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 .
Response to Amendment
This action is in response to the remarks filed on 2/25/2026.
The amendments filed on 2/25/2026 have been entered. Accordingly claims 1-2, 6, 8, 10-11, 13-14, and 17-28 remain pending. Claims 21-28 have been newly added. Claims 3-5, 7, 9, 12, and 15-16 are cancelled.
The objections to the claims have been withdrawn in light of the amendments and the applicant’s remarks.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the target of the user as claimed in claims 1, 17, 22 and 23 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 6, 8, and 21-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitations of “determine a distance variation between the first sensing element and a target of the user… wherein the target of the user is inside a body of the user” which is not clear what the target is and how the target of the user is inside a body of the user.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 10, 11, 13-14 and 17-28 are rejected under 35 U.S.C. 103 as being unpatentable over Goodall et al (US 20170156662) in view of Li et al (An Intelligent Non-Invasive Blood Pressure Monitoring System Based on a Novel Polyvinylidene Fluoride Piezoelectric Thin Film, Micromachines (Basel). 2024 May 17;15(5):659).
Regarding claim 1, Goodall teaches flexible sensing module (“a deformable substrate; a sensor assembly” abst; “Electronics layer 107 is shown through substrate layer 105 with view 110. Included within electronics layer 107 are cells 120” [0064]; “cells 120, and the components within cells 120 such as interaction devices 780 and sensors 770” [0087]), comprising:
a first sensing element configured to detect a bio-signal of a surface of a user (“Sensors 770 in electronics assembly 113 may include sensors configured to measure orientation data. Orientation data may include data regarding acceleration, orientation, movement, angular motion, and/or rotation of attachment surface 103. For example, sensors 770 may include one or more of single-axis accelerometers, multi-axis accelerometers, single-axis gyroscopes, multi-axis gyroscopes, single-axis inclinometers, or multi-axis inclinometers. In some embodiments, combinations of these sensors are used to measure acceleration, orientation, movement, angular motion, and/or rotation. In some embodiments, sensors 770 include sensors to measure characteristics of attachment surface 103. For example, sensors 770 may be moisture sensors, electrodes, temperature sensors (e.g., thermistors, thermocouples, etc.), light sensors, hydration sensors, etc.” [0095]);
a second sensing element configured to detect (“Sensors 770 in electronics assembly 113 may include sensors configured to measure orientation data. Orientation data may include data regarding acceleration, orientation, movement, angular motion, and/or rotation of attachment surface 103. For example, sensors 770 may include one or more of single-axis accelerometers, multi-axis accelerometers, single-axis gyroscopes, multi-axis gyroscopes, single-axis inclinometers, or multi-axis inclinometers. In some embodiments, combinations of these sensors are used to measure acceleration, orientation, movement, angular motion, and/or rotation. In some embodiments, sensors 770 include sensors to measure characteristics of attachment surface 103. For example, sensors 770 may be moisture sensors, electrodes, temperature sensors (e.g., thermistors, thermocouples, etc.), light sensors, hydration sensors, etc.” [0095]) a bending curvature of the flexible sensing module when worn by the user to determine a distance variation between the first sensing element and a target of the user (“motion sensor 1010 is configured to detect one or more of a movement of a body portion and a position of the body portion. The body portion can be the portion with which the system 1000 interfaces or can be a portion proximate the portion with which the system 1000 interfaces. In an embodiment, the motion sensor 1010 generates a sense signal based on a repeated motion of the body portion. For example, the system 1000 can be positioned on a wrist of a subject and the motion sensor 1010 measures a repeated flexing or bending of the wrist, such as to move the hand or one or more fingers.” [0140]; “The substrate 1002 is configured to conform to a contour of a body portion of an individual subject (e.g., the curvature of a limb), to interface with a skin surface of the body portion, or combinations thereof. For example, the substrate 1002 can comprise a deformable (e.g., conformable, flexible, stretchable, etc.) material configured to interface with, and conform to, the body portion, including, but not limited to a skin surface of the body portion” [0182]) and to generate a first signal in response to the distance variation, wherein the target of the user is inside a body of the user (“the processor can coordinate operation of the effector 1008 based upon identification of the physiological state (e.g., pain state, motion state, etc.) of the individual subject and conditions experienced by the individual subject (e.g., rest state, motion state, within range of target values of motion regimen, outside range of target values of motion regimen, etc.)” [0249]); and
a processing element configured to calibrate the bio-signal in response to the first signal (“Control circuit 760 may also send a calibration signal to sensor 770” [0090]).
