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 .
Election/Restrictions
Applicant’s election with traverse of Species A directed to the embodiment disclosed in Fig. 3 in the reply filed on June 1, 2026 is acknowledged. The traversal is on the ground(s) that according to the applicant, species A,B,C and D are not patentably distinct from one another because they share a common EEG device and differ only by additional retention features built upon a common structural foundation. This is not found persuasive because the embodiments are directed to materially different electrical grounding configurations in addition to different supporting structure as followings:
1) Species A directed to the embodiment disclosed in Fig. 3:
Hand-held device-mounted grounding electrode configuration
2) Species B directed to the embodiment disclosed in Fig. 5:
Head band-supported forehead grounding configuration
3) Species C directed to the embodiment disclosed in Fig. 6:
Chin band-supported grounding configuration
4) Species D directed to the embodiment disclosed in Fig. 8:
Hand-grip-conductive plate electrode configuration
Because each species employs a materially different structural and electrical grounding configuration, examination would require separate searches directed to different grounding electrode locations, conductive support structures, electrical connection arrangements, and associated prior-art teachings. Accordingly, examining all species together would impose a serious search and examination burden. The requirement is still deemed proper and is therefore made FINAL.
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, 5-7, 24-25, 29, 31 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over “Chiang” (US20150080698A1) in view of “Wijayaratna” (US20170055911A1)
Regarding claim 1,
Chaing teaches A device for measuring electroencephalography (EEG) recordings of a subject (Paragraph, 0007: “provide a measurement device having both electroencephalography (EEG) and electrocardiography (ECG) functionalities, which is capable of receiving EEG signals”), comprising:
a casing (shell) (Paragraph, 0008: “a measurement device with EEG and ECG functionalities. The measurement device comprises a shell”);
at least two first electrodes extending from a first surface of the casing (Paragraph, 0008: “The shell comprises a first contact and a second contact located at a first side of the shell; and a third contact”),
the at least two first electrodes being configured to contact a scalp of the subject during an EEG recording (Paragraph, 0018: “When the measurement device 10 is in an EEG mode, the contacts N1-N3 may be placed on the forehead of a user, in order to perform EEG measurement”, “The contacts N1-N3, located on the shell of the measurement device 10, are utilized for measuring physiological signals of a human body”, : “The sensing electrodes, composed of metal, conductive foam or other electrically conductive materials, may be disposed on the contacts N1-N3. For example, when the measurement device 10 is utilized for EEG measurement”, and “the contacts N1-N3 may be placed on the forehead of a user”); and
at least one second electrode (Paragraph, 0008: “The shell comprises a first contact and a second contact located at a first side of the shell; and a third contact”)
disposed on a second surface of the casing (Paragraph, 0008: “adjusting the third contact to be located at a second side of the shell when the measurement device is in an ECG mode, wherein the second side is substantially opposite to the first side”, Paragraph, 0022: “the plate 202 may be flipped to the second side S2”, and Paragraph, 0024: “the contact N3 is turned to the second side S2”) and
However, Chiang is silent on configured to provide a ground connection during the EEG recording.
Wijayaratna teaches configured to provide a ground connection during the EEG recording (Paragraph, 0045: “The phone may comprise an earth electrode positioned on the rear side of the phone body such that the electrode contacts the palm of the user's hand when the phone is held in use, the earth electrode configured to ground the user prior to measurement of the vital sign by the first and second ECG electrodes.”, and Paragraph, 0199: “The phone 801 also comprises a second ECG electrode 808 c positioned on the earpiece 806 of the phone 801 such that the electrode 808 c contacts the ear of the user during use, and an earth electrode 838 positioned on the rear side 803 of the phone body such that the electrode 838 contacts the palm of the user's hand when the phone 801 is held in use”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chiang with Wijayaratna’s ground connection because establishing ground connection prior to physiological signal measurement would ensure proper electrical contact and improving the reliability of the measured biopotential signals (Paragraph, 0199).
