DETAILED ACTION
This action is pursuant to claims filed on 6/4/2026. Claims 1-13 are pending. A final action on the merits of claims 1-13 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 .
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) 1-4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Tarler (US 9693732 B1) in view of Chi et al. (hereinafter ‘Chi’, US 20130300435 A1), and in further Varadan (US 20110251469 A1).
Regarding independent claim 1, Tarler discloses a wireless electroencephalogram (EEG) recording system ([Col 5, lines 47-58]: electrode patch and wireless system can be used for EEG), comprising: a set of electrodes ([Col 5, line 59-Col 6, line 8]: the device contains multiple electrodes for sensing physiological channels with at least two electrical pathways connected to the electrodes – see Figs. 1-3) including two electrodes placed orthogonally with respect to a common electrode (as seen in Fig. 2, two electrodes 14 can be moved to be placed orthogonally relative to reference electrode 15; [Col 16, lines 1-25]: the electrodes are connected to flexible arms which allow for versatility in electrode placement), configured to detect EEG data across two channels ([Claim 3]: the electrode amplifier is adapted to detect at least two channels of at least one type of electrophysiological signal from the at least two electrodes – thus there is collection across at least two channels); an analog-to-digital converter (ADC) configured to capture the EEG data detected by the set of electrodes ([Col 9, lines 6-16]: the physiological signal is converted to a digital form through an ADC); a digital controller ([Col 9, lines 17-49]: the device contains a microcontroller for digital processing), and generate a packet ([Col 9, lines 17-49]: the microcontroller generates the RF data stream; [Col 9, lines 50-65]: the data is sent in a data packet format resulting in minimal distortion – thus it is inherently packetized prior to being sent); and a radio frequency (RF) transmitter ([Col 10, lines 60-61]: the circuitry comprises an RF transmitter) configured to transmit the packet to an external receiver ([Col 17, lines 44-65]: the electronic components transmit the signal to a receiving unit or remote communications station or device).
While Tarler is capable of sensing two spatially orthogonal EEG signals due to the variability in electrode placement, Tarler does not explicitly disclose that the two channels of collected data are two spatially orthogonal EEG signals.
Chi teaches an electric field sensor including multiple sensing electrodes ([Abstract]). The sensor can be used to collect EEG signals, similar to the device of Tarler ([0054]). Chi further teaches an electric field sensor as shown in Fig. 7. This electric field sensor contains a plurality of electrodes that form orthogonal pairs ([0044]). Measuring across orthogonal pairs allows for a 2-D local spatial electric field to be determined ([0044]). Modifying the device of Tarler to ensure that the electrodes placed orthogonally with respect to the common electrode detect two spatially orthogonal signals would be an obvious modification in view of Chi. 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 combine the teachings of Chi with Tarler such that the electrode placed orthogonally with respect to the reference electrode measure two spatially orthogonal EEG signals which would ensure that the 2-D spatial field of the EEG signal is accurately determined.
However, the Tarler/Chi combination does not explicitly state the digital controller is configured to encode the captured EEG data into a single-bit series and generate a packet using the single bit series.
Varadan teaches a wireless system for neurological and physiological monitoring of a patient ([Abstract]). The system provides for unobtrusive measurement of numerous biological parameters, including EEG ([0042]). Similar to Tarler, the sensors and electrodes are interfaced to an ADC ([0047]). The analog input channels are sampled, formatted, and data packets are created for transmission ([0049]). In order to send the data, the data is serialized, which means the data is encoded into a single-bit series, and packetized for reliable transmission ([0071]). 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 serialization and packetization taught by Varadan with the controller of Tarler such that the data is transmitted reliably and error-free ([0071]).
Regarding claim 2, the Tarler/Chi/Varadan combination discloses the wireless EEG recording system of claim 1, further comprising a battery powering the ADC, the digital controller, and the RF transmitter ([Col 8, lines 18-36]: the circuitry of the one or more electronic components is powered by a battery).
