DETAILED ACTION
This action is pursuant to the claims filed on June 5, 2026. Claims 1-20 are pending. A first action on the merits of claims 1-20 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 . 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 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “wherein the sensor pad comprises a polymer substrate coated with a thin film on a user-facing surface of the sensor pad”. However, there is no support in the specification for said limitation in that the thin film is a user-facing surface.
Paragraph [0036] of the disclosure is cited below:
[0036] In some variations, an interface between an electrical contact 156 and sensor pad 153 can be additionally or alternatively enhanced by coating, painting or electroplating the electrical contact 156 with and/or constructing the sensor pad 153 with, a non-polarizable contact material (e.g., Ag/AgCl) that provides coupling to an electrolyte fluid exuded by the sensor pad 153. Additionally or alternatively, providing non-polarizable contact by way of more of more of the electrical contact 156 and/or the sensor pad 153 can be implemented using any other suitable contact enhancement(s) (e.g., gold plating to minimize corrosion, unplated materials).
Based upon the original specification, there are three possible arrangements. First, coating a non-polarizable contact material which reads on the thin film is disposed between the electrical contact (156) and the sensor pad (153). In this case, the sensor pad is the user-facing surface and not the coated, painted or electroplated non-polarizable contact material. Secondly, the sensor pad (153) is formed with a non-polarizable contact material (Ag/AgCl) which is coupled to an electrolyte fluid. In this case, the electrolyte fluid is the user facing surface not necessarily a thin film. Lastly, the sensor pad (153) is enhanced via gold plating. In this case, since the sensor pad is made from Ag/AgCl, this material cannot be considered a polymer substrate as it is a metal and therefore, even if the gold coating reads on the claimed thin film, it is not coating a polymer substrate. In all three cases, there is no support for said limitation.
Paragraph [0022] of the disclosure discloses:
[0022] The sensors preferably include sensor pads 119 characterized as “dry sensors” or “semi-dry sensors” that either comprise no fluid, or comprise a non-volatile fluid (e.g., are saturated with a non-volatile fluid), such that the dry sensors require little maintenance with regard to maintaining a “wet” state. In variations comprising dry/semi-dry sensors, non-polarizable contact is preferable to reduce or eliminate variability in signal detection and/or reception. Signal detection and/or reception are dependent upon an impedance of an interface of contact between the sensor and the user (e.g., the impedance of a sensor-user interface), which can vary over several orders of magnitude with dry/semi-dry sensors. The dry sensor pad 119 material preferably facilitates generation of a continuous (e.g., unbroken) interface between the sensor and the user. As such, the dry sensor pad material preferably evolves a volume of fluid (e.g., a thin film of fluid at a sensor-user interface), and can additionally or alternatively stimulates perspiration by the user at the sensor-user interface and/or attracts environmental moisture, in order to provide a continuous sensor-user interface. In variations wherein the dry sensor pad 119 material evolves a volume of fluid, the fluid is preferably non-volatile, and the dry sensor pad 119 material preferably is configured to absorb environmental moisture to extend its usable life before maintenance is required. Furthermore, the dry sensor pad 119 material is configured to redistribute fluid (e.g., to depleted regions, to depleted surface layers) passively by internal diffusion; however, the dry sensor pad material can be coupled to a fluid distribution module configured to actively redistribute and/or resupply fluid to depleted sensor regions. In one example, the dry sensor pad 119 comprises a hydrogel polymer (e.g., silicone hydrogel, polyhydroxyethylmethacrylate hydrogel, polymethylmethacrylate hydrogel) saturated with a nonvolatile, electrically conducting electrolyte fluid. In the example, the electrolyte fluid is configured to exude the electrolyte fluid upon application of the sensor to the user and/or upon subjecting the sensor pad 119 material to pressure, in order to provide a continuous sensor-user interface. In other variations, the sensor pads can alternatively comprise “wet sensors” composed of a hydrated material (e.g., hydrogel, porous material) that loses moisture at a rate higher than that of the dry sensors. In variations with wet sensors, the wet sensor material can be configured to absorb fluid prior to sensor placement, after sensor placement, and/or at any other suitable time relative to placement of the sensor(s) on the user's body. In still other variations, the sensor pads can comprise hybrid sensors composed of a composite wet/dry sensor material, or any other suitable sensor material configured to provide sufficient signal detection and transmission. Preferably, the materials used in the set of sensors are 120 are hypoallergenic; however, the set of sensors can additionally or alternatively utilize any other suitable material(s).