Regarding claim 2, Chiang in view of Wijayaratna teaches the device of claim 1, (See rejection of claim 1 above),
Chaing teaches wherein the at least two first electrodes (Paragraph, 0008: “The shell comprises a first contact and a second contact located at a first side of the shell; and a third contact”)
includes at least one sensing electrode (Paragraph, 0020: “two of which may correspond to a pair of differential signals of the single measurement channel (0018) The contacts N1-N3, located on the shell of the measurement device 10, are utilized for measuring physiological signals of a human body”, and Paragraph, 0018: “The sensing electrodes, composed of metal, conductive foam or other electrically conductive materials, may be disposed on the contacts N1-N3. For example, when the measurement device 10 is utilized for EEG measurement”) and
at least one reference electrode (Paragraph, 0020: “the other may correspond to a reference signal.”).
Regarding claim 3, Chiang in view of Wijayaratna teaches the device of claim 2, (See rejection of claim 2 above),
Chiang teaches wherein the at least one sensing electrode (Paragraph, 0018: “when the measurement device 10 is utilized for EEG measurement, the measurement device 10 is worn on the forehead of the user; hence the conductive foam may be utilized as sensing electrodes on the contacts N1-N3”, and Paragraph, 0020: “two of which may correspond to a pair of differential signals of the single measurement channel”) is
configured to contact the scalp (Paragraph, 0018: “the contacts N1-N3 may be placed on the forehead of a user, in order to perform EEG measurement”)
at a desired location for the EEG recording (Paragraph, 0026: “The purpose of adjusting the contact N3 to be located at the same side or opposite side with the contacts N1 and N2 is to allow the user to conveniently measure the physiological signals in both the EEG mode and the ECG mode”, “the position of the contacts N1-N3 may be adjusted ergonomically. For example, when the measurement device 10 is worn on the user's forehead for EEG measurement, the contacts N1-N3 may not be disposed at the same flat surface, and may be adjusted according to the radian or the shape of the forehead”).
Regarding claim 5, Chiang in view of Wijayaratna teaches the device of claim 1, (See rejection of claim 1 above),
Chiang teaches wherein the second surface of the casing (Paragraph, 0008: “adjusting the third contact to be located at a second side of the shell”, “a measurement device with EEG and ECG functionalities. The measurement device comprises a shell”, and “The shell comprises a first contact and a second contact located at a first side of the shell”)
is opposite the first surface of the casing (Paragraph, 0008: “the second side is substantially opposite to the first side”, Paragraph, 0022 “the plate 202 may be flipped to the first side S1”, “the plate 202 may be flipped to the second side S2,”, and Paragraph, 0024: “the contact N3 and the contacts N1 and N2 are located at opposite sides on the shell of the measurement device 20”).
Regarding claim 6, Chiang in view of Wijayaratna teaches the device of claim 1, (See rejection of claim 1 above),
Chiang teaches wherein the at least one second electrode (Paragraph, 0008: “The shell comprises a first contact and a second contact located at a first side of the shell; and a third contact”, and Paragraph, 0022: “the contact N3 is located at the plate 202”) is
configured to contact a hand of the subject (Paragraph, 0018: “the user may hold the measurement device 10 in their hand, e.g. by placing the right index finger, the left index finger and the left thumb on the contacts N1-N3, respectively”, and Paragraph, 0024: “enabling the user to hold the measurement device 20 by placing both index fingers on the contacts N1 and N2 respectively and placing the left thumb on the contact N3 to perform ECG measurement”)
while the subject is holding the device (Paragraph, 0022: “the user may hold the measurement device 70 in their hand for ECG measurement”, and Paragraph, 0027: “This enables the user to hold the measurement device 50 in their hand for ECG measurement”.
Regarding claim 7, Chiang in view of Wijayaratna teaches the device of claim 6, (See rejection of claim 6 above),
Chiang teaches further comprising a strap (belt 502) (Paragraph, 0027: “As shown in FIG. 5A and FIG. 5B,the measurement device 50 includes a belt 502 FIG.5A-5B shows belt 502 attached to the device”)
connected across the second surface of the casing (Paragraph, 0027: “A terminal of the belt 502 is connected to the shell of the measurement device 50”, “The button wraps 506 and 508, respectively located at the first side S1 and the second side S2 of the shell of the measurement device 50”, and “the belt 502 may be turned to the second side S2 Figures 5A-5B showing one end fixed to the shell and opposite end fixed on the second side”),
wherein the strap allows the hand of the subject to hold the device (Paragraph, 0027: “This enables the user to hold the measurement device 50 in their hand for ECG measurement”, and Paragraph, 0024: “the contact N3 and the contacts N1 and N2 are located at opposite sides on the shell of the measurement device 20, enabling the user to hold the measurement device 20”)
while contacting the at least one second electrode (Paragraph, 0024: “by placing both index fingers on the contacts N1 and N2 respectively and placing the left thumb on the contact N3 to perform ECG measurement”, and paragraph, 0028: “the contact N3 may also be realized by the button 504”).
