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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 05, 2026 has been entered.
Response to Amendment
The Amendment filed January 27, 2026 has been entered. Claims 13-31 remain pending in the application.
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 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 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 13-31 are rejected under 35 U.S.C. 103 as being unpatentable over Quan et al. (US 2020/0305740 A1) (“Quan”) in view of Lewis (US 2019/0080121 A1) (“Lewis”).
Regarding claim 13, Quan discloses A circuit for measuring physiological parameters, the circuit comprising (Abstract and entire document):
a sensor circuit comprising: a sensor element substrate comprising one or more proximity sensors comprising a plurality of electrodes, wherein the sensor circuit is configured to monitor a capacitance signal between the plurality of electrodes and the skin of a user ([0039], “More specifically, the sensor circuit and electrode can capture (or sense) the capacitance changes through proximity sensing of the skin of the user (as opposed to physically deforming the device as a traditional capacitance sensor), and thereby act as or is a proximity sensor. The proximity sensing and/or capacitance changes are responsive to modulating distances between the skin of the user and the sensor circuit and/or modulating fringe field lines.” And FIG. 5B, “the four electrodes 546”),
wherein the capacitance signal is a measure of electric field modulations attributable to pulse-wave events that represent changes in pressure or blood flow in blood vessels of the user or to movement of parts of the body of the user ([0039], “The changes in capacitance carried by the electrode and respective sensor circuit are responsive to pressure and/or electric field modulations attributable to hemodynamic or pulse-wave events. More specifically, the sensor circuit and electrode can capture (or sense) the capacitance changes through proximity sensing of the skin of the user (as opposed to physically deforming the device as a traditional capacitance sensor), and thereby act as or is a proximity sensor. The proximity sensing and/or capacitance changes are responsive to modulating distances between the skin of the user and the sensor circuit and/or modulating fringe field lines.”), and
wherein the one or more proximity sensors comprise an attachment structure with a free floating foil construction and adhesive that is applied only around the perimeter of the attachment structure (FIG. 2A-2D and associated paragraphs, see at least [0060], “The electrode 214 can be in direct contact with the skin 218 or electrically insulated or isolated from the skin 218. It does not need to be mechanically coupled to the skin 218. The composition, structure and thickness of the electrical insulation can be chosen to modify the sensitivity of the sensor. Spacer structures can be used to control the distance between the electrode and the skin. The circuit may have a floating ground (e.g., the sensor circuit and/or transducer circuit can have a floating ground).”and [0064], “The spacer 217 includes one or more structures formed of a material, in which the length (e.g., the distance from the electrode to the skin surface) sets the distance between at least a portion of the sensor circuit/electrode and the skin.” And claim 16 discussing an adhesive applied only around the perimeter of the attachment structure);
a transducer circuit coupled to the sensor circuit, wherein the transducer circuit is configured to convert the monitored capacitance signal into a digital signal indicative of the monitored capacitance signal (FIG. 3, “a transducer circuit 326” and [0066], “The capacitance-to-digital converter converts the capacitance values (e.g., the relative changes) to a digital signal and outputs the digital signal to the electrical-signal sensing circuit 327, which can include or be a microcontroller or other processing circuitry.”);
a signal-sensing circuit communicably coupled to the electronics module, the signal-sensing circuit configured to receive the digital signal from the electronics module and determine at least one physiological parameter associated with the user (FIG. 3, “a transducer circuit 326” and [0066], “The capacitance-to-digital converter converts the capacitance values (e.g., the relative changes) to a digital signal and outputs the digital signal to the electrical-signal sensing circuit 327, which can include or be a microcontroller or other processing circuitry.”).