According to paragraph [0022], a dry sensor pad material is a hydrogel polymer saturated with nonvolatile, electrically conductive electrolyte fluid. The Examiner notes that saturation is where the fluid penetrates into a specific material, in this case, a hydrogel polymer and may not necessarily form a coating on an exterior surface of the specific material. Therefore, if Applicant intends to recite this particular embodiment, the Applicant should recite “a fluid saturating a polymer substrate” instead of the claim limitation, “coated with a thin film” to differentiate from the embodiment as disclosed in paragraph [0036].
For the purposes of examination, the examiner will apply art based upon the understanding that the hydrogel polymer is the polymer substrate and the thin film is a fluid saturating the polymer substrate.
Accordingly, claims 2-11 are rejected by virtue of its dependency on independent claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5-6, 8-10, 12-15, and 17-20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Do et al. (hereinafter ‘Do’, U.S. PGPub. No. 2009/0105576).
Do et al. (hereinafter ‘Do’, U.S. PGPub. No. 2009/0105576).
In regards to independent claim 1 and claim 5, Do teaches a system (abstract: “apparatus… sensing biopotential signals”; system 300 in Fig. 3), comprising:
a set of sensors (one or more electrodes mounted onto a headset 302 in exemplary schematic diagram of Fig. 3 for 10-20 electrode placement on a subject’s head, [0048], [0052], [0059]-[0060]), wherein each sensor (each of the one or more electrodes are an electrode assembly 700 as shown in Fig. 7A-7B, [0061]-[0062]) in the set of sensors comprises a sensor pad configured to provide contact between the sensor and skin of a head of a user (each of the electrode assembly 700 comprises a plurality of layers including layers 702, 710, 712, and 704 as shown in Fig. 7B), wherein the sensor pad comprises a polymer substrate (hydrogel conductive element 712, [0062]-[0066]: note that the hydrogel conductive element is inherently formed from a polymeric material) coated with a thin film (the conductive element 712 absorbs and holds electrolytic solution such as saline solution or other electrically conductive liquid, [0066]; in essence, given that the claim does not describe a specific material of the thin film, the saline solution or other electrically conductive liquid that permeates through the hydrogel conductive element and disposes between the hydrogel element 712 and the skin reads on the thin film);
a housing (headset 500 in Fig. 5 of the headset 302 represented in the schematic diagram of Fig. 3) configured to retain the set of sensors (Figs. 6A-6B illustrates the implementation of the headset 500 for electrically connecting each of the electrode assembly to the headset, [0059]-[0060]), wherein the housing comprises a first arm configured to bias a first sensor in the set of sensors against skin proximal to a first region of the head of the user (although not shown in Fig. 6, the headset 500 shows the arm 552 in Fig. 5 pressing against the right temporal area of the patient’s head, [0056]), wherein the housing comprises a second arm configured to bias a second sensor in the set of sensors against skin proximal to a second region of the head of the user (although not shown in Fig. 6, the headset 500 shows arm 554 in Fig. 5 pressing against the left temporal area of the patient’s head, [0056]), thus meeting claim 5); and
an electronic subsystem coupled to the set of sensors (processing system 390 coupled to the headset 302 shown in Fig. 3, [0049]), the electronic subsystem configured to receive a set of bioelectrical signals from the set of sensors ([0048]: “signals detected by the electrodes in the headset 302 are fed through a sensor interface 304 and digitized by an analog to digital converter 306 [of the processing system 390]”).
In regard to claims 2-3, Do further discloses wherein the set of sensors comprises dry sensors since the hydrogel can be in its dried state prior to introduction of saline or conductive fluid which reads on the dry sensors and the conductive fluid or saline is considered non-polarizable material. The examiner notes that these interpretations are in line with tine instant disclose ([0022] of the instant specification: “… the dry sensor pad material preferably evolves a volume of fluid (e.g., a thin film of fluid at a sensor-user interface), and can additionally or alternatively stimulates perspiration by the user at the sensor-user interface and/or attracts environmental moisture, in order to provide a continuous sensor-user interface”).
In regards to claim 4, Do further discloses wherein each sensor pad is configured to support input impedance from 1 MOhm to 1 GOhm ([0082]: the device of Do is configured to provide a large input impedance e.g., in the gigaohm range).