Regarding claim 24, Chiang in view of Wijayaratna teaches the device of claim 1, (See rejection of claim 1 above),
Chiang teaches further comprising at least one processor (Paragraph, 0019: “The processor 102 is utilized for performing signal processing. The EEG signal processing circuit 104, coupled to the processor 102, is utilized for amplifying and filtering the signals received in the EEG mode”).
Regarding claim 25, Chiang in view of Wijayaratna teaches the device of claim 24, (See rejection of claim 24 above),
Chiang teaches wherein the at least one processor is configured to send data (Paragraph, 0019: “The signal transmission module 110, coupled to the processor 102, is utilized for transmitting signals to an external electronic device after the signals are interpreted by the processor 102”)
associated with the EEG recording to at least one external device (Paragraph, 0019: “The signal transmission module 110, coupled to the processor 102, is utilized for transmitting signals to an external electronic device after the signals are interpreted by the processor 102”).
Regarding claim 29, Chiang in view of Wijayaratna teaches the device of claim 1, (See rejection of claim 1 above),
Chiang teaches wherein the at least one second electrode comprises a flat conductive plate (Paragraph, 0008: “The shell comprises a first contact and a second contact located at a first side of the shell; and a third contact”, Paragraph, 0018: “The sensing electrodes, composed of metal, conductive foam or other electrically conductive materials, may be disposed on the contacts N1-N3”, and Paragraph, 0022: “The plate 202, which is connected with the shell of the measurement device 20 via the pivot 204, may be flipped between the first side S1 and the second side S2 of the shell.
Figure 2B,4B, and 5A-5A illustrates flat member”)
disposed on the second surface of the casing (Paragraph, 0008: “adjusting the third contact to be located at a second side of the shell”, and Paragraph, 0024: “the contact N3 is turned to the second side S2 with the plate”).
Regarding claim 31, Chiang in view of Wijayaratna teaches the device of claim 25, (See rejection of claim 25 above),
Chiang teaches wherein the at least one processor is configured to wirelessly transmit data associated with the EEG recording to the at least one external device via a wireless communications module (Paragraph, 0019: “The signal transmission module 110, coupled to the processor 102, is utilized for transmitting signals to an external electronic device after the signals are interpreted by the processor 102”, “The signal transmission module 110 may use various wireless communication technologies such as Bluetooth or Wireless Fidelity (Wi-Fi) to transmit signals. The external electronic device may be any device with signal transmission functionality such as a laptop, tablet or smart phone”).
Regarding claim 34, Chiang in view of Wijayaratna teaches the device of claim 29, (See rejection of claim 29 above),
Chiang teaches wherein the at least one second electrode further (Paragraph, 0008: “The shell comprises a first contact and a second contact located at a first side of the shell; and a third contact”)
comprises an additional flat conductive plate disposed on a side surface of the casing (the contact, N3 on the surface of the plate 202, as shown in FIG. 2A) (Paragraph, 0018: “The sensing electrodes, composed of metal, conductive foam or other electrically conductive materials, may be disposed on the contacts N1-N3”, and Paragraph, 0022: “The plate 202, which is connected with the shell of the measurement device 20 via the pivot 204, may be flipped between the first side S1 and the second side S2 of the shell. Figure 2B,4B, and 5A-5A illustrates flat member”).
