DETAILED ACTION
This action is pursuant to the RCE filed on 10/2/2025. Claims 1-7 and 9-20 are pending, claim 8 has been cancelled by the applicant. A non-final action on the merits of claims 1-7 and 9-20 is as follows.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/2/2025 has been entered.
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 12 and 20 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.
Claim 12 is rejected as indefinite because “aggregate the electrical signals by averaging the electrical signals captured at each of the plurality of in-ear electrodes” is indefinite. It is unclear whether the “plurality of in-ear electrodes” is meant to be a plurality of in-ear electrodes on the second in-ear device, or be the “plurality of in-ear electrodes” introduced in claim 1. Because the limitation of the processor aggregating the electrical signals was introduced in claim 1 as it related to the first in-ear device, it appears that the clause in claim 12 is referring to the second in-ear device. However, there is insufficient antecedent basis in claim 12 for a “plurality of in-ear electrodes” on the second in-ear device as claim 12 only introduces “at least one in-ear electrode.” Therefore, because it is unclear whether the processor is aggregating the signals from the second in-ear electrodes or the first in-ear electrodes, the claim is rejected. For the purposes of compact prosecution, this will be interpreted as the processor aggregating the electrical signals of the second in-ear electrodes.
Claim 20 is rejected because “the plurality of in-ear electrodes” lacks antecedent basis. Claim 20 does not introduce in-ear electrodes. Nor does claim 20 introduce a “plurality” of electrodes. Claim 20 simply introduces “at least a first electrode configured to contact a surface of a user’s head.” Therefore, the claim is rejected because “the plurality of in-ear electrodes” lacks antecedent basis. For the purposes of compact prosecution, this will be interpreted as a plurality of first electrodes.
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) 1-7, 9-11, 13-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Savchenko (WO 2021150148 A1) in view of Chou et al. (hereinafter ‘Chou’, US 20180020937 A1) and in further view of Nielsen et al. (hereinafter ‘Nielsen’, US 20200196073 A1).
Regarding independent claim 1, Savchenko discloses a system (system shown in Figs. 1 and 3 where the system shown Fig. 1 is a block diagram and Fig 3 illustrates a physical embodiment), comprising:
an in-ear device (ear piece 300 in Fig. 3) comprising:
an in-ear electrode (electrode 303 in Fig. 3) configured to contact an inner surface of a user's ear when the in-ear device is worn by the user ([0049]: the cover 303 serves the purpose of the electrode 207 in Fig. 2; [0046]: cover 207 is positioned in the concha of the ear and touches the skin of the concha and serves a purpose of the first electrode 103 in Fig. 1);
an out-of-ear electrode (electrode 317 in Fig. 3) configured to not contact a surface of the ear of the user when the in-ear device is worn by the user ([0050]: the electrode 317 serves the purpose of the second electrode 203 in Fig. 2; [0047]: the electrode 203 is placed on the outer surface of the earpiece, facing out of the ear of the user and serves the purpose of a second electrode 104 in Fig. 1); and
a processor (microcontroller 113 in the HRM subsystem in Fig. 1) configured to:
determine that a finger of a fist hand of the user is contacting the out-of-ear electrode ([0063]-[0064]: when the user places a finger on the second electrode it triggers the HRM subsystem to turn on. This is accomplished by the MCU detecting the ECG pattern and once a quality pattern is detected, the system turns on and notifies the user that an ECG is detected and to hold the finger tight; [0064]: the first thread of Fig. 8 is also illustrated on Fig. 1 connecting the AFE 109 and the MCU 113);
responsive to determining that the finger of the first hand is contacting the out-of-ear electrode, capture electrical signals corresponding to a heartbeat of the user at the at least one in-ear electrode and the out-of-ear electrode ([0063]-[0064]: when the user places a finger on the second electrode it triggers the HRM subsystem to turn on. This is accomplished by the MCU detecting the ECG pattern and once a quality pattern is detected, the system turns on and notifies the user that an ECG is detected and to hold the finger tight); and
generate electrocardiogram (ECG) data based upon the captured electrical signals ([0064]: the HRM subsystem calculates the heart activity and starts calculating the heart activity parameters).