Although it is believed that Goodall teaches all the BRAOD claimed limitations, if in a narrower interpretation one argues otherwise (which the office does not concede) that in response to the distance variation, wherein the target of the user is inside a body of the user is not taught, Li reference is brought in to show the narrow interpretations and to provide compact prosecution.
In the same field of endeavor, Li teaches developing a comfortable and sustainable device for monitoring human pulse signals holds practical significance for the prevention and treatment of hypertension and cardiovascular diseases. PVDF flexible pressure sensors possess the characteristics of high sensitivity, good flexibility, and strong biocompatibility, thereby demonstrating extensive application potential in areas such as health monitoring, wearable devices, and electronic skins (abst). Changes in the geometric structure of the electrodes and dielectric layer under external loads, altering the distance between the electrodes and plates, resulting in a change in capacitance (intro, related work). Assuming the length of the arterial vessel through which blood flows between the two measurement positions is L, the relationship between Pulse Wave Velocity (PWV) and Pulse Wave Transmission Time (PTT) (3.2.2. Blood Pressure Monitoring Principle Based on PVDF Sensors section). A force gauge is used to calibrate the linear relationship between the force applied to the film and the resulting voltage. The film samples attached with medical tape are wrapped around the subject’s upper arm. By gradually tightening the medical tape, the Korotkoff sound method is used to read the voltage corresponding to diastolic and systolic pressures. These readings are then converted into corresponding pressure values using a linear equation, resulting in blood pressure measurement results in the format “diastolic pressure/systolic pressure”, with units in mmHg (4.2.2. Analysis of Intelligent Blood Pressure Monitoring Performance, section).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with as taught by Li because it offers beneficial guidance for the design and application of future intelligent health monitoring systems (abst of Li).
Regarding claim 2, Goodall teaches all the claimed limitations except for the specifics of the first sensing element is closer to the surface of the user than the second sensing element is.
However, Goodall teaches herein described subject matter sometimes illustrates different components contained within, or connected with, different other components. It is to be understood that such depicted architectures are merely exemplary, and that in fact many other architectures can be implemented which achieve the same functionality. In a conceptual sense, any arrangement of components to achieve the same functionality is effectively “associated” such that the desired functionality is achieved” [0288].
It would have been an obvious matter of design choice to provide first sensing element is closer to the surface than the second sensing element, since such a modification would have involved a mere change in the form or shape of a component as noted by Goodall that many other architectures can be implemented which achieve the same functionality. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 10, Goodall teaches sensing module (“a deformable substrate; a sensor assembly” abst; “Electronics layer 107 is shown through substrate layer 105 with view 110. Included within electronics layer 107 are cells 120” [0064]; “cells 120, and the components within cells 120 such as interaction devices 780 and sensors 770” [0087]), comprising:
flexible substrate (“a deformable substrate; a sensor assembly” abst; “attachment surface 103 is a bandage attached or to be attached to the skin or other organ. … attachment surface 103 is a covering such as a glove, finger cot, or the like” [0066]);
a first sensing element disposed on a top surface of the flexible substrate (“electronics device 100 is held in contact with attachment surface 103 through conformal contact… epidermal electronics device 100 is held in contact with attachment surface 103 through close-contact atomic forces or van der Waals interactions. … epidermal electronics device 100 is held in contact with attachment surface 103 through the use of an adhesive. The adhesive may be applied after the epidermal electronics device 100 is placed on attachment surface 103. For example, the adhesive may be a spray on bandage or may be adhesive tape. The adhesive may also be included as a component of barrier layer 109” [0067]; also see [0070]-[0072])
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and configured to detect a bio-signal, the top surface facing a surface of a user when the sensing module is worn by the user (“Sensors 770 in electronics assembly 113 may include sensors configured to measure orientation data. Orientation data may include data regarding acceleration, orientation, movement, angular motion, and/or rotation of attachment surface 103. For example, sensors 770 may include one or more of single-axis accelerometers, multi-axis accelerometers, single-axis gyroscopes, multi-axis gyroscopes, single-axis inclinometers, or multi-axis inclinometers. In some embodiments, combinations of these sensors are used to measure acceleration, orientation, movement, angular motion, and/or rotation. In some embodiments, sensors 770 include sensors to measure characteristics of attachment surface 103. For example, sensors 770 may be moisture sensors, electrodes, temperature sensors (e.g., thermistors, thermocouples, etc.), light sensors, hydration sensors, etc.” [0095]);
a processing element configured to calibrate the bio-signal in response to the first signal (“Control circuit 760 may also send a calibration signal to sensor 770” [0090]).