Claims 4 is rejected under 35 U.S.C. 103 as being unpatentable over Chiang in view of Wijayaratna and further “Beche” (EP 3427658 A1)
Claims 4 is rejected under 35 U.S.C. 103 as being unpatentable over Chiang in view of Wijayaratna and further “Beche” (EP 3427658 A1)
Regarding claim 4, Chiang in view of Wijayaratna teaches the device of claim 2, (See rejection of claim 2 above),
Chiang teaches wherein the at least one reference electrode (Paragraph, 0020: “the other may correspond to a reference signal”) is
configured to contact the scalp (Paragraph, 0018: “The contacts N1-N3, located on the shell of the measurement device 10, are utilized for measuring physiological signals of a human body”, “The contacts N1-N3 are all located at the same side on the shell of the measurement device 20, enabling the user to wear the measurement device 20 on their forehead to perform EEG measurement”)
However, Chiang is silent on at a location of low electrical activity.
Beche teaches at a location of low electrical activity (Paragraph, 0003: “In the case of an EEG (electroencephalography) type measurement, the electrodes are placed on the patient's head to measure the electrical activity of the brain. The signals taken are then very weak and require amplification”, Paragraph, 0004: “In a unipolar arrangement, the reference electrode is positioned in a location of low electrical activity”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chiang with Beche’s reference electrode connection at a location of low electrical activity because connecting reference electrode is at a location of low electrical activity would have provided a stable reference for measuring the small EEG potential difference, thereby improving EEG signal detection (Beche, Paragraph, 0004-0007).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Chiang in view of Wijayaratna and further “Levendowski” (US6381481B1)
Regarding claim 19, Chiang in view of Wijayaratna teaches the device of claim 1, (See rejection of claim 1 above),
Chiang does not teach further comprising at least one audio speaker configured to provide audio feedback to the subject.
Levendowski teaches further comprising at least one audio speaker (Col. 13, lines 9-14: “The DPU can thus acquire EEG signals from the EEG electrode locator headgear, run the EEG data analysis algorithms, and use the digital to analog converter and Speaker to generate audio feedback alert messages to the user”, Col. 13, lines 20-24: “when the DPU determines that an audio alert message or Verbal message should be transmitted to the user, a signal is transmitted from the DPU to the EEG electrode locator headgear to present a specific message”, Col. 13, lines 24-31: “Audio messages can be Stored in analog format in flash memory in the EEG electrode locator headgear where the analog to digital converter, power Supply and processor are mounted. The analog message can then be presented to the user either through one or more speaker mounted on the EEG electrode locator headgear, or through an earphone that attaches to a connector incorporated into the EEG electrode locator headgear”)
configured to provide audio feedback to the subject (Col. 13, lines 9-14: “The DPU can thus acquire EEG signals from the EEG electrode locator headgear, run the EEG data analysis algorithms, and use the digital to analog converter and Speaker to generate audio feedback alert messages to the user”,
Col. 13, lines 20-24: “when the DPU determines that an audio alert message or Verbal message should be transmitted to the user, a signal is transmitted from the DPU to the EEG electrode locator headgear to present a specific message”, and Col. 13, lines 24-31: “Audio messages can be Stored in analog format in flash memory in the EEG electrode locator headgear where the analog to digital converter, power Supply and processor are mounted. The analog message can then be presented to the user either through one or more speaker mounted on the EEG electrode locator headgear, or through an earphone that attaches to a connector incorporated into the EEG electrode locator headgear”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chiang with Levendowski’s audio speaker because using an audio speaker to provide audio alert or verbal messages to the subject would have facilitated communication of information from the EEG monitoring system to the subject, thereby improving user notification and operation of EEG monitoring system without requiring the subject to continuously monitor a visual display (Levendowski, Col. 13, lines 13-19).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Chiang in view of Wijayaratna, Levendowski, and “Meggiolaro” (US20120059273A1)
Regarding claim 20, Chiang in view of Wijayaratna and Levendowski teaches the device of claim 19, (See rejection of claim 19 above),
Chiang does not teach wherein the audio feedback provides an indication that the EEG recording has started and/or an indication that the EEG recording has ended.