Quan fails to disclose an electronics module, comprising the transducer circuit, and communicably coupled to the one or more proximity sensors through elastically compressible re-engageable contacts; and
However, in the same field of endeavor, Lewis teaches an electronics module, comprising the transducer circuit, and communicably coupled to the one or more proximity sensors through elastically compressible re-engageable contacts (FIG. 1-2 and [0008], “The connector 110 may be an elastomeric connector, such as a ZEBRA® elastomeric electronic connector… The connector can include layers of conductive material interleaved with an insulating material such as a rubber or elastomer matrix (including silicone rubber). The conductive material can be formed of carbon, silver, gold, and other materials/combinations. In some example implementations, a layer of conductive material 112 may be formed as finely dispersed material distributed into the insulating matrix sufficient to produce conductivity.” And [0011], “Dimensions of the connector 110 can be tailored to fit the device 102. Elastomeric connectors 110 provide a shock absorption effect (e.g., damping sounds and vibration from removable panels of the device 102), and can create a gasket-like seal between surfaces of the device 102. The connector 110 can be tailored to enable a desired level of deformation/compression (e.g., 10-20% compression/reduction in height) to provide good contact with the electrodes 120.”); and
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the circuit as taught by Quan to include an electronics module, comprising the transducer circuit, and communicably coupled to the one or more proximity sensors through elastically compressible re-engageable contacts as taught by Lewis to provide good contact ([0011], “The connector 110 can be tailored to enable a desired level of deformation/compression (e.g., 10-20% compression/reduction in height) to provide good contact with the electrodes 120.”).
Regarding claim 14, Quan discloses The circuit of claim 13, wherein the at least one physiological parameter, determined by the signal-sensing circuit, comprises blood pressure, systolic, diastolic, mean arterial pressure, pulse pressure, respiration rate, or combinations thereof, and wherein the at least one physiological parameter is processed to extract variabilities, event probabilities, or trends ([0038], “As specific examples, the pulse-waveform can be processed to determine a heart rate, blood pressure, arterial stiffness, and/or blood volume. The electrode can be in contact with the skin of the user and/or in proximity. In some examples, the electrode can be sufficiently close to the user's skin for electrically sensing the hemodynamic or pulse-wave events via the capacitance changes carried by the electrode (or plurality of electrodes).” And [0091 – 0093] discussing comparing to reference data).
Regarding claim 15, Quan discloses The circuit of claim 13, wherein the signal-sensing circuit is configured to provide a quality metric based on sensor data, wherein the quality metric is used to filter extracted blood pressure values or to estimate a confidence level for the extracted blood pressure values in subsequent sensor data ([0066], “The electrical-signal sensing circuit 327, using power provided by the power supply 328, measures and/or records an arterial pulse-waveform and optionally conditions the signal, evaluates the quality of the data, and/or determines one or more hemodynamic parameters.”).
Regarding claim 16, Quan discloses A circuit for measuring physiological parameters, the circuit comprising (Abstract and entire document):
a sensor circuit comprising a sensor element substrate comprising one or more proximity sensors comprising a plurality of electrodes, wherein the sensor circuit is configured to monitor a capacitance signal between the plurality of electrodes and the skin of a user ([0039], “More specifically, the sensor circuit and electrode can capture (or sense) the capacitance changes through proximity sensing of the skin of the user (as opposed to physically deforming the device as a traditional capacitance sensor), and thereby act as or is a proximity sensor. The proximity sensing and/or capacitance changes are responsive to modulating distances between the skin of the user and the sensor circuit and/or modulating fringe field lines.” And FIG. 5B, “the four electrodes 546”),
wherein the capacitance signal is a measure of electric field modulations attributable to pulse-wave events that represent changes in pressure or blood flow in blood vessels of the user, or to movements of parts of the body of the user ([0039], “The changes in capacitance carried by the electrode and respective sensor circuit are responsive to pressure and/or electric field modulations attributable to hemodynamic or pulse-wave events. More specifically, the sensor circuit and electrode can capture (or sense) the capacitance changes through proximity sensing of the skin of the user (as opposed to physically deforming the device as a traditional capacitance sensor), and thereby act as or is a proximity sensor. The proximity sensing and/or capacitance changes are responsive to modulating distances between the skin of the user and the sensor circuit and/or modulating fringe field lines.”); and
wherein the one or more proximity sensors comprise an attachment structure with a free floating foil construction and adhesive that is applied only around the perimeter of the attachment structure (FIG. 2A-2D and associated paragraphs, see at least [0060], “The electrode 214 can be in direct contact with the skin 218 or electrically insulated or isolated from the skin 218. It does not need to be mechanically coupled to the skin 218. The composition, structure and thickness of the electrical insulation can be chosen to modify the sensitivity of the sensor. Spacer structures can be used to control the distance between the electrode and the skin. The circuit may have a floating ground (e.g., the sensor circuit and/or transducer circuit can have a floating ground).”and [0064], “The spacer 217 includes one or more structures formed of a material, in which the length (e.g., the distance from the electrode to the skin surface) sets the distance between at least a portion of the sensor circuit/electrode and the skin.” And claim 16 discussing an adhesive applied only around the perimeter of the attachment structure);
a transducer circuit coupled to the sensor circuit, wherein the transducer circuit is configured to convert the monitored capacitance signal into digital signals indicative of the monitored capacitance signal (FIG. 3, “a transducer circuit 326” and [0066], “The capacitance-to-digital converter converts the capacitance values (e.g., the relative changes) to a digital signal and outputs the digital signal to the electrical-signal sensing circuit 327, which can include or be a microcontroller or other processing circuitry.”); and
a signal-sensing circuit communicably coupled to the electronics module, the signal-sensing circuit configured to implement blood pressure or other hemodynamic or physiological models (FIG. 3, “a transducer circuit 326” and [0066], “The capacitance-to-digital converter converts the capacitance values (e.g., the relative changes) to a digital signal and outputs the digital signal to the electrical-signal sensing circuit 327, which can include or be a microcontroller or other processing circuitry.”).