In another embodiments Goodall further teaches a second sensing element embedded within the flexible substrate and adjacent to a bottom surface of the flexible substrate opposite to the top surface of the flexible substrate (“Substrate layer 105 is the topmost layer relative to attachment surface 103 and protects electronics layer 107 from the external environment” [0070]), wherein a projection of the first sensing element in a direction perpendicular to the top surface of the flexible substrate is fully within the second sensing element (see re-produced fig. 1B above) the second sensing element configured to detect a deformation of the sensing module to generate a first signal (“Sensors 770 in electronics assembly 113 may include sensors configured to measure orientation data. Orientation data may include data regarding acceleration, orientation, movement, angular motion, and/or rotation of attachment surface 103. For example, sensors 770 may include one or more of single-axis accelerometers, multi-axis accelerometers, single-axis gyroscopes, multi-axis gyroscopes, single-axis inclinometers, or multi-axis inclinometers. In some embodiments, combinations of these sensors are used to measure acceleration, orientation, movement, angular motion, and/or rotation. In some embodiments, sensors 770 include sensors to measure characteristics of attachment surface 103. For example, sensors 770 may be moisture sensors, electrodes, temperature sensors (e.g., thermistors, thermocouples, etc.), light sensors, hydration sensors, etc.” [0095]).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with as taught by Goodall because allow the electronic circuits to flex without being damaged ([0063] of Goodall).
Further, in the same field of endeavor, Li teaches developing a comfortable and sustainable device for monitoring human pulse signals holds practical significance for the prevention and treatment of hypertension and cardiovascular diseases. PVDF flexible pressure sensors possess the characteristics of high sensitivity, good flexibility, and strong biocompatibility, thereby demonstrating extensive application potential in areas such as health monitoring, wearable devices, and electronic skins (abst). The sensor comprises a flexible substrate and conductive electrodes, with a piezoelectric polymer overlaid on the flexible substrate. This piezoelectric polymer can be configured on the flexible substrate (3.2.1. Method of Connecting Piezoelectric Polymers, section).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with as taught by Li because it offers beneficial guidance for the design and application of future intelligent health monitoring systems (abst of Li).
Regarding claim 11, Goodall teaches all the claimed limitations except for the specifics of the second sensing element is positioned at a center of the flexible substrate.
However, Goodall teaches herein described subject matter sometimes illustrates different components contained within, or connected with, different other components. It is to be understood that such depicted architectures are merely exemplary, and that in fact many other architectures can be implemented which achieve the same functionality. In a conceptual sense, any arrangement of components to achieve the same functionality is effectively “associated” such that the desired functionality is achieved” [0288].
It would have been an obvious matter of design choice to provide the second sensing element is positioned at a center of the flexible substrate, since such a modification would have involved a mere change in the form or shape of a component as noted by Goodall that many other architectures can be implemented which achieve the same functionality. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 13, Goodall teaches wherein the second sensing element non-overlaps the first sensing element horizontally (see re-produced Fig. 1B).
Regarding claim 14, Goodall teaches all the claimed limitations except for the specifics of the size of the second sensing element is greater than or identical to a size of the first sensing element.
However, Goodall teaches herein described subject matter sometimes illustrates different components contained within, or connected with, different other components. It is to be understood that such depicted architectures are merely exemplary, and that in fact many other architectures can be implemented which achieve the same functionality. In a conceptual sense, any arrangement of components to achieve the same functionality is effectively “associated” such that the desired functionality is achieved” [0288].