Levendowski teaches wherein the audio feedback (Col. 13, lines 9-14: “The DPU can thus acquire EEG signals from the EEG electrode locator headgear, run the EEG data analysis algorithms, and use the digital to analog converter and Speaker to generate audio feedback alert messages to the user”, Col. 13, lines 20-24: “when the DPU determines that an audio alert message or Verbal message should be transmitted to the user, a signal is transmitted from the DPU to the EEG electrode locator headgear to present a specific message”, Col. 13, lines 24-31: “Audio messages can be Stored in analog format in flash memory in the EEG electrode locator headgear where the analog to digital converter, power Supply and processor are mounted. The analog message can then be presented to the user either through one or more speaker mounted on the EEG electrode locator headgear, or through an earphone that attaches to a connector incorporated into the EEG electrode locator headgear”),
Meggiolaro teaches provides an indication that the EEG recording has started and/or an indication that the EEG recording has ended (Paragraph, 0119: “)The system calibration is performed in two steps. In the first step, the user needs to carry out mental activities asked by the software, to calibrate it. First, the user is asked to trial (without any body movement) an imaginary movement of his/her feet for eleven seconds (a short beep starts the count and a long beep indicates the end of the acquisition), from which only the last ten seconds are recorded. Then, after a five second pause, the next mental activity (in this case the imaginary movement of his/her tongue) is recorded in the same way, and so on for the left and right arm activities.”, and Paragraph, 0120: “Note that the five second pauses between recordings are important for the user to relax and get ready for the next step. Also, discarding the first second of each recording is important for an efficient calibration, to guarantee no auditory artifacts are present due to the short beep that signals the start of each count”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chiang with Meggiolaro’s audio feedback indication because using an audio feedback indication such as short/long beep sound to the subject would have enabled the user to the subject to prepare for each recording interval and facilitated efficient calibration by coordinating EEG acquisition with the subject’s mental task (Meggiolaro, Paragraph, 0119-0120).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Chiang in view of Wijayaratna, Levendowski and “Riehl” (US 20050234286 A1)
Regarding claim 21, Chiang in view of Wijayaratna and Levendowski teaches the device of claim 19, (See rejection of claim 19 above),
Chiang does not teach wherein the audio feedback provides an indication of the device’s location relative to a desired location on the scalp of the subject.
Riehl teaches wherein the audio feedback provides an indication of the device’s location relative to a desired location on the scalp of the subject (Paragraph, 0006: “The indication is preferably provided to a display device that indicates to an operator of the TMS device whether the TMS coil assembly is properly positioned at the position and/or in which direction to move the TMS coil assembly to the position in the event that the TMS coil assembly is not at the position. The indication also may be provided to a sound generator that generates a sound that is detected to indicate to an operator of the TMS device whether the TMS coil assembly is properly positioned at the position”, Paragraph, 0016: “the sensors may comprise a loop of conducting material placed at the treatment position (e.g., affixed to the patient's scalp). When the TMS coil assembly is in proximity to the loop of conducting material, a voltage is induced therein when pulses are applied to the TMS coil assembly.”, Paragraph, 0017: “FIG. 17 illustrates an embodiment in which EEG-type leads and electrodes, or their equivalents, may be used to sense currents induced in the scalp by the TMS magnetic pulse”, Paragraph, 0051: “where FIG. 3A indicates poor contact with the patient's scalp and FIG. 3B indicates good contact with the patient's scalp. As illustrated, this display may be useful in guiding the operator to reposition the TMS coil assembly 20 to improve scalp contact. Audible feedback to the operator also may be provided”, and Paragraph, 0072: “EEG-type leads and electrodes 540, or their equivalents, may be used to sense currents induced in the scalp by the TMS magnetic pulse. If the TMS coil assembly 20 is moved away from the scalp, these currents will shift and diminish in amplitude. This change is detected by processing the signals from the EEG-type leads 540 in suitable signal processing electronics. A minimum of two EEG-type leads is required. Those skilled in the art will appreciate that careful placement of the EEG-type electrodes 54”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chiang with Riehl’s audible feedback indication of device’s location because audible positioning feedback would have enabled the operator to determine whether the device is properly positioned and provided guidance for repositioning the device to achieve proper contact on scalp of the patient’s head, and predictably improved device placement during use (Riehl, Paragraph, 0006,0051-0054, 0073).
Claims 22 -23 are rejected under 35 U.S.C. 103 as being unpatentable over Chiang in view of Wijayaratna, and “Kidmose”(US 20120238856 A1)
Regarding claim 22, Chiang in view of Wijayaratna teaches the device of claim 1, (See rejection of claim 1 above),
Chiang does not teach further comprising at least one battery.
