US 20180317848) teaches wherein the wearing state indicates a degree of contact between the wearable device and skin of the user (¶13-generating an electrode adjustment prompt; ¶15-systematically characterize the quality of contact between electrodes—in the electrical biosignal acquisition system 100—and a user's skin and to automatically provide guidance for improving such contact quality).
The rejection of claims 4 and 14 as well as the dependency from claims 5-7, 9, and 17 has been withdrawn as intervening reference He is no longer acceptable prior art for priority based on Applicant filing a certified English Translation of the foreign priority document for the instant application. The rejection of claim 15 has similarly been withdrawn.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-11 and 13-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea without significantly more.
Step 1
The claimed invention in claims 1-11 and 13-17 are directed to statutory subject matter as the claims recite a device and method for determining a wearing state.
Step 2A, Prong One
Regarding claims 1 and 10, the recited steps are directed to a mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsection (III)).
Regarding claims 1 and 10, the limitations of “obtain a second ECG signal by filtering the EMG signal from the first ECG signal, determine a wearing state of the wearable device based on an intensity of the EMG signal and a quality of the second ECG signal, and output, to the user, a guide on the wearing state based on a result of the determination, wherein the wearing state indicates a degree of contact between the wearable device and skin of the user” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional removing outliers from an ECG signal using pen and paper, analyzing the EMG signal intensity and quality of the second ECG signal to determine a wearing state of the wearable device and skin of the user, and writing down a guide based on the result of the determination.
Step 2A, Prong Two
For claims 1 and 10, the judicial exception is not integrated into a practical application. In particular, claims 1 and 10 recite “a first biometric sensor having a plurality of electrodes and at least one processor.” The first biometric sensor having a plurality of electrodes amount to nothing more than pre-solution activity of data gathering. The at least one processor is recited at a high-level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into
a practical application, the additional element of a first biometric sensor having a plurality of electrodes amounts to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, the first sensor having a plurality of electrodes is well-understood, routine, and conventional activity as evidenced by US 20140257049 (¶16-the generation of an ECG signal based on contact with two electrodes engaged by different parts of a person's body is known in the art, such is shown for example by U.S. Pat. No. 5,316,008 incorporated by reference above, and is thus not further described herein; ¶10), (¶18-in the conventional ECG measurements, 4 electrodes are attached to the patient's limbs, typically on the wrists and ankles), and US 20160270738 (¶84-the plurality of ECG sensing electrodes 120 may incorporate any electrode system, including conventional stick-on adhesive electrodes, dry-sensing capacitive ECG electrodes, radio transparent electrodes, segmented electrodes, or one or more long term wear electrodes that are configured to be continuously worn by a subject for extended periods (e.g., 3 or more days). Further, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)). In this case, elements of general computer are being used to implement the abstract idea.
Regarding dependent claims 2-9, 11, and 13-17, the limitations of claims 1 and 10 further define the limitations already indicated as being directed to the abstract idea.
Regarding claim 2, the judicial exception is not integrated into a practical application. In particular, claim 2 recites “a display; and a housing configured to surround the display, wherein a first electrode among the plurality of electrodes is arranged on a bottom surface of the housing, and wherein a second electrode is arranged on a side surface or top surface of the housing.” The display and housing amount to parts of a generic computer. The first electrode and the second electrode amount to pre-solution activity of data gathering. “Wherein a first electrode among the plurality of electrodes is arranged on a bottom surface of the housing, and wherein a second electrode is arranged on a side surface or top surface of the housing” is well-understood, routine, and conventional under Step 2B as evidenced by US 20160192856 (Abstract-a housing including first and second electrodes on a bottom surface thereof, and a third electrode on a top surface thereof), US 20170296088 (Abstract-a housing having a top surface and a bottom surface, a first electrode disposed on the top surface of the housing, the first electrode electrically isolated from rest of the top surface, a second electrode disposed on the bottom surface of the housing), and US 20150313484 (claim 1-an electrocardiogram (ECG) sensor having a first electrode located at a front side of the housing and a second electrode located at a bottom side of the housing).