In regards to claim 6, Do further discloses wherein the electronics subsystem is further configured to receive an ambient signal from at least one of the first sensor or second sensor ([0081]-[0083]: electrode assembly such as shown in Fig. 7A-7B picks up noise caused by environmental interference; [0054]: specifically, one of the electrodes operate as a reference electrode which is used to compare with other signals from the electrodes); and process the set of bioelectric based on the ambient signal ([0054]: Driven Right Leg (DRL) circuitry can compensate for external effects and keep the subject’s body potential stable relative to the detection electronics. The EEG signals can be referenced to the body potential supplied by the reference electrode).
In regards to claim 8, Do further discloses wherein the electronics subsystem is further configured to generate a calibration signal by adjusting the ambient signal ([0054]: since the headset comprises a reference electrode which receives a signal to compare with signals from other electrodes, the reference electrode biases the subject’s body to a known reference potential, e.g., one half of the analog supply voltage; this bias reads on the calibration signal); and apply the calibration signal to the user through a sensor in the set of sensors ([0054]: Driven Right Leg (DRL) circuitry compensates for external effects and keep the subject’s body potential stable relative to the detection electronics. The EEG signals can be referenced to the body potential supplied by the reference electrode).
In regards to claim 9, Do further discloses wherein each sensor in the set of sensors is reversibly coupled to the housing ([0060]: The electrode mount 600 in Fig. 6A-6B is configured to provide a snap fit connection to an electrode assembly 606).
In regard to claim 10, Do further discloses wherein the set of sensors is configured to form a volume of fluid between skin of the head region of the user and the set of sensors and stimulate perspiration by the user (the examiner notes that this is an intended use limitation in which providing electrodes, which are generally warm in use, will stimulate perspiration of the skin and accumulate sweat or moisture between the skin and the electrode).
In regards to independent claim 12 and claims 17-18, Do teaches a system (abstract: “apparatus… sensing biopotential signals”; system 300 in Fig. 3), comprising:
a set of sensors (one or more electrodes mounted onto a headset 302 in exemplary schematic diagram of Fig. 3 for 10-20 electrode placement on a subject’s head, [0048], [0052], [0059]-[0060]), wherein each sensor (each of the one or more electrodes are an electrode assembly 700 as shown in Fig. 7A-7B, [0061]-[0062]) in the set of sensors is dry (the hydrogel conductive element 712 can be in its dried state prior to introduction of saline or conductive fluid which reads on the dry sensors and the conductive fluid or saline is considered non-polarizable material. The examiner notes that these interpretations are in line with tine instant disclose in [0022] of the instant specification: “… the dry sensor pad material preferably evolves a volume of fluid (e.g., a thin film of fluid at a sensor-user interface), and can additionally or alternatively stimulates perspiration by the user at the sensor-user interface and/or attracts environmental moisture, in order to provide a continuous sensor-user interface”), wherein each sensor in the set of sensors comprises an elastomer (conductive hydrogel 712, [0062]) and a sensor pad (electrode plate 702, [0062]) configured to provide contact between the sensor and skin of a head of a user (each of the electrode assembly 700 comprises a plurality of layers including layers 702, 710, 712, and 704 as shown in Fig. 7B); and
an electronic subsystem coupled to the set of sensors (processing system 390 coupled to the headset 302 shown in Fig. 3, [0049]):
the electronics subsystem is further configured to receive an ambient signal from at least one of the first sensor or second sensor ([0081]-[0083] a reference electrode such as shown in Fig. 7A-7B picks up noise caused by environmental interference);
generate a calibration signal based on the ambient signal ([0054]: the reference electrode which receives a signal to compare with signals from other electrodes, the reference electrode biases the subject’s body to a known reference potential, e.g., one half of the analog supply voltage; this bias reads on the calibration signal, thus meeting claim 17); and
apply the calibration signal to the user through a second sensor in the set of sensors ([0054]: Driven Right Leg (DRL) circuitry compensates for external effects and keep the subject’s body potential stable relative to the detection electronics. The EEG signals can be referenced to the body potential supplied by the reference electrode, thus meeting claim 18);
receive a bioelectrical signal from a third sensor in the set of sensors (the 10-20 EEG signal is acquired from the rest of the electrodes in the headset).