Quan fails to disclose an electronics module, comprising the transducer circuit, and communicably coupled to the one or more proximity sensors through elastically compressible re-engageable contacts; and
However, in the same field of endeavor, Lewis teaches an electronics module, comprising the transducer circuit, and communicably coupled to the one or more proximity sensors through elastically compressible re-engageable contacts (FIG. 1-2 and [0008], “The connector 110 may be an elastomeric connector, such as a ZEBRA® elastomeric electronic connector… The connector can include layers of conductive material interleaved with an insulating material such as a rubber or elastomer matrix (including silicone rubber). The conductive material can be formed of carbon, silver, gold, and other materials/combinations. In some example implementations, a layer of conductive material 112 may be formed as finely dispersed material distributed into the insulating matrix sufficient to produce conductivity.” And [0011], “Dimensions of the connector 110 can be tailored to fit the device 102. Elastomeric connectors 110 provide a shock absorption effect (e.g., damping sounds and vibration from removable panels of the device 102), and can create a gasket-like seal between surfaces of the device 102. The connector 110 can be tailored to enable a desired level of deformation/compression (e.g., 10-20% compression/reduction in height) to provide good contact with the electrodes 120.”),
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the circuit as taught by Quan to include an electronics module, comprising the transducer circuit, and communicably coupled to the one or more proximity sensors through elastically compressible re-engageable contacts as taught by Lewis to provide good contact ([0011], “The connector 110 can be tailored to enable a desired level of deformation/compression (e.g., 10-20% compression/reduction in height) to provide good contact with the electrodes 120.”).
Regarding claim 17, Quan discloses The circuit of claim 16, wherein the signal-sensing circuit is configured to convert the capacitance signal to a format that can be displayed on an external monitor and/or processed and stored on an external data system ([0066], “The electrical-signal sensing circuit 327 can output the waveform and other optional data to the CPU 334 via the communication circuit 330 (e.g., the integral transceiver) and antenna 332.”).
Regarding claim 18, Quan discloses The circuit of claim 16, wherein the signal-sensing circuit is configured to employ input obtained from a prescribed start-up regimen where the proximity sensor is applied and then used in multiple positions ([0107], “As illustrated and previously described, the pulse-waveform can be used to determine various hemodynamic parameters. For example, the shape and other features of the pulse-waveform can be correlated to blood pressure. In other embodiments, the heart rate and heart variability can be obtained by determining the timings of each pulse. Further, the changes in blood pressure can be monitored by first calibrating the data (such as with arterial lines that are calibrated against inflatable cuff data).”).
Regarding claim 19, the same rejections as applied to claims 13 and 16 apply to claim 19.
Regarding claim 20, Quan discloses The method of claim 19, further comprising reducing motion artifacts with an accessory device ([0044], “The signals can be processed using one or more bandpass filters or other signal processing techniques. For example, the signal can be filtered either digitally or through a circuit design used to minimize artifacts due to factors such as pressure changes or motion due to breathing, arm motions, and external vibrations.”).