Regarding claim 3, the limitations of “filter the EMG signal from the first ECG signal, and remove noise in addition to the EMG signal from the signal obtained by filtering the EMG signal, so as to obtain the second ECG signal” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional receiving a print out of EMG and a first ECG signal, filtering values of the EMG signal on paper to remove noise and obtain the second ECG signal. The at least one processor is recited at a high-level of generality and amount to nothing more than parts of a generic computer.
Regarding claim 4, the limitation of “in case that the intensity of the EMG signal is greater than or equal to a first reference value and the quality of the second ECG signal is less than or equal to a second reference value” is a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional comparing print outs of the EMG and ECG signal to reference values. The limitation of “output a message indicating that the wearing state is an overly close contact state” amounts to certain methods of organizing human activity. For example, a medical professional verbally communicates to the patient that the wearing state is an overly close contact state.
Regarding claim 5, the limitations of “output a message indicating that the wearing state is the overly close contact state and a re-measurement request message and output a guide on the re-wearing state based on the determination result” amount to certain methods of organizing human activity. For example, a medical professional verbally communicates to the patient a message about the wearing state and a guide on the re-wearing state. The judicial exception is not integrated into a practical application. In particular, claim 5 recites “obtain a third ECG signal using the first biometric sensor in response to the wearable device being worn on the user’s body based on a response to the re-measurement request message.” The first sensor amounts to pre-solution activity of data gathering. The first sensor has been shown to be well-understood, routine, and conventional as evidenced for claim 1. The limitations of “obtain a second EMG signal from the third ECG signal, obtain a fourth ECG signal by filtering the second EMG signal from the third ECG signal, determine a re-wearing state of the wearable device based on an intensity of the second EMG signal and a quality of the fourth ECG signal” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional making determinations about further ECG signals based on print outs and filtering on paper, and using these determinations to determine a re-wearing state.
Regarding claim 6, the at least one processor is recited at a high-level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea of storing information on a computer does not integrate a judicial exception into practical application. The limitation of “output the guide on the wearing state, among the plurality of wearing states, corresponding to a range of the intensity of the ECG signal and a range of the quality of the second ECG signal” amounts to certain methods of organizing human activity. For example, a medical professional verbally communicates to the patient one of the guides on the plurality of wearing states corresponding to the range of the intensity of different ECG signals and the range of the quality of the second ECG signal.
Regarding claim 7, the judicial exception is not integrated into a practical application. In particular, claim 7 recites “a memory.” The memory is recited at a high-level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Regarding claim 8, the judicial exception is not integrated into a practical application. In particular, claim 8 recites “a second biometric sensor having a light emitting module and a light receiving module; and obtain a photoplethysmography (PPG) signal using the second biometric sensor while the wearable device is worn on the user’s body.” The second biometric sensor having a light emitting module and a light receiving module amounts to pre-solution activity of data gathering. “A second biometric sensor having a light emitting module and a light receiving module; and obtain a photoplethysmography (PPG) signal using the second biometric sensor while the wearable device is worn on the user’s body” is well-understood, routine, and conventional under Step 2B as evidenced by US 20140257049 (¶13-the photo diode 40 and LED 44 are constructed and arranged such that the photo diode 40 only receives reflected light of the LED 44. The photo diode 40 generates a signal indicative of the reflected light from the person's skin that it receives. The photo diode 40 and LED 44 are part of a PPG circuit), US 20180035943 (¶61-the PPG's emitters and photodiodes and the ECG's electrodes, come in contact with the skin of the user), and US 20190125187 (¶19-the optical sensor 126 may comprise at least one light emitter and a photodiode, the light emitter generates light (e.g. visible or infrared light) to the left index finger of the user).