Kidmose teaches further comprising at least one battery (Paragraph, 0022: “the portable monitoring device is prepared for comprising a battery for providing power to the hearing aid and the EEG monitoring system, where the power to the measuring unit is transferred wirelessly. This makes it possible to have an implant powered from an external unit, whereby a surgical operation to change battery in an implanted measuring unit can be avoided”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chiang with Kidmose’s battery because integrating the battery into a simple portable monitoring device would have reduced size and manufacturing cost while allowing shared use of device components, thereby improving portability (Kidmose, Paragraph, 0016, 0022).
Regarding claim 23, Chiang in view of Wijayaratna, and Kidmose teaches the device of claim 22, (See rejection of claim 22 above),
Chiang does not teach wherein the at least one battery is rechargeable.
Kidmose teaches wherein the at least one battery is rechargeable (Paragraph, 0053: “The implant unit 3 also comprises power supply means for the electronic module. This may be in the form of a battery which can be recharged by external means, e.g. through induction, or which is recharged from a system”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chiang with Kidmose’s rechargeable battery because integrating the rechargeable battery into a simple portable monitoring device would have reduced size and manufacturing cost while allowing shared use of device components, thereby improving portability, furthermore, externally rechargeable power allows the device to be recharged without replacing the battery and improving the practicality of long-term portable EEG monitoring (Kidmose, Paragraph, 0016, 0022, 0053).
Claims 26 is rejected under 35 U.S.C. 103 as being unpatentable over Chiang in view of Wijayaratna, and “Mercier” (US 20200170568 A1),
Regarding claim 26, Chiang in view of Wijayaratna teaches the device of claim 25, (See rejection of claim 25 above),
Chiang does not teach wherein the at least one processor is configured to determine at least one EEG characteristic of the subject based on the EEG recording.
Mercier teaches wherein the at least one processor (Paragraph, 0016: “a processing module comprising a selection module”, and Paragraph, 0038: “the system 1 comprises a module for acquisition 3 of at least one measured signal, a processing module 5 and a module for playing 4 a signal from an acoustic stimulation sequence signal”) is
configured to determine at least one EEG characteristic of the subject based on the EEG recording (Paragraph, 0097: “The falling-asleep metric determination module can extract representative brain wave patterns from the measured signal”, Paragraph, 0098: “An alternative method for determination of the falling-asleep estimator from EEG signals considers one and/or another of the beta, alpha or theta waves of the user”, and Paragraph, 0105: “we want to identify a pattern over time comprising a decrease in beta waves (12-40 Hz), followed by an increase of alpha waves (8-12 Hz), then an increase of theta waves (4-8 Hz). Such a pattern can be seen to give a high score for the falling asleep indicator”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chiang with Mercier because determining EEG characteristics, including spectral content and alpha-, beta-, and theta-wave patterns based on the EEG recording, would have enabled characterization of the user’s physiological state, thereby improving interpretation of the recorded EEG signals and facilitating adaptive operation of the EEG monitoring system (Mercier, Paragraph, 0098, 0103, 0105).
Claims 27 is rejected under 35 U.S.C. 103 as being unpatentable over Chiang in view of Wijayaratna, and “Van Den Ende” (US 20190000338 A1),
Regarding claim 27, Chiang in view of Wijayaratna teaches the device of claim 1, (See rejection of claim 1 above),
Chiang does not teach wherein the at least two first electrodes are dry electrodes comprising short pins configured to penetrate a hair volume and contact the scalp of the subject.
Van Den Ende teaches wherein the at least two first electrodes are dry electrodes (FIG. 1 shows a fully dry EEG electrode headset. For instance, Imec NL (Holst) has developed a headset using dry EEG electrodes. Commercially available dry headsets are provided by Cognionics. Dry electrodes have partially overcome some of the above-discussed problems by applying a pin-like structure that has the ability to bypass the hairs on the scalp.)
configured to penetrate a hair volume and contact the scalp of the subject (The dry electrodes hardly achieve the signal quality and good electrical connection (low impedance) which can be achieved with the wet or hydrogel electrodes. These dry EEG electrodes are still very sensitive to making good contact. This must be corrected by hand (i.e., by a trained supervisor in clinical environment) and will amount in extra setting up time. In a less controlled environment, the incorrect placement can also lead to loss of data.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chiang with Van Den Ende’s dry EEG electrode because incorporating pin-like electrode would have improved the contact quality between the dry electrode and the user’s scalp, thereby facilitating acquisition of sufficient-quality EEG signals. (Van Den Ende, Paragraph, 0009,0035,0062).