It would have been an obvious matter of design choice to provide second sensing element is greater than or identical to a size of the first sensing element, since such a modification would have involved a mere change in the form or shape of a component as noted by Goodall that many other architectures can be implemented which achieve the same functionality. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 17, Goodall teaches flexible sensing module (“a deformable substrate; a sensor assembly” abst; “Electronics layer 107 is shown through substrate layer 105 with view 110. Included within electronics layer 107 are cells 120” [0064]; “cells 120, and the components within cells 120 such as interaction devices 780 and sensors 770” [0087]), comprising:
a first sensing element configured to detect a bio-signal of a surface of a user (“Sensors 770 in electronics assembly 113 may include sensors configured to measure orientation data. Orientation data may include data regarding acceleration, orientation, movement, angular motion, and/or rotation of attachment surface 103. For example, sensors 770 may include one or more of single-axis accelerometers, multi-axis accelerometers, single-axis gyroscopes, multi-axis gyroscopes, single-axis inclinometers, or multi-axis inclinometers. In some embodiments, combinations of these sensors are used to measure acceleration, orientation, movement, angular motion, and/or rotation. In some embodiments, sensors 770 include sensors to measure characteristics of attachment surface 103. For example, sensors 770 may be moisture sensors, electrodes, temperature sensors (e.g., thermistors, thermocouples, etc.), light sensors, hydration sensors, etc.” [0095]);
a processing element configured to calibrate the bio-signal in response to a distance variation between the first sensing element and the target (“The data may be processed by a variety of techniques to estimate or calculate orientation, acceleration, movement, angular motion, rotation, angular velocity, angular acceleration, and/or position of epidermal electronics device 100… control circuit 760 may send a calibration control signal to sensor 770 to make a correction following an extraneous measurement detected by control circuit 760” [0130]; “Control circuit 760 may also send a calibration signal to sensor 770” [0090]) wherein the processing element includes a memory storing a database of correction parameters that is obtained by testing the flexible sensing module with one or more tissue phantoms, wherein the correction parameters are associated with the distance variation (“wherein the processing element includes a memory storing a database of correction parameters that is obtained by testing the flexible sensing module with one or more tissue phantoms, wherein the correction parameters are associated with the distance variation” [0130]).
Further, in the same field of endeavor, Li teaches developing a comfortable and sustainable device for monitoring human pulse signals holds practical significance for the prevention and treatment of hypertension and cardiovascular diseases. PVDF flexible pressure sensors possess the characteristics of high sensitivity, good flexibility, and strong biocompatibility, thereby demonstrating extensive application potential in areas such as health monitoring, wearable devices, and electronic skins (abst). A force gauge is used to calibrate the linear relationship between the force applied to the film and the resulting voltage. By gradually tightening the medical tape, the Korotkoff sound method is used to read the voltage corresponding to diastolic and systolic pressures. These readings are then converted into corresponding pressure values using a linear equation, resulting in blood pressure measurement results in the format “diastolic pressure/systolic pressure”, with units in mmHg. It is important to note that this method is suitable for single-measurement comparisons, while in industrial production, calibration is typically performed before products leave the factory, and continuous monitoring relies on automated electronic devices and signal processing systems (4.2.2. Analysis of Intelligent Blood Pressure Monitoring Performance, section).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with as taught by Li because it offers beneficial guidance for the design and application of future intelligent health monitoring systems (abst of Li).
Regarding claim 18, Goodall teaches a second sensing element configured to determine the distance variation (“Sensors 770 in electronics assembly 113 may include sensors configured to measure orientation data. Orientation data may include data regarding acceleration, orientation, movement, angular motion, and/or rotation of attachment surface 103. For example, sensors 770 may include one or more of single-axis accelerometers, multi-axis accelerometers, single-axis gyroscopes, multi-axis gyroscopes, single-axis inclinometers, or multi-axis inclinometers. In some embodiments, combinations of these sensors are used to measure acceleration, orientation, movement, angular motion, and/or rotation. In some embodiments, sensors 770 include sensors to measure characteristics of attachment surface 103. For example, sensors 770 may be moisture sensors, electrodes, temperature sensors (e.g., thermistors, thermocouples, etc.), light sensors, hydration sensors, etc.” [0095]).