Regarding claim 9, the judicial exception is not integrated into a practical application. In particular, claim 9 recites “a display.” The display is recited at a high-level of generality and amounts to nothing more than parts of a generic computer. Regarding the limitation “a display, wherein the at least one processor is further configured to provide a notification of the wearing state through the display,” merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Regarding claim 11, the judicial exception is not integrated into a practical application. In particular, claim 11 recites “wherein the wearable device comprises a display and a housing surrounding the display, wherein the first biometric sensor comprises a plurality of electrodes, wherein a first electrode among the plurality of electrodes is arranged on a bottom surface of the housing, and wherein a second electrode is arranged on a side surface or top surface of the housing.” The first biometric sensor comprising a plurality of electrodes and a second electrode amount to nothing more than pre-solution activity of data gathering. The housing and display are recited at a high-level of generality and amounts to nothing more than parts of a generic computer. “Wherein the wearable device comprises a display and a housing surrounding the display, wherein the first biometric sensor comprises a plurality of electrodes, wherein a first electrode among the plurality of electrodes is arranged on a bottom surface of the housing, and wherein a second electrode is arranged on a side surface or top surface of the housing” is well-understood, routine, and conventional under Step 2B as evidenced by US 20160192856 (Abstract-a housing including first and second electrodes on a bottom surface thereof, and a third electrode on a top surface thereof; ¶23-the housing 102 of the sensor pod 100 can optionally include a digital display), US 20170296088 (Abstract-a housing having a top surface and a bottom surface, a first electrode disposed on the top surface of the housing, the first electrode electrically isolated from rest of the top surface, a second electrode disposed on the bottom surface of the housing; ¶36-the electronic device 100 may include a display module 110), and US 20200229761 (¶5-a touch-sensitive display at least partially within the housing; ¶67-the rear-facing electrode 216 may be formed (e.g., printed, plated, or otherwise deposited) on the back side housing member 206b; ¶68-the electrode(s) on the crown 210 or button 212 may be conductive surfaces of the crown 210).
Regarding claim 12, the limitation of “wherein the first electrode is arranged on the display, and the second electrode is arranged on a portion of the housing” was not found to be well-understood, routine, or conventional activity. Therefore, the claims 1 and 10 would be found eligible if this specific configured was recited in the independent claims.
Regarding claim 13, the limitations of “wherein obtaining the second ECG signal comprises: passing the first ECG signal through a first filter; and passing the signal having passed through the first filter, through a second filter, and wherein the first filter and the second filter have different frequency bands” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional receiving a print out of the first ECG signal, filtering values from it, and filtering it a second time based on a different frequency band.
Regarding claim 14, the limitation of “wherein outputting the guide on the wearing state comprises: outputting a message on the degree of contact between the wearable device and skin of the user using at least one of sound, vibration, or screen” amounts to certain methods of organizing human activity. For example, a medical professional verbally communicates to the patient a guide on the wearing state.
Regarding claim 15, the limitations of “in case that the intensity of the EMG signal is greater than or equal to a first reference value and the quality of the second ECG signal is less than or equal to a second reference value, outputting a message indicating that the wearing state is an overly close contact state” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional receiving print outs of an EMG signal and an ECG signal and comparing them to reference values.
Regarding claim 16, a bioelectrical impedance analysis (BIA) sensor amounts to pre-solution activity of data gathering and is well-understood, routine, and conventional activity as evidenced by: US 11701023 (col. 5 and lines 6-7-conventional bioimpedance sensors), US 20150157219 (¶47-conventional bioimpedance sensors), and US 20060200033 (¶129-conventional spot electrodes, which are used, e.g., in bioimpedance systems).
Regarding claim 17, the limitation “wherein the notification includes an animation including one of a traffic light or a gauge” merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Claim Rejections - 35 USC § 103
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 1, 3, 10, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Derkx (EP 3381354 filed on 3/31/17) in view of Zhao (NPL “Wearable Physiological Monitoring System Based on Electrocardiography and Electromyography for Upper Limb Rehabilitation Training” published in August 2020) and Gunasekar (US 20180317848 filed on 10/31/17).