In regards to claims 13-14, Do further discloses wherein each sensor (electrode assembly 700 in Fig. 7A-7B, [0061]-[0062]) in the set of sensors comprises wherein the sensor pad comprises a polymer substrate (hydrogel conductive element 712, [0062]-[0066]: note that the hydrogel conductive element is inherently formed from a polymeric material) coated with a thin film (the conductive element 712 absorbs and holds electrolytic solution such as saline solution or other electrically conductive liquid, [0066]; in essence, given that the claim does not describe a specific material of the thin film, the saline solution or other electrically conductive liquid that permeates through the hydrogel conductive element and disposes between the hydrogel element 712 and the skin reads on the thin film).
In regards to claim 15, Do further discloses wherein generating the calibration signal based on the ambient signal comprises superimposing a predetermined signal onto the ambient signal ([0082]: note that the driven right leg signal which reads on the ‘calibration signal’ is a combination or superposition/superimposition of 1) the bioelectric potential signal which reads on the ‘predetermined signal’ and 2) the hum caused by environmental interference which reads on the ‘ambient signal’).
In regards to claim 19, Do further discloses wherein the sensor pad comprises an elastomeric material (each of the electrode assembly 700 comprises a plurality of layers including 712, 702, 710, and 704 as shown in Fig. 7B; the conductive glue 710 is coated onto the PCB 702 to attach the PCB to the electrode plate 702, [0062]; note that the conductive glue layer is an elastomeric material; in addition, the hydrogel element 712 is also an elastomeric material).
In regards to claim 20, Do further discloses wherein the electronic subsystem is further configured to determine a cognitive state of the user based on the bioelectric signal ([0054]: electrode headset 500 gatherer information about the subject’s cognitive information).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Do as applied to claim 1 above, and further in view of Sunderland (U.S. PGPub. No. 2014/0088394).
In regards to claim 7, Do discloses the invention substantially as claimed in claim 6/1 and discussed above.
However, Do does not disclose wherein processing the set of bioelectrical signals comprises determining a contact impedance.
Sunderland generally teaches an EEG device ([0083]: “an EEG instrument”) connected to an EEG acquisition electronics ([0083]: “an EEG instrument includes EEG acquisition electronics”) determining the quality of the contact between individual electrodes and a patient based upon a contact impedance and indicating the quality of electrode contact as good, fair and poor based upon the contact impedance ([0099], [0140]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the electronic subsystem of Do and incorporate the processing steps of obtaining a contact impedance of each of the sensors/electrodes as taught by Sunderland, as doing so indicates wither the quality of electrode contact is good, fair or poor ([0099], [0140]).
In regards to claim 16, Do discloses the invention substantially as claimed in claim 6/1 and discussed above.
However, Do does not disclose wherein processing the set of bioelectrical signals comprises determining a contact impedance for the third sensor in the set of sensors based on the bioelectric signal and the calibration signal.
Sunderland generally teaches an EEG device ([0083]: “an EEG instrument”) connected to an EEG acquisition electronics ([0083]: “an EEG instrument includes EEG acquisition electronics”) determining the quality of the contact between individual electrodes and the reference electrode and a contact impedance and indicating the quality of electrode contact as good, fair and poor based upon the contact impedance ([0099], [0140]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the electronic subsystem of Do and incorporate the processing steps of obtaining a contact impedance of each of the sensors/electrodes as taught by Sunderland, as doing so indicates wither the quality of electrode contact is good, fair or poor ([0099], [0140]). Note that signal from any electrode other than the reference electrode in essence would be based on the bioelectric signal and the calibration/driven right leg (DRL) signal.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,194,865. Although the claims at issue are not identical, they are not patentably distinct from each other as follows:
In regards to independent claim 1, Patent ‘865 claims a system (claim 1) comprising:
a set of sensors (claim 1: a set of sensors configured to detect bioelectrical signals from the user);
a housing configured to retain the set of sensors (a housing surrounding the set of sensors), wherein the housing comprising a first arm configured to bias a first sensor in the set of sensors against skin proximal to a first region of the head of the user, and the second arm configured to bias a second sensor in the set of sensors against skin proximal to a second region of the head of the user (claim 1: a housing…comprising a set of arms configured to position each sensor in the set of sensors proximal to the region of the scalp of the user upon coupling of the system to the user); and
an electronic subsystem coupled to the set of sensors, the electronics subsystem configured to receive a set of bioelectrical signals from the set of sensors (claim 1: a set of sensor interfaces configured to couple the set of sensors to the electronics subsystem through the set of arms of the housing and to amplify and shift bioelectrical signal voltages transmitted to the electronics subsystem).