Claims 28 is rejected under 35 U.S.C. 103 as being unpatentable over Chiang in view of Wijayaratna, and “Attal” (US 20160157777 A1),
Regarding claim 28, Chiang in view of Wijayaratna teaches the device of claim 1, (See rejection of claim 1 above),
Chiang does not teach wherein the at least one second electrode is configured to provide common mode rejection to reduce interference from power line noise during the EEG recording.
Attal teaches wherein the at least one second electrode (Paragraph, 0047: ““Ground electrode” or “bias electrode” refers to an electrode configured to serve as a common reference point for all voltage in the system. In one embodiment, the ground electrode can bias the subject's body to a known reference potential used for the built-in drive amplifier in the hub”) is
configured to provide common mode rejection to reduce interference from power line noise during the EEG recording (Paragraph, 0047: “Ground electrode” or “bias electrode” refers to an electrode configured to serve as a common reference point for all voltage in the system. In one embodiment, the ground electrode can bias the subject's body to a known reference potential used for the built-in drive amplifier in the hub.”, Paragraph, 0081: “the headset of the invention also includes a ground electrode which isolates a human subject from the ground of the power supply. This configuration comprising a ground, a reference and an acquisition electrode is designed to reject the spatially constant common-mode potential and amplify the difference in potential between pairs of skin locations”, and Paragraph, 0083: “the headset is configured such that the ground electrode is placed on the forehead of the subject. In some embodiment, reference electrode is located at any location on a subject head. According to one embodiment, the headset is configured such that the ground electrode is placed on ear location of the subject”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chiang with Attal because incorporating a second electrode configured to provide common mode rejection would have improved and optimized noise reduction in the amplifier by serving as a common reference point for all voltages in the system, thereby providing better separation of bio-signal from interference signals and noise (Attal, Paragraph, 0086, and 0090).
Claims 30, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Chiang in view of Wijayaratna, and “Hayakawa” (US 20120190959 A1),
Regarding claim 30, Chiang in view of Wijayaratna teaches the device of claim 1, (See rejection of claim 1 above),
Chiang does not teach further comprising an EEG amplifier disposed within the casing, wherein the at least two first electrodes and the at least one second electrode are electrically connected to the EEG amplifier.
Hayakawa teaches further comprising an EEG amplifier (Paragraph, 0091: “This measurement section 30 includes an amplification section 31”, and Paragraph, 0093: “The amplification section 31 has a differential amplifier 31A. The differential amplifier 31A amplifies the potential difference between the reference electrode 12 and the probe electrode 13 as a signal (hereinafter, this will be also referred to as bio-waveform signal), and outputs the amplified biosignal to the filter section 32”)
disposed within the casing (Paragraph, 0090: “FIG. 4 shows the configuration of a measurement section that measures a biosignal sensed by each of the reference electrode 12 and the probe electrode 13. A circuit board and the like in the measurement section are provided in the surface or in the inside of the hair band 2, for example”, Paragraph, 0091: “This measurement section 30 includes an amplification section 31, a filter section 32, an A(Analog)/D(Digital) conversion section 33, an analysis section 34, a memory 35, and a communication section 36”, and Paragraph, 0161: “The outer surface of the hair band 310 is provided with a casing (hereinafter, this will be also referred to as protruding casing) 360 in the form of a protrusion that accommodates electronic equipment (see FIG. 9 to FIG. 16). The protruding casing 360 includes a fixed region 361 and a protruding region 362 (see FIG. 9 to FIG. 12, FIG. 14, and FIG. 16). The fixed region 361 is fixed to the outer surface of the hair band 310 situated directly above the forehead abutment section 350”),
wherein the at least two first electrodes and the at least one second electrode are electrically connected to the EEG amplifier (Paragraph, 0093: “The amplification section 31 has a differential amplifier 31A. The differential amplifier 31A amplifies the potential difference between the reference electrode 12 and the probe electrode 13 as a signal (hereinafter, this will be also referred to as bio-waveform signal), and outputs the amplified biosignal to the filter section 32. Since the probe electrode 13 is an electrode placed at the vertex position”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chiang with Hayakawa because amplifying the potential difference between the reference electrode and the probe electrode would have facilitated subsequent signal processing by providing an amplified bio-signals for filtering, analogue-to-digital conversion, and signal analysis, thereby improving measurement sensitivity of the bio signal (Hayakawa, Paragraph, 0090-0094).