Savchenko further discloses the use of the two electrodes to function as a single lead ([0038]) where the out of ear electrode is capable of being touched by fingers of either hand, which imparts the capability to measure along different viewing vectors (inherent property of the device – the device only relies on being touched by one finger and the user can easily switch fingers; this is similar to the function of the instant application which in paragraph [0043] states the user can use their left hand or right hand to create different viewing vectors)
However, Savchenko is silent to the processor utilizing the different viewing vectors to construct the user’s ECG profile.
Chou teaches an ear worn device with an in-ear electrode and an out-of-ear electrode used to capture ECG signals ([0122] and Figs. 5A-5B and 6B1-6B2). The first electrode 10 is located on the in-ear side as shown in Fig. 6B2 and the second electrode 12 is on the outside as shown in Fig. 6B1. In order for the ECG data to be acquired, the user only needs to touch the outer electrode with their finger when the device is worn ([0075] and shown in Fig. 5B). Chou further teaches that obtaining electrocardiograms at different angles allows for a more comprehensive view of the heart because the heart is a three-dimensional organ ([0066]). Utilizing the different angles allows for a more accurate judgement of the heart disease ([0066]). Utilizing different angles, which correspond to creating different leads or viewing vectors is a known process in the art to create a more accurate picture of the user’s heart and Savchenko is capable of sensing at these different angles because the user can simply switch which finger contacts the electrode, consistent with the process of the instant application. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Savchenko such that it processes, analyzes, and stores data of the user (which creates the user’s profile) at different viewing vectors, or angles, to generate a more complete picture of the heart to better diagnose the heart issues.
However, the Sachenko/Chou combination does not disclose the in-ear device comprising a plurality of in-ear electrodes that contact different locations in the user’s ear wherein the processor aggregates the electrical signals by averaging the signals captured at each of the in-ear electrodes to generate an overall electrical signal.
The Savchenko/Chou combination discloses the cover of the in-ear piece 303 in Fig. 3 serves as an electrode for detecting ECG signals ([0049]). The Savchenko/Chou combination further discloses the potential for a third electrode on the earpiece that contacts the skin of the earlobe ([0048]). The signals of both of these are sent to the processor for processing as seen in Fig. 1 (Fig. 1 shows signals from all three electrodes going to the MCU for processing).
Nielsen teaches an earpiece for a hearing device that includes sensors configured to measure a physiological parameter ([Abstract]). The primary sensor can receive physiological parameters such as ECG ([0027]). Nielsen further teaches that the earpiece can contain secondary, tertiary, or any number of subsequent sensors that can be used to increase the signal quality of the measurement ([0039]). These electrodes would contact different portions of the ear canal as seen in Figs. 4b and 4c. The signal quality of the measurement can be improved by averaging the signals relative to each other, which would in turn generate an overall electrical signal ([0039]). It would be routine for one of ordinary skill in the art to include multiple electrodes on the cover of the in-ear piece that would have their signals aggregated as Savchenko has disclosed the potential for including multiple electrodes that have all of their signals processed by the same processor and Nielsen teaches embodiments that can include a single primary sensor or multiple sensors which have their signals averaged together. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the multiple in-ear sensors of Nielsen with the Savchenko/Chou combination such that the signal quality of the measurement is improved by averaging the signals relative to each other, thus arriving at the claimed invention.
Regarding claim 2, the Savchenko/Chou/Nielsen combination discloses the system of claim 1, wherein the out-of-ear electrode is located on an outer surface of the in-ear device and configured to face away from the user's head when the in-ear device is worn by the user (the electrode 317 in Fig. 3 is on the outside of the earpiece and electrode 405 in Fig. 4, which is the same as electrode 317, is facing away from the user’s head when the device is in use as seen in Fig. 4A).
Regarding claim 3, the Savchenko/Chou/Nielsen combination discloses the system of claim 1, wherein the processor is configured to capture electrical signals corresponding to the heartbeat at the at least one in-ear electrode and the out-of-ear electrode over at least a threshold period of time ([0063]-[0064]: when the first electrode is in the ear and the finger is placed on the second electrode, the system starts to collect ECG data and calculates heart activity parameters. Once sufficient heart activity parameters are calculated, the subsystem notifies the user that measurement is completed; this statement discloses that the threshold period of time is the time it takes to collect ample information on the condition).