Regarding claim 3, the Tarler/Chi/Varadan combination discloses the wireless EEG recording system of claim 2, further comprising an adhesive patch configured to be attached to a head of a patient ([Col 7, lines 28-34]: the electrode patch is attached to the body by an adhesive on the lower surface of the base; “configured to be attached to the head” is a functional limitation that the Tarler/Chi/Varadan combination is capable of since it has adhesive and can be used for EEG, which is measured on the head), wherein the set of electrodes, a chip including the ADC, the digital controller and the RF transmitter, and the battery are each attached to the adhesive patch (Figs. 1, 3, and 9; [Col 15, lines 27-55]: the electrode patch comprises an adhesive on which a base 12 and the electrodes 14 are disposed; [Col 17, line 44-Col 18, line 5]: the electrode patch further comprises the one or more electrical components 34 and the battery; [Col 9, lines 17-49], [Col 10, lines 60-65], & [Col 18, lines 6-19]: the electrical components include the ADC, microcontroller, and transmitter as seen in Fig. 10).
Regarding claim 4, the Tarler/Chi/Varadan combination discloses the wireless EEG recording system of claim 2, wherein the battery operates using 1.2 - 1.8 V ([Col 8, lines 18-36]: the preferred battery of the invention are zinc-air hearing aid batteries, preferably a three-cell stack of zinc-air batteries, each cell offering a steady 1.2V – the claim does not limit that the device can’t have more than one battery and each battery operates at the claimed 1.2V).
Regarding claim 13, the Tarler/Chi/Varadan combination discloses the wireless EEG recording system of claim 1,wherein the wireless EEG recording system is located a distance less than or equal to 10 m from the external receiver ([Col 15, lines 12-20]: the remote communication station can pick up and transmit signals from distances greater than about 5ft from the subject, or greater than 10 feet from the subject, or greater than 20ft from the subject, or greater than 50ft from the subject, or from greater than 200ft from the subject – all of these are less than 10m; furthermore, this is simply a matter of how close the patient is positioned to the external receiver during measurement and the patient can be easily placed under 10m from the receiver for transmission).
Claim(s) 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over the Tarler/Chi/Varadan combination as applied to claim 2/1 and described above, in view of Howard (US 20220118258 A1).
Regarding claim 5, the Tarler/Chi/Varadan combination discloses the wireless EEG recording system of claim 2 as described above. Tarler further discloses that the circuitry of the electronic components can be modified to function with any suitable miniature DC power source like a DC battery ([Col 8, lines 18-36]).
However, the Tarler/Chi/Varadan combination is silent to the provided power.
Howard teaches a brain monitoring and stimulation device comprising an array of multifunctional cells of circuitry ([Abstract]). The device may be used for EEG, similar to the device of the Tarler/Chi/Varadan combination ([0185]). Howard further teaches that the device may include a battery, and based on the size needed, the battery may be external to the headset or fit in the headset band ([0186]). These batteries can be rechargeable and replaceable Li-Po batteries ([0276]). The rechargeable Li-Po batteries have a power budget of 500µW for the same volume as other battery types ([0334]). Thus, the Li-Po batteries are both rechargeable and have a high power density for their small size, since they can be used in pacemakers ([0334]). Furthermore, substituting the Li-Po battery for the zinc-air battery is a simple substitution that is well within the ordinary level of skill in the art. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the Li-Po battery of Howard for the zinc-air battery of the Tarler/Chi/Varadan combination in order to provide a battery that is small, rechargeable, and has a high power density.
Regarding claim 6, the Tarler/Chi/Varadan combination discloses the wireless EEG recording system claim 2 as described above. Tarler further discloses that the circuitry of the electronic components can be modified to function with any suitable miniature DC power source like a DC battery ([Col 8, lines 18-36]).
However, the Tarler/Chi/Varadan combination is silent to the total load capacity of the battery.
Howard teaches a brain monitoring and stimulation device comprising an array of multifunctional cells of circuitry ([Abstract]). The device may be used for EEG, similar to the device of the Tarler/Chi/Varadan combination ([0185]). Howard further teaches that the device may include a battery, and based on the size needed, the battery may be external to the headset or fit in the headset band ([0186]). These batteries can be rechargeable and replaceable Li-Po batteries ([0276]). The rechargeable Li-Po batteries promise about 36mWh which equates to a power budget of 500µW for the same volume as other battery types ([0334]). Thus, the Li-Po batteries are both rechargeable and have a high power density for their small size, since they can be used in pacemakers ([0334]). Furthermore, substituting the Li-Po battery for the zinc-air battery is a simple substitution that is well within the ordinary level of skill in the art. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the Li-Po battery of Howard for the zinc-air battery of the Tarler/Chi/Varadan combination in order to provide a battery that is small, rechargeable, and has a high power density.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over the Tarler/Chi/Varadan combination as applied to claim 1 and described above, in view of Nielsen et al. (hereinafter ‘Nielsen’, US 20170311097 A1) and in further view of Kim et al. (hereinafter ‘Kim’, US 20150216481 A1).