Regarding claim 1, Derkx teaches a wearable device comprising: a first biometric sensor having a plurality of electrodes (¶63-two EMG electrodes 210 are provided at the second intercostal space of a user 220, with one electrode located at either side of the sternum); memory, comprising one or more storage media (¶91-one or more storage media such as volatile and non-volatile computer memory such as RAM, PROM, EPROM, and EEPROM), storing instructions (¶91-when executed on one or more processors and/or controllers, perform the required functions); and at least one processor configured to be electrically connected to the first biometric sensor and the memory (¶89-a processor is one example of a controller which employs one or more microprocessors that maybe programmed using software (e.g., microcode) to perform the required functions; ¶64-the EMG electrodes detect a combined signal, containing EMG and ECG signals of the user, which may then be provided to a signal processing unit 230; ¶91), wherein the instructions, when executed by the at least one processor, are configured to: obtain a first electrocardiogram (ECG) signal (¶6-obtaining a combined signal, wherein the combined signal comprises an ECG signal and an EMG signal; applying a first high pass filter to the combined signal; generating an ECG model signal based on the high pass filtered combined signal) using the first biometric sensor while the wearable device is worn on a user's body (¶63-two EMG electrodes 210 are provided at the second intercostal space of a user 220, with one electrode located at either side of the sternum; ¶64-the EMG electrodes detect a combined signal, containing EMG and ECG signals of the user), obtain an electromyograph (EMG) signal from the first ECG signal (¶6-obtaining a combined signal, wherein the combined signal comprises an ECG signal and an EMG signal; applying a first high pass filter to the combined signal; generating an ECG model signal based on the high pass filtered combined signal; generating a first EMG signal based on at least one of the ECG model signal), and obtain a second ECG signal by filtering the EMG signal from the first ECG signal (¶6-applying a second high pass filter to the first EMG signal to generate a second EMG signal and to the ECG model signal to generate a second ECG model signal). However, Derkx does not teach determine a wearing state of the wearable device based on an intensity of the EMG signal and a quality of the second ECG signal, and output, to the user, a guide on the wearing state based on a result of the determination, wherein the wearing state indicates a degree of contact between the wearable device and skin of the user.
Zhao relates generally to a wearable monitoring device for upper limb rehabilitation by integrating electrocardiogram and electromyogram (ECG/EMG) sensors and using data acquisition boards to obtain accurate signals during robotic glove assisting training (Abstract). Zhao further teaches the invention using the following steps:
determine a wearing state of the wearable device based on an intensity of the EMG signal and a quality of the second ECG signal (page 13, ¶1-the ECG/EMG signals obtained from the electrodes were filtered, amplified, digitized, and then transmitted to a remote receiver (i.e., smart phone or laptop) via the BLE module for further analysis; page 10, ¶1-upper limb muscle activity intensity could be detected and used for EMG monitoring in rehabilitation training; page 7, ¶1-the obtained data nearly approached the actual ECG signal and reliably), and output, to the user, a guide on the wearing state based on a result of the determination (page 11, ¶1-a two-graph panel was designed to display the real-time graphical illustrations of the EMG and the ECG data; page 6, ¶1-the upper limb muscles (FCR and ECRL) are monitored by the EMG sensors, and the heart health status are monitored by the ECG sensor, which could real time adjust and give scientific guidance on control strategy for hand rehabilitation training).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Derkx to include determine a wearing state of the wearable device based on an intensity of the EMG signal and a quality of the second ECG signal, and output, to the user, a guide on the wearing state based on a result of the determination of Zhao in order to real time adjust and give scientific guidance (Zhao, page 6, ¶1).
While the combination of Derkx and Zhao teaches that the ECG/EMG signals obtained from the electrodes were filtered, amplified, digitized, and then transmitted (Zhao, page 13, ¶1), the combination fails to teach wherein the wearing state indicates a degree of contact between the wearable device and skin of the user.
Gunasekar relates generally to the field of electroencephalography and more specifically to a new and useful system and method for testing contact quality of electrical-biosignal electrodes (¶2). Gunasekar further teaches the invention using the following step:
wherein the wearing state indicates a degree of contact between the wearable device and skin of the user (¶13-generating an electrode adjustment prompt; ¶15-systematically characterize the quality of contact between electrodes—in the electrical biosignal acquisition system 100—and a user's skin and to automatically provide guidance for improving such contact quality).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Derkx to include wherein the wearing state indicates a degree of contact between the wearable device and skin of the user of Gunasekar in order to characterize the quality of contact between electrodes in the electrical biosignal acquisition system and a user's skin and to automatically provide guidance for improving such contact quality (Gunasekar, ¶15).