Regarding claim 4, the Savchenko/Chou/Nielsen combination discloses the system of claim 1, wherein the processor is further configured to determine a heart rate of the user based upon the generated ECG data ([0064]: the HRM subsystem calculates hear activity parameters from ECG data such as heart rate variability).
Regarding claim 5, the Savchenko/Chou/Nielsen combination discloses the system of claim 1, wherein the generated ECG data comprises first ECG data generated by the processor during a first time period ([0064]: the system collect data and when a quality ECG data is detected, it notifies the user to hold their finger tight; i.e. the first period of time and the first ECG data is that when there is either no finger contact or poor finger contact), and wherein processor is further configured to generate second ECG data based upon captured electrical signals at the at least one in-ear electrode and the out-of-ear electrode during a second time period, responsive to determining that that the user is contacting the out-of-ear electrode using a finger of a second hand of the user ([0064]: when quality contact of the finger is determined, the subsystem starts calculating the heart activity parameters; the finger making the quality contact is not limited so it could be a right hand finger or left hand finger).
Regarding claim 6, the Savchenko/Chou/Nielsen combination discloses the system of claim 1, wherein the in-ear device further comprises an audio transducer ([0037]: the HRM subsystem can include an audio subsystem) configured to provide audio messages to the user ([0064]: the device can provide a voice message “ECG is detected. Hold your finger tight”).
Regarding claim 7, the Savchenko/Chou/Nielsen combination discloses the system of claim 6, wherein the audio transducer is configured to prompt the user to contact the out-of-ear electrode with the finger ([0064]: the device provides a voice message “ECG is detected. Hold your finger tight”).
Regarding claim 9, the Savchenko/Chou/Nielsen combination discloses the system of claim 1, wherein at least a portion of the processor is located in the in-ear device (the processor 113 is located inside of the earpiece 101 as seen in Fig. 1; [0038]: the earpiece contains the MCU).
Regarding claim 10, the Savchenko/Chou/Nielsen combination discloses the system of claim 1, wherein the processor is located in a headset ([0023]: the embodiments are presented with reference to a headset; [0029]: the headset is the device is a device that comprises at least one headphone; [0038]: the headphone/earpiece contains the MCU).
Regarding claim 11, the Savchenko/Chou/Nielsen combination discloses the system of claim 1, wherein the in-ear device further comprises a signal processor (AFE 109 in Fig. 1) configured to amplify a voltage difference between the electrical signals captured at the at least one in-ear electrode and at the out-of-ear electrode (the electrodes 103 and 104 are connected to the input of AFE 109, the output of which is an amplified analog signal to be passed to the microcontroller).
Regarding claim 12, the Savchenko/Chou/Nielsen combination discloses the invention substantially in claim 1 and described above. Savchenko further discloses that the present invention relates to a headset for heart activity monitoring ([0023]). Savchenko further discloses that the headset can be made with either a single ear-piece or a double-earpiece ([0029]). Savchenko further discloses a generic earbud with an in-ear and out-of-ear electrode with a processor that determines whether a finger is in a contact state with the out of ear electrode which triggers the collection of ECG data, as explained above.
However, the Savchenko/Chou/Nielsen combination does not explicitly state that in an embodiment with two ear-pieces, the second ear piece contains in-ear and out-of-ear electrodes and a processor that begins recording ECG data when a second finger touches the second electrode and wherein the processor aggregates the electrical signals by averaging the electrical signals captured at each of the plurality of second in-ear electrodes to generate an overall electrical signal.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to duplicate the electrodes and processor of the first ear bud into the second earbud, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Duplicating the first ear bud would impart an in-ear and out-of-ear electrode with a processor configured to detect a finger to trigger ECG collection onto the second earbud wherein the processor aggregates the electrical signals by averaging the electrical signals captured at each of the plurality of second in-ear electrodes to generate an overall electrical signal, thus arriving at the claimed invention.