However, Patent ‘865 does not claim each sensor in the set of sensors comprises a sensor pad configured to provide contact between the sensor and skin of a head of a user, wherein the sensor pad comprises a polymer substrate coated with a thin film.
Do teaches a system (abstract: “apparatus… sensing biopotential signals”; system 300 in Fig. 3), comprising: a set of sensors (headset 302 in the schematic diagram of Fig. 3 comprises one or more electrodes mounted onto the headset for 10-20 electrode placement on a subject’s head, [0048], [0052], [0059]-[0060]), wherein each sensor (electrode assembly 700 in Fig. 7A-7B, [0061]-[0062]) in the set of sensors comprises a sensor pad configured to provide contact between the sensor and skin of a head of a user (each of the electrode assembly 700 comprises a plurality of layers including 712, 702, 710, and 704 as shown in Fig. 7B), wherein the sensor pad comprises a polymer substrate (hydrogel conductive element 712, [0062]-[0066]: note that the hydrogel conductive element is inherently formed from a polymeric material) coated with a thin film (the conductive element 712 absorbs and holds electrolytic solution such as saline solution or other electrically conductive liquid, [0066]; in essence, given that the claim does not describe a specific material of the thin film, the saline solution or other electrically conductive liquid that permeates through the hydrogel conductive element and disposes between the hydrogel element 712 and the skin reads on the thin film). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify each sensor of Patent ‘865 and provide the specific structures of the sensor as taught by Do, as doing so provides a wet electrodes configured to provide low contact impedance with high quality EEG signals.
In regards to claim 12, Patent ‘865 claims a system comprising:
a set of sensors (claim 1: a set of sensors); and
an electronics subsystem (claim 1: the electronics subsystem) coupled to the set of sensors, the electronics subsystem configured to:
receive an ambient signal from a first sensor in the set of sensor (claim 1: the analog electronics subsystem comprising a hum remover that reduces noise based upon the ambient signal of the common mode sensor, wherein the hum remover is configured to sample the ambient signal of the common mode sensor);
generate a calibration signal based on the ambient signal (claim 1: superimpose the ambient signal with a square wave signal having a frequency higher than the frequency range of the bioelectrical signals to be detected to produce a calibration signal);
apply the calibration signal to the user through a second sensor of the set of sensors (claim 1:to apply the calibration signal to the user through at least one sensor of the set of sensors); and
receive a bioelectrical signal from a third sensor in the set of sensors (claim 1: a set of sensor interfaces configured to couple the set of sensors to the electronics subsystem and to amplify and shift bioelectrical signal voltages transmitted to the electronics subsystem).
However, Patent ‘865 does not each sensor in the set of sensors comprises a sensor pad configured to provide contact between the sensor and skin of a head region of a user.
Do teaches a system (abstract: “apparatus… sensing biopotential signals”; system 300 in Fig. 3), comprising: a set of sensors (headset 302 in the schematic diagram of Fig. 3 comprises one or more electrodes mounted onto the headset for 10-20 electrode placement on a subject’s head, [0048], [0052], [0059]-[0060]), wherein each sensor (electrode assembly 700 in Fig. 7A-7B, [0061]-[0062]) in the set of sensors comprises an elastomer (hydrogel element 712) and a sensor pad (electrode plate 702) configured to provide contact between the sensor and skin of a head of a user (each of the electrode assembly 700 comprises a plurality of layers including 712, 702, 710, and 704 as shown in Fig. 7B). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify each sensor of Patent ‘865 and provide the specific structures of the sensor as taught by Do, as doing so provides a wet electrodes configured to provide low contact impedance with high quality EEG signals.
Claims 1 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 10,806,400. Although the claims at issue are not identical, they are not patentably distinct from each other as follows:
In regards to independent claim 1, Patent ‘400 claims a system (claim 12: system) comprising:
a set of sensors (claim 13: a set of sensors);
a housing (claim 13: a housing comprising a set of arms configured to position the set of sensors proximal to the scalp of the user upon coupling of the system to the user); and
an electronics subsystem coupled to the set of sensors (claim 13: an electronics subsystem; the electronics subsystem coupled to the set of sensor interfaces).
However, Patent ‘400 does not claim wherein each sensor in the set of sensors comprises a sensor pad configured to provide contact between the sensor and skin of a head of a user, wherein the sensor pad comprises a polymer substrate coated with a thin film.