Regarding claim 3, the combination of Derkx, Zhao, and Gunasekar teaches the wearable device of claim 1, wherein the instructions, when executed by the at least one processor, further configured to, in response to the wearable device obtaining the second ECG signal: filter the EMG signal from the first ECG signal (Derkx, ¶6-applying a second high pass filter to the first EMG signal to generate a second EMG signal and to the ECG model signal to generate a second ECG model signal), and remove noise in addition to the EMG signal from the signal obtained by filtering the EMG signal, so as to obtain the second ECG signal (Derkx, ¶6-applying a second high pass filter to the first EMG signal to generate a second EMG signal and to the ECG model signal to generate a second ECG model signal).
Regarding claim 10, Derkx teaches a method performed by a wearable device, the method comprising: obtaining, by at least one processor of the wearable device (¶91-when executed on one or more processors and/or controllers, perform the required functions), a first ECG signal (¶6-obtaining a combined signal, wherein the combined signal comprises an ECG signal and an EMG signal; applying a first high pass filter to the combined signal; generating an ECG model signal based on the high pass filtered combined signal) using a first biometric sensor of the wearable device while the wearable device is worn on a user's body (¶63-two EMG electrodes 210 are provided at the second intercostal space of a user 220, with one electrode located at either side of the sternum; ¶64-the EMG electrodes detect a combined signal, containing EMG and ECG signals of the user); obtaining an EMG signal from the first ECG signal (¶6-obtaining a combined signal, wherein the combined signal comprises an ECG signal and an EMG signal; applying a first high pass filter to the combined signal; generating an ECG model signal based on the high pass filtered combined signal; generating a first EMG signal based on at least one of the ECG model signal); and obtaining a second ECG signal by filtering the EMG signal from the first ECG signal (¶6-applying a second high pass filter to the first EMG signal to generate a second EMG signal and to the ECG model signal to generate a second ECG model signal). However, Derkx does not teach determining, by the at least one processor of the wearable device, a wearing state of the wearable device based on an intensity of the EMG signal and a quality of the second ECG signals outputting, to the user, a guide on the wearing state based on a result of the determination, wherein the wearing state indicates a degree of contact between the wearable device and skin of the user.
Zhao teaches determining, by the at least one processor of the wearable device, a wearing state of the wearable device based on an intensity of the EMG signal and a quality of the second ECG signal (page 13, ¶1-the ECG/EMG signals obtained from the electrodes were filtered, amplified, digitized, and then transmitted to a remote receiver (i.e., smart phone or laptop) via the BLE module for further analysis; page 10, ¶1-upper limb muscle activity intensity could be detected and used for EMG monitoring in rehabilitation training; page 7, ¶1-the obtained data nearly approached the actual ECG signal and reliably; page 3, ¶3-a signal processor), and outputting, to the user, a guide on the wearing state based on a result of the determination (page 11, ¶1-a two-graph panel was designed to display the real-time graphical illustrations of the EMG and the ECG data; page 6, ¶1-the upper limb muscles (FCR and ECRL) are monitored by the EMG sensors, and the heart health status are monitored by the ECG sensor, which could real time adjust and give scientific guidance on control strategy for hand rehabilitation training).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Derkx to include determining, by the at least one processor of the wearable device, a wearing state of the wearable device based on an intensity of the EMG signal and a quality of the second ECG signal, and outputting, to the user, a guide on the wearing state based on a result of the determination of Zhao in order to real time adjust and give scientific guidance (Zhao, page 6, ¶1).
While the combination of Derkx and Zhao teaches that the ECG/EMG signals obtained from the electrodes were filtered, amplified, digitized, and then transmitted (Zhao, page 13, ¶1), the combination fails to teach wherein the wearing state indicates a degree of contact between the wearable device and skin of the user.