Regarding independent claim 20, Savchenko discloses a headset ([0023]: the embodiments are presented with reference to a headset), comprising:
at least a first electrode configured (electrode 303 in Fig. 3) to contact a surface of a user's head when the headset is worn by the user ([0049]: the cover 303 serves the purpose of the electrode 207 in Fig. 2; [0046]: cover 207 is positioned in the concha of the ear and touches the skin of the concha, which is on the surface of the head, and serves a purpose of the first electrode 103 in Fig. 1);
a second electrode (electrode 317 in Fig. 3) configured to not contact a surface of the user's head when the headset is worn by the user ([0050]: the electrode 317 serves the purpose of the second electrode 203 in Fig. 2; [0047]: the electrode 203 is placed on the outer surface of the headset, facing away from the head of the user and serves the purpose of a second electrode 104 in Fig. 1); and
a processor (microcontroller 113 in the HRM subsystem in Fig. 1) configured to:
determine that a finger of a first hand of the user is contacting the second electrode ([0063]-[0064]: when the user places a finger on the second electrode it triggers the HRM subsystem to turn on. This is accomplished by the MCU detecting the ECG pattern and once a quality pattern is detected, the system turns on and notifies the user that an ECG is detected and to hold the finger tight; [0064]: the first thread of Fig. 8 is also illustrated on Fig. 1 connecting the AFE 109 and the MCU 113);
responsive to determining that the finger of the first hand is contacting the second electrode, capture electrical signals corresponding to a heartbeat of the user at the at least one first electrode and the second electrode ([0063]-[0064]: when the user places a finger on the second electrode it triggers the HRM subsystem to turn on. This is accomplished by the MCU detecting the ECG pattern and once a quality pattern is detected, the system turns on and notifies the user that an ECG is detected and to hold the finger tight); and
generate electrocardiogram (ECG) data based upon the captured electrical signals ([0064]: the HRM subsystem calculates the heart activity and starts calculating the heart activity parameters).
Savchenko further discloses the use of the two electrodes to function as a single lead ([0038]) where the out of ear electrode is capable of being touched by fingers of either hand, which imparts the capability to measure along different viewing vectors (inherent property of the device – the device only relies on being touched by one finger and the user can easily switch fingers; this is similar to the function of the instant application which in paragraph [0043] states the user can use their left hand or right hand to create different viewing vectors)
However, Savchenko is silent to the processor utilizing the different viewing vectors to construct the user’s ECG profile.
Chou teaches an ear worn device with an in-ear electrode and an out-of-ear electrode used to capture ECG signals ([0122] and Figs. 5A-5B and 6B1-6B2). The first electrode 10 is located on the in-ear side as shown in Fig. 6B2 and the second electrode 12 is on the outside as shown in Fig. 6B1. In order for the ECG data to be acquired, the user only needs to touch the outer electrode with their finger when the device is worn ([0075] and shown in Fig. 5B). Chou further teaches that obtaining electrocardiograms at different angles allows for a more comprehensive view of the heart because the heart is a three-dimensional organ ([0066]). Utilizing the different angles allows for a more accurate judgement of the heart disease ([0066]). Utilizing different angles, which correspond to creating different leads or viewing vectors is a known process in the art to create a more accurate picture of the user’s heart and Savchenko is capable of sensing at these different angles because the user can simply switch which finger contacts the electrode, consistent with the process of the instant application. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Savchenko such that it processes, analyzes, and stores data of the user (which creates the user’s profile) at different viewing vectors, or angles, to generate a more complete picture of the heart to better diagnose the heart issues.
However, the Sachenko/Chou combination does not disclose the device comprising a plurality of first electrodes wherein the processor aggregates the electrical signals by averaging the signals captured at each of the first electrodes to generate an overall electrical signal.
The Savchenko/Chou combination discloses the cover of the in-ear piece 303 in Fig. 3 serves as an electrode for detecting ECG signals ([0049]). The Savchenko/Chou combination further discloses the potential for a third electrode on the earpiece that contacts the skin of the earlobe ([0048]). The signals of both of these are sent to the processor for processing as seen in Fig. 1 (Fig. 1 shows signals from all three electrodes going to the MCU for processing).