Do teaches a system (abstract: “apparatus… sensing biopotential signals”; system 300 in Fig. 3), comprising: a set of sensors (headset 302 in the schematic diagram of Fig. 3 comprises one or more electrodes mounted onto the headset for 10-20 electrode placement on a subject’s head, [0048], [0052], [0059]-[0060]), wherein each sensor (electrode assembly 700 in Fig. 7A-7B, [0061]-[0062]) in the set of sensors comprises a sensor pad configured to provide contact between the sensor and skin of a head of a user (each of the electrode assembly 700 comprises a plurality of layers including 712, 702, 710, and 704 as shown in Fig. 7B), wherein the sensor pad comprises a polymer substrate (hydrogel conductive element 712, [0062]-[0066]: note that the hydrogel conductive element is inherently formed from a polymeric material) coated with a thin film (the conductive element 712 absorbs and holds electrolytic solution such as saline solution or other electrically conductive liquid, [0066]; in essence, given that the claim does not describe a specific material of the thin film, the saline solution or other electrically conductive liquid that permeates through the hydrogel conductive element and disposes between the hydrogel element 712 and the skin reads on the thin film). configured to provide contact between the sensor and skin of a head of a user (each of the electrode assembly 700 comprises a plurality of layers including 712, 702, 710, and 704 as shown in Fig. 7B). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify each sensor of Patent ‘400 and provide the specific structures of the sensor as taught by Do, as doing so provides a wet electrodes configured to provide low contact impedance with high quality EEG signals.
In regards to claim 12, Patent ‘865 claims a system comprising:
A set of sensors (claim 13: a set of sensors); and
An electronics subsystem (claim 13: the electronics subsystem) coupled to the set of sensors, the electronics subsystem configured to:
Receive an ambient signal from a first sensor in the set of sensor (claim 13: the electronics subsystem comprising: an analog electronics subsystem configured to receive the preprocessed bioelectrical signals from the set of sensor interfaces);
Generate a calibration signal based on the ambient signal (claim 13: the analog electronics subsystem comprising a hum remover configured to: superimpose an ambient signal, received from the set of sensor interfaces, with a predetermined signal to produce a calibration signal);
Apply the calibration signal to the user through a second sensor of the set of sensors (claim 13: apply the calibration signal to the user through at least one sensor of the set of sensors); and
Receive a bioelectrical signal from a third sensor in the set of sensors (claim 13: a set of sensor interfaces configured to couple the set of sensors to the electronics subsystem and to amplify and shift bioelectrical signal voltages transmitted to the electronics subsystem).
However, Patent ‘865 does not each sensor in the set of sensors comprises a sensor pad configured to provide contact between the sensor and skin of a head region of a user.
Do teaches a system (abstract: “apparatus… sensing biopotential signals”; system 300 in Fig. 3), comprising: a set of sensors (headset 302 in the schematic diagram of Fig. 3 comprises one or more electrodes mounted onto the headset for 10-20 electrode placement on a subject’s head, [0048], [0052], [0059]-[0060]), wherein each sensor (electrode assembly 700 in Fig. 7A-7B, [0061]-[0062]) in the set of sensors comprises an elastomer (hydrogel element 712) and a sensor pad (electrode plate 702) configured to provide contact between the sensor and skin of a head of a user (each of the electrode assembly 700 comprises a plurality of layers including 712, 702, 710, and 704 as shown in Fig. 7B). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify each sensor of Patent ‘400 and provide the specific structures of the sensor as taught by Do, as doing so provides a wet electrodes configured to provide low contact impedance with high quality EEG signals.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 4 of U.S. Patent No. 10,028,703. Although the claims at issue are not identical, they are not patentably distinct from each other as follows:
In regards to independent claim 1, Patent ‘703 claims a system (claim 1: system) comprising:
a set of sensors (claim 1: a set of sensors), each sensor comprising a sensor pad comprising a polymer substrate coated with a thin film (claim 4: each sensor of the set of sensor includes a sensor pad composed of a hypoallergenic polyhydroxyethylmethacrylate hydrogel saturated with non-volatile electrolyte configured to provide non-polarizable contact upon coupling of the system to the user);
a housing (claim 1: a housing comprising a set of arms configured to be worn at a head region of the user), the housing comprising first and second arms (claim 1: the housing comprising a set of arms); and
an electronics subsystem coupled to the set of sensors (claim 1: an electronics subsystem; the electronics subsystem coupled to the set of sensor interfaces since it claims processing EEG signals from the set of sensors).