Regarding claim 19, Goodall teaches wherein the second sensing element includes a deformation sensing film (“a piezoelectric thin film sensor” [0919]).
Regarding claim 20, Goodall teaches wherein the deformation sensing film includes a variable resistance as a function of a deformation amount (“strain sensor 3320 can include, …, a piezoresistor [variable resistance as a function of a deformation amount] strain sensor,” [0196]).
Regarding claim 21, Goodall teaches further comprising a flexible substrate supporting the first sensing element and the processing element, wherein the first sensing element disposed on a top surface of the flexible substrate, the top surface facing the surface of the user when the flexible sensing module is worn by the user (“electronics device 100 is held in contact with attachment surface 103 through conformal contact… epidermal electronics device 100 is held in contact with attachment surface 103 through close-contact atomic forces or van der Waals interactions. … epidermal electronics device 100 is held in contact with attachment surface 103 through the use of an adhesive. The adhesive may be applied after the epidermal electronics device 100 is placed on attachment surface 103. For example, the adhesive may be a spray on bandage or may be adhesive tape. The adhesive may also be included as a component of barrier layer 109” [0067]; also see [0070]-[0072])
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In another embodiments Goodall further teaches wherein the second sensing element is embedded within the flexible substrate and adjacent to a bottom surface of the flexible substrate opposite to the top surface of the flexible substrate, wherein a projection of the first sensing element in a direction perpendicular to the top surface of the flexible substrate is fully within the second sensing element (“Substrate layer 105 is the topmost layer relative to attachment surface 103 and protects electronics layer 107 from the external environment” [0070]), wherein a projection of the first sensing element in a direction perpendicular to the top surface of the flexible substrate is fully within the second sensing element (see re-produced fig. 1B above) the second sensing element configured to detect a deformation of the sensing module to generate a first signal (“Sensors 770 in electronics assembly 113 may include sensors configured to measure orientation data. Orientation data may include data regarding acceleration, orientation, movement, angular motion, and/or rotation of attachment surface 103. For example, sensors 770 may include one or more of single-axis accelerometers, multi-axis accelerometers, single-axis gyroscopes, multi-axis gyroscopes, single-axis inclinometers, or multi-axis inclinometers. In some embodiments, combinations of these sensors are used to measure acceleration, orientation, movement, angular motion, and/or rotation. In some embodiments, sensors 770 include sensors to measure characteristics of attachment surface 103. For example, sensors 770 may be moisture sensors, electrodes, temperature sensors (e.g., thermistors, thermocouples, etc.), light sensors, hydration sensors, etc.” [0095]).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with as taught by Goodall because allow the electronic circuits to flex without being damaged ([0063] of Goodall).
Further, in the same field of endeavor, Li teaches developing a comfortable and sustainable device for monitoring human pulse signals holds practical significance for the prevention and treatment of hypertension and cardiovascular diseases. PVDF flexible pressure sensors possess the characteristics of high sensitivity, good flexibility, and strong biocompatibility, thereby demonstrating extensive application potential in areas such as health monitoring, wearable devices, and electronic skins (abst). The sensor comprises a flexible substrate and conductive electrodes, with a piezoelectric polymer overlaid on the flexible substrate. This piezoelectric polymer can be configured on the flexible substrate (3.2.1. Method of Connecting Piezoelectric Polymers, section).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with as taught by Li because it offers beneficial guidance for the design and application of future intelligent health monitoring systems (abst of Li).
Goodall further teaches wherein the processing element includes a memory storing a database of correction parameters that is obtained by testing the flexible sensing module with one or more tissue phantoms, wherein the correction parameters are associated with the distance variation (“The data may be processed by a variety of techniques to estimate or calculate orientation, acceleration, movement, angular motion, rotation, angular velocity, angular acceleration, and/or position of epidermal electronics device 100… control circuit 760 may send a calibration control signal to sensor 770 to make a correction following an extraneous measurement detected by control circuit 760” [0130]; “Control circuit 760 may also send a calibration signal to sensor 770” [0090]) wherein the processing element includes a memory storing a database of correction parameters that is obtained by testing the flexible sensing module with one or more tissue phantoms, wherein the correction parameters are associated with the distance variation (“wherein the processing element includes a memory storing a database of correction parameters that is obtained by testing the flexible sensing module with one or more tissue phantoms, wherein the correction parameters are associated with the distance variation” [0130]).