Regarding claim 7, the Tarler/Chi/Varadan combination discloses the wireless EEG recording system of claim 1, wherein each recording channel, of the two-channel electrodes, is 12-bit ([Col 9, lines 6-16]: preferably, the ADC restricts resolution to 12-bits).
However, the Tarler/Chi/Varadan combination is silent to the recording channels being 33-kHz ADC channels.
Nielsen teaches a hearing aid comprising an electrode for detecting a physiological signal from the subject ([Abstract]). The physiological signal detected can be EEG, similar to the device of the Tarler/Chi/Varadan combination ([0007]). The physiological response is recorded as an analog signal and converted to a digital signal using an ADC, just like the Tarler/Chi/Varadan combination. The ADC samples the analog signal with a predefined sampling frequency in the range from 0.5 kHz to 48kHz which is adapted to the particular signals or the needs of the application ([0033]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to utilize a sampling frequency of 33kHz, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Furthermore, the instant application provides no criticality to this frequency and Nielsen clearly teaches that the sampling frequency can be selected based on the particular signal and the needs of the application.
However, the Tarler/Chi/Varadan/Nielsen combination does not explicitly state the type of ADC.
Kim teaches a biopotential signal acquisition system comprising an ADC configured to provide a digital version of the analogue measured signal ([Abstract]). Kim further teaches that the ADC is a Sigma-Delta ADC ([0028]). Utilizing a Sigma-Delta ADC increases the analogue to digital signal resolution of the acquisition system ([0028]). Increasing signal resolution is an obvious benefit to the Tarler/Chi/Varadan/Nielsen combination. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a Sigma-Delta ADC rather than a generic ADC in order to increase the signal resolution of the device.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over the Tarler/Chi/Varadan combination as applied to claim 1 and described above, in view of Jung et al. (hereinafter ‘Jung’, US 20130127708 A1).
Regarding claim 8, the Tarler/Chi/Varadan combination discloses the wireless EEG recording system of claim 1, wherein each two-channel electrode is positioned on the body (Tarler [Col 15, lines 27-55]: the electrode patch has weak points 22 built in to facilitate separation from each other and the base as seen in Fig. 1 – this means they can be placed wherever desired)
However, the Tarler/Chi/Varadan combination is silent to the electrodes being positioned less than 2 cm from each other.
Jung teaches a system for detecting and processing EEG signals ([Abstract]). In order to measure the EEG, the electrodes are placed 2cm in a headband which the user wears ([0059]). While Jung teaches a headband and the Tarler/Chi/Varadan teaches a patch, the distance between electrodes is simply the desired distance between the electrodes for optimal EEG signal detection which is desirable no matter the attachment means. It would have been an obvious matter of design choice to one having ordinary skill in the art at the time the invention was made to place the electrodes 2cm apart or less, since applicant has not disclosed that this placement is critical to the measurement of EEG signals. Furthermore, Tarler is capable of placing the electrodes well within 2 cm of each other since they are initially connected and can be separated for any desired placement, such as at 2 cm apart as taught by Jung.
Claim(s) 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over the Tarler/Chi/Varadan combination as applied to claim 1 and described above, in view of Cadell et al. (hereinafter ‘Cadell’, US 20020067269 A1).
Regarding claim 9, the Tarler/Chi/Varadan combination discloses the wireless EEG recording system of claim 1, wherein the RF transmitter transmits the packet to the external receiver ([Col 14, lines 28-62]: the remote communication station of the various embodiments of the invention can be any device known to receive RF transmissions used by those skilled in the art to receive transmissions of physiological data from the electrode patch; [Col 13, lines 25-67]: the transmission channel can be changed for interference free transmission)
However, the Tarler/Chi/Varadan combination is silent to the system using an industrial, scientific, and medical (ISM) band.