Regarding claim 21, Quan discloses The circuit of claim 13, wherein the one or more proximity sensors are further comprising: a first dielectric layer comprising an inner surface and an outer surface (FIG. 5B, “544 insulating layer”);
an electrically conductive layer positioned proximate to one of the inner surface or the outer surface of the first dielectric layer (FIG. 5B and [0081], “and another insulating layer 544 with a conductive material on the outer surface (e.g., on the surface that is opposite and/or not proximal to the spacer layer 545).”); and
the plurality of electrodes comprising an outer surface, the outer surface of the plurality of electrodes positioned proximate the inner surface of the first dielectric layer (FIG. 5A and 5b “549, 550 electrodes” and “546 electrodes” the figures showing the outer surface and the proximate requirement of the claim.),
wherein the outer surface of the at least one electrode and the electrically conductive layer define a gap (As shown in FIG. 5A-5B).
Regarding claim 22, Quan discloses The circuit of claim 21, wherein the one or more proximity sensors are further comprising a foam layer (FIG. 5B, “spacer layer 545” and [0076], “the insulating layer 443 with a conductive material is formed of 12 micron PET with around or greater than 2 optical density evaporated aluminum (such as commercially available Celplast Cel-Met 48 g) and the spacer layer is formed of a layer of foam tape (such as commercially available Nexcare 731). Individual electrodes can be 0.625 mm wide with 0.625 mm spaces between them.”).
Regarding claim 23, Quan discloses The circuit of claim 21, wherein the one or more proximity sensors are further comprising a sealant layer disposed over a sensing surface of the proximity sensor ([0043], “In specific embodiments, the electrode(s) is encapsulated with a dielectric layer (e.g., an encapsulant).” And [0074], “The array of sensors (e.g., the electrodes) can be packaged in insulating material (e.g., dielectric material) to provide environmental stability and resistance to moisture.”).
Regarding claim 24, Quan discloses The circuit of claim 21, wherein the electrically conductive layer is positioned proximate the inner surface of the first dielectric layer; and further comprising a second dielectric layer disposed between the plurality of electrodes and the electrically conductive layer (FIG. 5B, “spacer layer 545” and “proximate” being interpreted as “near”).
Regarding claim 25, Quan discloses The circuit of claim 24, Quan does not explicitly disclose wherein the second dielectric layer has a thickness less than 3um.
However, Quan discloses ([0043], “When a plurality of electrodes are used, the dielectric layer on each of the plurality of electrodes can have different structural characteristics to modulate signal sensitivity of each electrode. Example characteristics can include thickness of the dielectric layer, composition of the dielectric material used, structures, and resistivity values, among other characteristics.” And [0051], “Further, the dielectric layer can have different thicknesses, such as on the order of 5 to 250 microns. Although embodiments are not so limited, and the dielectric layers can be thicker or thinner to affect the stiffness and/or comfortability of wearing the apparatus for the user or to modulate the sensitivity of the sensor circuit 103.”)
it would have been an obvious matter of design choice to modify Quan to include a thickness less than 3 um since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Absent a teaching as to criticality that the particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 26, Quan discloses The circuit of claim 24, wherein the second dielectric layer has a textured surface ([0064], “Although the embodiment of FIG. 2D illustrates one spacer having rectangular shape, embodiments are not so limited and can include more than one spacer and different shaped spacers, such as a layer of textured and/or structured material.”).
Regarding claim 27, Quan discloses The circuit of claim 16, wherein the one or more proximity sensors are further comprising: a first dielectric layer comprising an inner surface and an outer surface (FIG. 5B, “544 insulating layer”);
an electrically conductive layer positioned proximate to one of the inner surface or the outer surface of the first dielectric layer (FIG. 5B and [0081], “and another insulating layer 544 with a conductive material on the outer surface (e.g., on the surface that is opposite and/or not proximal to the spacer layer 545).”);
a sensing electrode of the plurality of electrodes, positioned proximate the inner surface of the first dielectric layer, the sensing electrode comprising an inner surface and an outer surface, the outer surface of the sensing electrode positioned proximate the inner surface of the first dielectric layer, wherein the outer surface of the sensing electrode and the electrically conductive layer define a first gap (FIG. 5A and 5b “549, 550 electrodes” and “546 electrodes” the figures showing the outer surface and the proximate requirement of the claim.); and
a reference electrode of the plurality of electrodes disposed relative to the sensing electrode, the reference electrode positioned proximate the inner surface of the first dielectric layer, the reference electrode comprising an inner surface and an outer surface, the outer surface of the reference electrode positioned proximate the inner surface of the first dielectric layer, wherein the outer surface of the reference electrode and the electrically conductive layer define a second gap (FIG. 5A and 5b “549, 550 electrodes” and “546 electrodes” which are considered suitable as reference electrodes, as they are mechanically isolated from the other sensing electrodes).