Further, in the same field of endeavor, Li teaches developing a comfortable and sustainable device for monitoring human pulse signals holds practical significance for the prevention and treatment of hypertension and cardiovascular diseases. PVDF flexible pressure sensors possess the characteristics of high sensitivity, good flexibility, and strong biocompatibility, thereby demonstrating extensive application potential in areas such as health monitoring, wearable devices, and electronic skins (abst). A force gauge is used to calibrate the linear relationship between the force applied to the film and the resulting voltage. By gradually tightening the medical tape, the Korotkoff sound method is used to read the voltage corresponding to diastolic and systolic pressures. These readings are then converted into corresponding pressure values using a linear equation, resulting in blood pressure measurement results in the format “diastolic pressure/systolic pressure”, with units in mmHg. It is important to note that this method is suitable for single-measurement comparisons, while in industrial production, calibration is typically performed before products leave the factory, and continuous monitoring relies on automated electronic devices and signal processing systems (4.2.2. Analysis of Intelligent Blood Pressure Monitoring Performance, section).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with as taught by Li because it offers beneficial guidance for the design and application of future intelligent health monitoring systems (abst of Li).
Regarding claim 22, Goodall teaches wherein the second sensing element includes a resistive sensing thin film (“piezoresistor strain sensor can include a material that generates electricity upon deformation. In an embodiment, the piezoresistor strain sensor includes strip of material (e.g., a silicon nanomembrane, semiconducting material, metallic material, etc.)” [0198]), wherein a bottom surface of the second sensing element is exposed by the bottom surface of the flexible substrate, wherein the target of the user includes blood vessels, blood capillaries, muscles, or skin tissues (see fig 1 and the associated pars).
Regarding claim 23, Goodall teaches wherein the first sensing element is configured to detect targets at different locations using lights at different wavelengths (“he optical sensor 3324 is configured to measure a blood flow characteristic associated with the body portion. In an embodiment, the optical sensor 3324 is configured to measure a temperature characteristic associated with the body portion. In an embodiment, the optical sensor 3324 is configured to measure a pressure, strain, or deformation characteristic associated with the body portion (e.g., in swollen tissue). In an embodiment, the optical sensor 3324 is configured to measure a heart rate or respiratory rate. In an embodiment, the optical sensor 3324 is configured to measure at least one of transmitted light or reflected light. For example, the optical sensor 3324 can include, but is not limited to, a photodiode, a light-emitting diode (LED) (e.g., light-emitting diode 3326), an LED coordinated with a photosensor (e.g., photodetector), a fiber optic sensor (e.g., fiber optic strand, fiber Bragg Grating sensors, fluoroptic sensors, etc.), a flexible photonic sensor, an oximeter 3328 (e.g., pulse oximeter, near-infrared oximeter, etc.), an imaging device, such as a camera, or combinations… the optoelectronics include a plurality of polymer light-emitting diodes (PLEDs) configured to emit light of differing wavelengths (e.g., green, red, blue, etc.), which in combination” [0205]).
Regarding claim 24, Goodall teaches further comprising an encapsulant encapsulating the first sensing element, wherein the encapsulant fully covers the top surface of the flexible substrate and a top surface of the first sensing element (“thin layer is supported by a barrier layer and optionally encapsulated by a substrate layer. The device is configured to attach to or otherwise engage skin or other tissue” [0063]).
Regarding claim 25, Goodall teaches further comprising a battery disposed on the flexible substrate and outside of a vertical projection of the second sensing element on the flexible substrate, wherein the battery is encapsulated by the encapsulant (“Power source 740 provides electrical power to components within electronics layer 107. In one embodiment, power source 740 is a battery. For example, power source 740 may be a disposable battery, rechargeable battery” [0088]).