Cadell teaches an apparatus and system for power efficient, flexible, and data efficient wireless transmission of measured physiological parameters such as EEG ([Abstract]). This is the same goal of the processing and transmission means of the Tarler/Chi/Varadan combination. In the preferred embodiment of the invention, Cadell teaches that the transmitter utilizes ISM bands, namely the 902-928 MHz band, the 2.4-2.5 GHz, or the 5.725-5.785 GHz, in the transmission of data which allows for unlicensed operation in most countries ([0016]). Furthermore, the transmitter allows for providing multiple frequencies of transmission within the 902 to 928 MHz band of frequencies for the simultaneous transmission of an increased number of signals ([0012]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize the ISM bands of transmission since they allow for unlicensed operation and the 902 to 928 MHz band can allow for the transmission of multiple frequencies simultaneously.
Regarding claim 10, the Tarler/Chi/Varadan/Cadell combination discloses the wireless EEG recording system of claim 9, wherein the transmitter operates in a range of 902 MHz to 928 MHz (Cadell [0012]: transmission within the 902 to 928 MHz band) .
Regarding claim 11, the Tarler/Chi/Varadan/Cadell discloses the wireless EEG recording system of claim 9 as described above.
Cadell further states the transmitter device has the ability to provide as many as 32 channels in groupings of 8, 16, 24, or 32 or individual 1 through 8 channels, i.e., any combination of between 1 and 32 (with the possibility of as many as 64) channels can be sampled, put in packet format, and transmitted ([0034]). The transmitter device provides a more data efficient telemetry system by providing a greater data transmission rate in a smaller bandwidth ([0011]). The present invention also provides a method of providing multiple frequencies of transmission within the 902 to 928 MHZ band of frequencies for the simultaneous transmission of an increased number of signals ([0012]). 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 transmitter of Tarler such that it can support between 1 and 32 channels (which includes the claimed 12, thus the device can support twelve devices) to allow for the simultaneous transmission of an increased number of signals across the transmission band.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over the Tarler/Chi/Varadan combination as applied to claim 1 and described above, in view of Calhoun et al. (hereinafter ‘Calhoun’, US 20150035378 A1).
Regarding claim 12, the Tarler/Chi/Varadan combination discloses the wireless EEG recording system of claim 1 as described above.
However, the Tarler/Chi/Varadan combination is silent to the RF transmitter transmitting the packet to the external receiver using less than or equal to 200 Kbps.
Calhoun teaches an integrated circuit such as that included as a portion of a sensor node ([Abstract]). The analog input to the system can include an input indicative of a physiological signal such as an EEG ([0041]). Thus, the circuitry of Calhoun is analogous to Tarler, Varadan, and the instant application as it is directed towards optimizing EEG signal processing. Calhoun further teaches that the device can include a transmitter circuit which is configured for sub-milliwatt operation which avoids a need for one or more large discreet bucket or filtering capacitors ([0061]). The wireless transmitter circuit provides about a 200 kbps transmission rate ([0061[). Capacitors are larger components on the chip and are often located on shared circuit assemblies or modules ([0069]). Thus, transmitting at a data rate of around 200 kbps eliminates the need for these larger capacitors, resulting in a decrease in size which is an obvious benefit to patch EEG devices as it makes them less cumbersome for the wearer. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to ensure the transmitter is configured for sub-milliwatt operation providing a 200 kbps transmission rate in order to eliminate the need for large capacitors on the device.
Response to Arguments
Applicant’s arguments, see page 5, filed 6/4/2026, with respect to the 112b rejections of claims 1-13 have been fully considered and are persuasive in light of the amendments. The 112b rejections of claims 1-13 have been withdrawn.
Applicant’s arguments with respect to claim 1 regarding Tarler not teaching or disclosing collecting EEG data including two spatially orthogonal EEG signals 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. Specifically, Chi is now used to teach this limitation.
Applicant's arguments regarding Tarler not teaching two electrodes spaced orthogonally with respect to a common electrode have been fully considered but they are not persuasive. As described above, the electrodes of Tarler can be moved due to the flexible arms 17 in Fig. 2. This allows for the electrodes to be placed orthogonally relative to the reference electrode 15. Because there is versatility in electrode placement, they can be placed in whatever location is desired by the user. Therefore, that argument is not persuasive.
Currently, “configured to detect EEG data including two spatially orthogonal EEG signals” is recited functionally in the claim. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the claim, then it meets the claim. The examiner recommends incorporating the input circuitry structure that provides for the claimed function as a potential way to overcome the prior art of record.
Therefore, the rejection of claim 1 remains. Subsequently, the rejections of claims 2-13 remain.
Conclusion
THIS ACTION IS MADE FINAL. 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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/W.M./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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