Nielsen teaches an earpiece for a hearing device that includes sensors configured to measure a physiological parameter ([Abstract]). The primary sensor can receive physiological parameters such as ECG ([0027]). Nielsen further teaches that the earpiece can contain secondary, tertiary, or any number of subsequent sensors that can be used to increase the signal quality of the measurement ([0039]). The signal quality of the measurement can be improved by averaging the signals relative to each other, which would in turn generate an overall electrical signal ([0039]). It would be routine for one of ordinary skill in the art to include multiple electrodes on the device that would have their signals aggregated as Savchenko has disclosed the potential for including multiple electrodes that have all of their signals processed by the same processor and Nielsen teaches embodiments that can include a single primary sensor or multiple sensors which have their signals averaged together. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the multiple sensors of Nielsen with the Savchenko/Chou combination such that the signal quality of the measurement is improved by averaging the signals relative to each other, thus arriving at the claimed invention.
Claim(s) 13-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Savchenko (WO 2021150148 A1) in view of Chou et al. (hereinafter ‘Chou’, US 20180020937 A1)
Regarding independent claim 13, Savchenko discloses a method (methods shown in Figs. 7-9), comprising:
an in-ear device (ear piece 300 in Fig. 3; [0063]: Fig. 8 is a block diagram illustrating the logic of the heart monitoring sensor in the ear piece) comprising at least one in-ear electrode (electrode 303 in Fig. 3) configured to contact an inner surface of a user's ear when the in-ear device is worn by the user ([0049]: the cover 303 serves the purpose of the electrode 207 in Fig. 2; [0046]: cover 207 is positioned in the concha of the ear and touches the skin of the concha and serves a purpose of the first electrode 103 in Fig. 1) and an out-of- ear electrode (electrode 317 in Fig. 3) configured to not contact a surface of the ear of the user when the in- ear device is worn by the user ([0050]: the electrode 317 serves the purpose of the second electrode 203 in Fig. 2; [0047]: the electrode 203 is placed on the outer surface of the earpiece, facing out of the ear of the user and serves the purpose of a second electrode 104 in Fig. 1), determining that a finger of a first hand of the user is contacting the out-of-ear electrode ([0063]-[0064]: when the user places a finger on the second electrode it triggers the HRM subsystem to turn on. This is accomplished by the MCU detecting the ECG pattern and once a quality pattern is detected, the system turns on and notifies the user that an ECG is detected and to hold the finger tight; [0064]: the first thread of Fig. 8 is also illustrated on Fig. 1 connecting the AFE 109 and the MCU 113);
responsive to determining that the finger of the first hand of the user is contacting the out-of-ear electrode, capturing electrical signals corresponding to a heartbeat of the user at the at least one in-ear electrode and the out-of-ear electrode ([0063]-[0064]: when the user places a finger on the second electrode it triggers the HRM subsystem to turn on. This is accomplished by the MCU detecting the ECG pattern and once a quality pattern is detected, the system turns on and notifies the user that an ECG is detected and to hold the finger tight); and
generating electrocardiogram (ECG) data based upon the captured electrical signals ([0064]: the HRM subsystem calculates the heart activity and starts calculating the heart activity parameters).
Savchenko further discloses the use of the two electrodes to function as a single lead ([0038]) where the out of ear electrode is capable of being touched by fingers of either hand, which imparts the capability to measure along different viewing vectors (inherent property of the device – the device only relies on being touched by one finger and the user can easily switch fingers; this is similar to the function of the instant application which in paragraph [0043] states the user can use their left hand or right hand to create different viewing vectors)
However, Savchenko is silent to the processor utilizing the different viewing vectors to construct the user’s ECG profile.
Chou teaches an ear worn device with an in-ear electrode and an out-of-ear electrode used to capture ECG signals ([0122] and Figs. 5A-5B and 6B1-6B2). The first electrode 10 is located on the in-ear side as shown in Fig. 6B2 and the second electrode 12 is on the outside as shown in Fig. 6B1. In order for the ECG data to be acquired, the user only needs to touch the outer electrode with their finger when the device is worn ([0075] and shown in Fig. 5B). Chou further teaches that obtaining electrocardiograms at different angles allows for a more comprehensive view of the heart because the heart is a three-dimensional organ ([0066]). Utilizing the different angles allows for a more accurate judgement of the heart disease ([0066]). Utilizing different angles, which correspond to creating different leads or viewing vectors is a known process in the art to create a more accurate picture of the user’s heart and Savchenko is capable of sensing at these different angles because the user can simply switch which finger contacts the electrode, consistent with the process of the instant application. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Savchenko such that it processes, analyzes, and stores data of the user (which creates the user’s profile) at different viewing vectors, or angles, to generate a more complete picture of the heart to better diagnose the heart issues.