Gunasekar teaches wherein the wearing state indicates a degree of contact between the wearable device and skin of the user (¶13-generating an electrode adjustment prompt; ¶15-systematically characterize the quality of contact between electrodes—in the electrical biosignal acquisition system 100—and a user's skin and to automatically provide guidance for improving such contact quality).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Derkx to include wherein the wearing state indicates a degree of contact between the wearable device and skin of the user of Gunasekar in order to characterize the quality of contact between electrodes in the electrical biosignal acquisition system and a user's skin and to automatically provide guidance for improving such contact quality (Gunasekar, ¶15).
Regarding claim 13, the combination of Derkx, Zhao, and Gunasekar teaches the method of claim 10, wherein obtaining the second ECG signal comprises: passing the first ECG signal through a first filter (Derkx, ¶6-applying a first high pass filter to the combined signal); and passing the signal having passed through the first filter, through a second filter (Derkx, ¶6- applying a second high pass filter to the first EMG signal to generate a second EMG signal and to the ECG model signal to generate a second ECG model signal), and wherein the first filter and the second filter have different frequency bands (Derkx, ¶34-a first high pass filter with cutoff frequency of 5 Hz and a second high pass filter with cutoff frequency of 20 Hz).
Claims 2, 8, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Derkx in view of Zhao and Gunasekar as applied to claims 1 and 10 above, and further in view of Burnham (US 20140257049 filed on 2/26/14).
Regarding claim 2, the combination of Derkx, Zhao, and Gunasekar teaches the wearable device of claim 1 and a display (Zhao, page 10, last ¶-display area; Fig. 10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Derkx to include the display of Zhao in order to real time adjust and give scientific guidance (Zhao, page 6, ¶1).
While the combination of Derkx, Zhao, and Gunasekar teaches the display (Zhao, page 10, last ¶-display area; Fig. 10), the combination does not teach a housing configured to surround the display, wherein a first electrode among the plurality of electrodes is arranged on a bottom surface of the housing, and wherein a second electrode is arranged on a side surface or top surface of the housing.
Burnham teaches a housing configured to surround the display (¶10-housing 12; ¶12-LCD display 30; Fig. 1), wherein a first electrode among the plurality of electrodes is arranged on a bottom surface of the housing (Abstract-the ECG signal may be generated with an electrode mounted on the back of the housing; ¶13-the back portion 16 of the housing 12 may be formed primarily from conductive material, which provides a second electrode 32 of the ECG circuit), and wherein a second electrode is arranged on a side surface or top surface of the housing (¶12-a first electrode 28 of an ECG circuit, which is made from conductive material, is mounted on the front portion 14; Abstract-the ECG signal may be generated with an electrode mounted on the back of the housing and another electrode mounted on another portion of the housing, such as the back or one or more of the sides).
Burnham relates to a wearable heart monitoring apparatus (¶11).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Derkx to include a housing configured to surround the display, wherein a first electrode among the plurality of electrodes is arranged on a bottom surface of the housing, and wherein a second electrode is arranged on a side surface or top surface of the housing of Burnham in order to generate the ECG circuit in combination with the PPG signal to generate a blood pressure signal while a person touches a finger 60 to an electrode 32 positioned on the front surface 1 (Burnham, ¶10).
Regarding claim 8, the combination of Derkx, Zhao, and Gunasekar teaches the wearable device of claim 1. However, the combination of Derkx, Zhao, and Gunasekar does not teach a second biometric sensor having a light emitting module and a light receiving module, wherein the instructions, when executed by the at least one processor of the wearable device, are further configured to obtain a photoplethysmography (PPG) signal using the second biometric sensor while the wearable device is worn on the user’s body.
Burnham teaches a second biometric sensor having a light emitting module and a light receiving module, wherein the instructions, when executed by the at least one processor of the wearable device, are further configured to obtain a photoplethysmography (PPG) signal using the second biometric sensor while the wearable device is worn on the user’s body (Burnham, ¶13-the photo diode 40 and LED 44 are constructed and arranged such that the photo diode 40 only receives reflected light of the LED 44. The photo diode 40 generates a signal indicative of the reflected light from the person's skin that it receives. The photo diode 40 and LED 44 are part of a PPG circuit).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Derkx to include a second biometric sensor having a light emitting module and a light receiving module, wherein the instructions, when executed by the at least one processor of the wearable device, are further configured to obtain a photoplethysmography (PPG) signal using the second biometric sensor while the wearable device is worn on the user’s body of Burnham in order to be used in combination with the ECG signal to determine the user’s blood pressure (Burnham, ¶20).