Regarding claim 33, Chiang in view of Wijayaratna teaches the device of claim 24, (See rejection of claim 24 above),
Chiang does not teach wherein the at least one processor is configured to assign a sensing function or a reference function to each of the at least two first electrodes.
Hayakawa teaches wherein the at least one processor (Paragraph, 0099: “The analysis section 34 includes a CPU, a ROM, a RAM serving as the work memory for the CPU, a speaker, and a clock (clocking section). In this ROM, a program for causing an analysis process to be executed”) is
configured to assign a sensing function or a reference function to each of the at least two first electrodes (Paragraph, 0322: “each of the supports 120.sub.i can be also used as a probe electrode. In the biosignal measurement pillow 100, as shown in FIG. 50, x rows.times.y columns of supports are assigned as probe channels PCH.sub.j (j=2, 3, . . . , or n (n is an integer))”, Paragraph, 0329: “the analysis section 134 detects the probe channels PCH.sub.j to be selected”, Paragraph, 0323: “Each of the supports constituting the probe channels PCH.sub.j is connected to one input terminal of the corresponding amplifier 130.sub.j”, “a reference electrode 131 is connected to the other input terminal of the amplifier 130.sub.j”, Paragraph, 0327: “By using these biosignals, the analysis section 134 is configured to execute the same processing as the processing described above for the analysis section 34, and also execute an electrode (probe channel) selection process in accordance with the flowchart shown in FIG. 53, for example.”, and Paragraph, 0145: “Probe electrodes 320A and 320B are provided in the recesses 311 and 312”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chiang with Hayakawa because assigning distinct sensing and reference functions to respective electrodes would have enabled amplification of the potential difference between the reference electrode and the probe electrode, thereby facilitating subsequent filtering, A/D conversion, and signal analysis for reliable biosignal processing (Hayakawa, Paragraph, 0091, and 0094).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Chiang in view of Wijayaratna, and “O'Neill” ((US7231723B1)
Regarding claim 32, Chiang in view of Wijayaratna teaches the device of claim 1, (See rejection of claim 1 above),
Chaing does not teach further comprising at least one positional sensor configured to provide an indication of a location of the device relative to a desired brain region of the subject.
O'Neill teaches further comprising at least one positional sensor (Col.5, lines 31-36: “the adjusted position of the sidebar frame members 108 may be automatically determined by a position sensor 114 or a similar device to detect the relative positions of the first and second portions 202 and 204 of each sidebar frame member 35 200 (FIG. 2)”, and Col.1, lines 21-27: “neural sensors, such as electroencephalogram (EEG), functional near infrared (fNIR) sensors and the like, are placed on the Surface of a human Subjects head. These sensors typically need to be positioned accurately and repeatably with respect to some standard coordinate system. A standard known as the 10-20 coordinate system has been established for neural research”)
configured to provide an indication of a location of the device (Col.2, lines 10-17: “taking reference
system measurements or other purposes. The system may also include a computing device to perform at least one of a group including converting measurements from the adjust able frame to coordinates of a predetermined reference system and converting coordinates of the predetermined reference system to position adjustments on the adjustable frame”)
relative to a desired brain region of the subject (Col.1, lines 31-33: “any sensor location device must also be able to adjust to individual subjects. A 10-20 grid can be laid out by measuring and marking a subjects head by hand”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chiang with O'Neill’s indication of device’s location because indicating the device’s location relative to a desired location on the scalp of the subject would have simplified locating the desired scalp location and recording the desired scalp location relative to the 10-20 reference grid, thereby enabling quick and accurate replication of the device location in subsequent sessions (O'Neill, Column 1, lines 20-38, and Column 2, lines 8-18, Column 11, lines 9-30)
Conclusion
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/MORGAN SANGJO SHIM/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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