Regarding claim 14, the Savchenko/Chou combination discloses the method of claim 13, wherein the out-of-ear electrode is located on an outer surface of the in-ear device and configured to face away from the user's head when the in-ear device is worn by the user (the electrode 317 in Fig. 3 is on the outside of the earpiece and electrode 405 in Fig. 4, which is the same as electrode 317, is facing away from the user’s head when the device is in use as seen in Fig. 4A).
Regarding claim 15, the Savchenko/Chou combination discloses the method of claim 13, further comprising capturing electrical signals corresponding to the heartbeat of the user at the at least one in-ear electrode and the out-of-ear electrode over at least a threshold period of time ([0063]-[0064]: when the first electrode is in the ear and the finger is placed on the second electrode, the system starts to collect ECG data and calculates heart activity parameters. Once sufficient heart activity parameters are calculated, the subsystem notifies the user that measurement is completed; this statement discloses that the threshold period of time is the time it takes to collect ample information on the condition).
Regarding claim 16, the Savchenko/Chou combination discloses the method of claim 13, further comprising determining a heart rate of the user based upon the generated ECG data ([0064]: the HRM subsystem calculates hear activity parameters from ECG data such as heart rate variability).
Regarding claim 17, the Savchenko/Chou combination discloses the method of claim 13, wherein the generated ECG data comprises first ECG data generated during a first time period ([0064]: the system collect data and when a quality ECG data is detected, it notifies the user to hold their finger tight; i.e. the first period of time and the first ECG data is that when there is either no finger contact or poor finger contact), and further comprising generating second ECG data based upon captured electrical signals at the at least one in-ear electrode and the out-of-ear electrode during a second time period, responsive to determining that that the user is contacting the out-of-ear electrode using a finger of a second hand of the user ([0064]: when quality contact of the finger is determined, the subsystem starts calculating the heart activity parameters; the finger making the quality contact is not limited so it could be a right hand finger or left hand finger).
Regarding claim 19, the Savchenko/Chou combination discloses the method of claim 13, further comprising amplifying a voltage difference between the electrical signals captured at the at least one in-ear electrode and at the out-of-ear electrode (the electrodes 103 and 104 are connected to the input of AFE 109, the output of which is an amplified analog signal to be passed to the microcontroller).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over the Savchenko/Chou combination as applied to claims 1 and 13 respectively and described above, in view of Kirszenblat et al. (hereinafter ‘Kirszenblat’, US 20180235540 A1).
Regarding claim 18, the Savchenko/Chou combination discloses the cover of the in-ear piece 303 in Fig. 3 serves as an electrode for detecting ECG signals ([0049]). The Savchenko/Chou combination further discloses the potential for a third electrode on the earpiece that contacts the skin of the earlobe ([0048]). The signals of both of these are sent to the processor for processing as seen in Fig. 1 (Fig. 1 shows signals from all three electrodes going to the MCU for processing).
However, the Savchenko/Chou combination does not disclose the cover comprising a plurality of in-ear electrodes that have their signals aggregated.
Kirszenblat teaches a method for obtaining biological information via an electrode on an ear tip of an earpiece that is inserted into the user’s ear configured to derive ECG data ([Abstract]). Kirszenblat further teaches that the earpiece 800 can have any integer number of conductive coatings which serve as individual electrodes. Having multiple electrodes is useful to compute ECG as differences of potential. Additionally, having several sections wherein each section acts as a separate electrode improves the signal to noise ration be removing uncorrelated noise ([0077]). It would be routine for one skilled in the art to include multiple electrodes on the cover of the in-ear piece that would have their signals aggregated as Savchenko has disclosed the potential for including multiple electrodes that have all of their signals processed by the same processor. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the multiple electrodes of Kirszenblat with the electrode cover and processor of Savchenko such that each section of the cover has its own electrode to aid in computing accurate ECG signals and improving the signal to noise ratio, thus arriving at the claimed invention.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 12, and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The rejections of the dependent claims are maintained because the rejections of the independent claims are maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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, Linda Dvorak can be reached at (571)272-4764. 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.
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./Examiner, Art Unit 3794