Regarding claim 11, the combination of Derkx, Zhao, and Gunasekar teaches the method of claim 10. However, the combination of Derkx, Zhao, and Gunasekar does not teach wherein the wearable device comprises a display and a housing surrounding the display, wherein the first biometric sensor comprises a plurality of electrodes, wherein a first electrode among the plurality of electrodes is arranged on a bottom surface of the housing, and wherein a second electrode is arranged on a side surface or top surface of the housing.
Burnham teaches wherein the wearable device comprises a display (¶12-LCD display 30 in Fig. 1) and a housing surrounding the display (¶10-housing 12; ¶12-LCD display 30; Fig. 1), wherein the first biometric sensor comprises a plurality of electrodes (¶16-electrodes), wherein a first electrode among the plurality of electrodes is arranged on a bottom surface of the housing (Abstract-the ECG signal may be generated with an electrode mounted on the back of the housing; ¶13-the back portion 16 of the housing 12 may be formed primarily from conductive material, which provides a second electrode 32 of the ECG circuit), and wherein a second electrode is arranged on a side surface or top surface of the housing (¶12-a first electrode 28 of an ECG circuit, which is made from conductive material, is mounted on the front portion 14; Abstract-the ECG signal may be generated with an electrode mounted on the back of the housing and another electrode mounted on another portion of the housing, such as the back or one or more of the sides).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Derkx to include wherein the wearable device comprises a display and a housing surrounding the display, wherein the first biometric sensor comprises a plurality of electrodes, wherein a first electrode among the plurality of electrodes is arranged on a bottom surface of the housing, and wherein a second electrode is arranged on a side surface or top surface of the housing of Burnham in order to generate the ECG circuit in combination with the PPG signal to generate a blood pressure signal while a person touches a finger 60 to an electrode 32 positioned on the front surface 1 (Burnham, ¶10).
Regarding claim 12, the combination of Derkx, Zhao, Gunasekar, and Burnham teaches the method of claim 11, wherein the first electrode is arranged on the display (Burnham, ¶12-a first electrode 28 of an ECG circuit, which is made from conductive material, is mounted on the front portion 14; Abstract-the ECG signal may be generated with an electrode mounted on the back of the housing and another electrode mounted on another portion of the housing, such as the back or one or more of the sides), and the second electrode is arranged on a portion of the housing (Burnham, Abstract-the ECG signal may be generated with an electrode mounted on the back of the housing; ¶13-the back portion 16 of the housing 12 may be formed primarily from conductive material, which provides a second electrode 32 of the ECG circuit).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Derkx to include wherein the first electrode is arranged on the display, and the second electrode is arranged on a portion of the housing of Burnham in order to generate the ECG circuit in combination with the PPG signal to generate a blood pressure signal while a person touches a finger 60 to an electrode 32 positioned on the front surface 1 (Burnham, ¶10).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Derkx in view of Zhao and Gunasekar as applied to claim 1 above, and further in view of Eom (US 20160198977 filed on 6/25/15 as cited in the IDS).
Regarding claim 16, the combination of Derkx, Zhao, and Gunasekar teaches the wearable device of claim 1. However, the combination of Derkx, Zhao, and Gunasekar does not teach a bioelectrical impedance analysis (BIA) sensor.
Eom teaches a bioelectrical impedance analysis (BIA) sensor (¶56-a measuring unit 140 configured to measure a bio impedance of the subject).
Eom relates to a wearable apparatus for obtaining biological information and method of obtaining biological information using the same (¶3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Derkx to include a bioelectrical impedance analysis (BIA) sensor of Eom in order to determine correction factors with regard to the measured bio signal in response to the detected position (Eom, ¶9).
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.
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/L.N.H./Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792