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 4 of U.S. Patent No. 10,028,703, and further in view of Do. Although the claims at issue are not identical, they are not patentably distinct from each other as follows:
In regards to independent claim 12, Patent ‘703 claims a system comprising: a set of sensors (claim 1: a set of sensors) comprising an elastomer (claim 1: a semi-dry hydrogel) and a sensor pad (claim 4: a sensor pad); and an electronic subsystem (claim 1: an electronics subsystem; the electronics subsystem coupled to the set of sensor interfaces since it claims processing EEG signals from the set of sensors).
However, Patent ‘703 does not disclose the processing steps of the electronic subsystem.
Do discloses a system (abstract: “apparatus… sensing biopotential signals”; system 300 in Fig. 3) similar to the claimed invention of Patent ‘703 comprising a set of sensors (one or more electrodes mounted onto a headset 302 in exemplary schematic diagram of Fig. 3 for 10-20 electrode placement on a subject’s head, [0048], [0052], [0059]-[0060]) and an electronic subsystem coupled to the set of sensors (processing system 390 coupled to the headset 302 shown in Fig. 3, [0049]). Specifically, Do discloses the electronics subsystem is further configured to receive an ambient signal from at least one of the first sensor or second sensor ([0081]-[0083] a reference electrode such as shown in Fig. 7A-7B picks up noise caused by environmental interference); generate a calibration signal based on the ambient signal ([0054]: the reference electrode which receives a signal to compare with signals from other electrodes, the reference electrode biases the subject’s body to a known reference potential, e.g., one half of the analog supply voltage; this bias reads on the calibration signal); apply the calibration signal to the user through a second sensor in the set of sensors ([0054]: Driven Right Leg (DRL) circuitry compensates for external effects and keep the subject’s body potential stable relative to the detection electronics. The EEG signals can be referenced to the body potential supplied by the reference electrode); and receive a bioelectrical signal from a third sensor in the set of sensors (the 10-20 EEG signal is acquired from the rest of the electrodes in the headset). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure the electronic subsystem of Patent ‘703 so that it is configured to provide driven right leg arrangement to reduce noise from the EEG signals acquired by the set of sensors as doing so involves routine skill in the art to remove common noise in a set of biopotential signals.
Response to Arguments
Applicant’s arguments, see Remarks filed on June 5, 2026, is fully acknowledged.
With respect to claim 1, Applicant argues that Do (U.S. PGPub. No. 2009/0105576) fails to disclose, teach, or suggest, in part, “the sensor pad comprises a polymer substrate coated with a thin film on a user-facing surface of the sensor pad”. Upon further consideration, a new interpretation of Do has been applied in above Office action. Specifically, Do discloses a hydrogel conductive element (712 in Fig. 7A and 7B) which reads on the polymer substrate since hydrogel is made from a polymeric material. And Do further discloses that the hydrogel is infused with saline solution or other electrically conductive liquid to maintain contact with the skin ([0065]). As a result, the saline solution or electrically conductive liquid forms a thin layer or film between the hydrogel and the skin. Therefore, the new interpretation of Do reads on the newly added limitation.
With respect to independent claim 12, Applicant argues that Do fails to disclose, teach, or suggest, in part, “a set of sensors, wherein each sensor in the set of sensors is dry, and wherein each sensor in the set of sensors comprises an elastomer and a sensor pad…” Upon further consideration, the Examiner notes that when the hydrogel element (712 in Figs. 7A-7B) is dried or without the saline or conductive liquid, it forms a dry sensor. In addition, the hydrogel element (712) of Do is inherently an elastomer ([0062]) and the sensor pad reads on the electrode plate (702 in Figs. 7A-7B).
Applicant’s argument that Do discloses a wet sensor and not a dry sensor is unpersuasive as this is similar to Applicant’s sensor. For example, the examiner notes paragraph [0022] of the instant specification discloses “… the dry sensor pad material preferably evolves a volume of fluid (e.g., a thin film of fluid at a sensor-user interface), and can additionally or alternatively stimulates perspiration by the user at the sensor-user interface and/or attracts environmental moisture, in order to provide a continuous sensor-user interface”). This operates similarly to Do’s electrode as fluid needs to be absorbed by the conductive element (712) in order to enhance electrode skin contact. Accordingly, the new interpretation of Do is tenable.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 6/30/2026
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