Regarding claim 28, Quan discloses The circuit of claim 27, wherein the reference electrode is disposed laterally relative to the sensing electrode, stacked relative to the sensing electrode, or mechanically isolated from the sensing electrode (FIG. 5A-5B, “543 542 541 insulation layer, also [0080], “The insulating layers 541, 543 can be slit at one or more location(s) 542 to mechanically isolate individual sensor circuits and to increase the conformability of the packed sensors to the underlying substrate.”).
Regarding claim 29, Quan discloses The circuit of claim 27, further comprising a fifth dielectric layer disposed between the reference electrode and the first dielectric layer (FIG. 5A-5B, “543 542 541 insulation layer, also [0043], “In specific embodiments, the electrode(s) is encapsulated with a dielectric layer (e.g., an encapsulant).” And [0074], “The array of sensors (e.g., the electrodes) can be packaged in insulating material (e.g., dielectric material) to provide environmental stability and resistance to moisture.”).
Regarding claim 30, Quan discloses The circuit of claim 27, further comprising a sixth dielectric layer disposed between the sensing electrode and the first dielectric layer (FIG. 5A-5B, “543 542 541 insulation layer, also [0043], “In specific embodiments, the electrode(s) is encapsulated with a dielectric layer (e.g., an encapsulant).” And [0074], “The array of sensors (e.g., the electrodes) can be packaged in insulating material (e.g., dielectric material) to provide environmental stability and resistance to moisture.”).
Regarding claim 31, Quan discloses The circuit of claim 27, further comprising: a substrate layer, wherein the sensing electrode and the reference electrode are positioned on opposite sides of the substrate layer ([0075], “The conductive layer may alternatively be sandwiched between two insulating layers. The conductive material can include, for example, aluminum, gold, carbon, or copper that has been printed, evaporated, sputtered, or plated onto a non-conductive substrate (e.g., of PET or polyimide substrate).”).
Response to Arguments
Applicant's arguments filed January 27, 2026 have been fully considered but they are not persuasive.
With respect to the arguments regarding the 103 rejections and Quan and Lewis, the arguments are not persuasive. Quan discloses “wherein the one or more proximity sensors comprise an attachment structure with a free floating foil construction and adhesive that is applied only around the perimeter of the attachment structure” see at least FIG. 2A-2D and associated paragraphs, see at least [0060], “The electrode 214 can be in direct contact with the skin 218 or electrically insulated or isolated from the skin 218. It does not need to be mechanically coupled to the skin 218. The composition, structure and thickness of the electrical insulation can be chosen to modify the sensitivity of the sensor. Spacer structures can be used to control the distance between the electrode and the skin. The circuit may have a floating ground (e.g., the sensor circuit and/or transducer circuit can have a floating ground).”and [0064], “The spacer 217 includes one or more structures formed of a material, in which the length (e.g., the distance from the electrode to the skin surface) sets the distance between at least a portion of the sensor circuit/electrode and the skin.” And see further claim 16 discussing an adhesive applied only around the perimeter of the attachment structure. Thus, Quan discloses this limitation and the arguments are not persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, to provide good contact ([0011], “The connector 110 can be tailored to enable a desired level of deformation/compression (e.g., 10-20% compression/reduction in height) to provide good contact with the electrodes 120.”). the specific tailoring of the device allows for desirable traits, it is thus a teaching, suggestion, or motivation. Thus, the arguments are not persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rahman, Md. Saifur. (2008). Bio-Signals and Transducers. Proceedings of the Short Course on Biomedical Instrumentation. 1. 5.1–5.19 & 5A.1 – 5A.4. (“Rahman”). Rahman additionally discloses a free floating foil electrode having adhesive around the outer perimeter, as claimed.
Narasimhan et al. (US 2017/0086686 A1) (“Narasimhan”). Additionally disclosing relevant material to the free floating electrodes, dielectrics, spacing and the contacts.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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/JOSEPH A TOMBERS/Examiner, Art Unit 3791