Regarding claim 26, Goodall teaches wherein the first sensing element is an optical transceiver, comprising a light emitter and an optical receiver, wherein the encapsulant is free from contacting the light emitter and the optical receiver (“he optical sensor 3324 is configured to measure a blood flow characteristic associated with the body portion. In an embodiment, the optical sensor 3324 is configured to measure a temperature characteristic associated with the body portion. In an embodiment, the optical sensor 3324 is configured to measure a pressure, strain, or deformation characteristic associated with the body portion (e.g., in swollen tissue). In an embodiment, the optical sensor 3324 is configured to measure a heart rate or respiratory rate. In an embodiment, the optical sensor 3324 is configured to measure at least one of transmitted light or reflected light. For example, the optical sensor 3324 can include, but is not limited to, a photodiode, a light-emitting diode (LED) (e.g., light-emitting diode 3326), an LED coordinated with a photosensor (e.g., photodetector), a fiber optic sensor (e.g., fiber optic strand, fiber Bragg Grating sensors, fluoroptic sensors, etc.), a flexible photonic sensor, an oximeter 3328 (e.g., pulse oximeter, near-infrared oximeter, etc.), an imaging device, such as a camera, or combinations… the optoelectronics include a plurality of polymer light-emitting diodes (PLEDs) configured to emit light of differing wavelengths (e.g., green, red, blue, etc.), which in combination” [0205]).
Regarding claim 27, Goodall teaches wherein the light emitter is configured to emit lights at different wavelengths the optoelectronics include a plurality of polymer light-emitting diodes (PLEDs) configured to emit light of differing wavelengths (e.g., green, red, blue, etc.), which in combination” [0205]).
Regarding claim 28, Goodall teaches wherein the processing element is configured to calibrate the bio-signal detected by the first sensing element based on a first signal detected by the second sensing element and the database of the correction parameters (“The data may be processed by a variety of techniques to estimate or calculate orientation, acceleration, movement, angular motion, rotation, angular velocity, angular acceleration, and/or position of epidermal electronics device 100… control circuit 760 may send a calibration control signal to sensor 770 to make a correction following an extraneous measurement detected by control circuit 760” [0130]; “Control circuit 760 may also send a calibration signal to sensor 770” [0090]) wherein the processing element includes a memory storing a database of correction parameters that is obtained by testing the flexible sensing module with one or more tissue phantoms, wherein the correction parameters are associated with the distance variation (“wherein the processing element includes a memory storing a database of correction parameters that is obtained by testing the flexible sensing module with one or more tissue phantoms, wherein the correction parameters are associated with the distance variation” [0130]).
Further, in the same field of endeavor, Li teaches developing a comfortable and sustainable device for monitoring human pulse signals holds practical significance for the prevention and treatment of hypertension and cardiovascular diseases. PVDF flexible pressure sensors possess the characteristics of high sensitivity, good flexibility, and strong biocompatibility, thereby demonstrating extensive application potential in areas such as health monitoring, wearable devices, and electronic skins (abst). A force gauge is used to calibrate the linear relationship between the force applied to the film and the resulting voltage. By gradually tightening the medical tape, the Korotkoff sound method is used to read the voltage corresponding to diastolic and systolic pressures. These readings are then converted into corresponding pressure values using a linear equation, resulting in blood pressure measurement results in the format “diastolic pressure/systolic pressure”, with units in mmHg. It is important to note that this method is suitable for single-measurement comparisons, while in industrial production, calibration is typically performed before products leave the factory, and continuous monitoring relies on automated electronic devices and signal processing systems (4.2.2. Analysis of Intelligent Blood Pressure Monitoring Performance, section).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with as taught by Li because it offers beneficial guidance for the design and application of future intelligent health monitoring systems (abst of Li).
Claims 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Goodall in view of Li and further in view of Datta et al (US 20220296165 A1).
Regarding claim 6, Goodall teaches a first amplifier electrically connected to the second sensing element and configured to amplify the first signal (“sense signals based upon detection of a physiological parameter of the body portion, for example, by detecting one or more electrical properties associated with biological cells or tissues, … an amplified sensor electrode that incorporates silicon metal oxide semiconductor field effect transistors (MOSFETs),” [0191]),
a first analog-to-digital converter (ADC) electrically connected between the first amplifier and the processing element, and configured to convert the first signal to digital, such that the processing element is configured to process the first signal (see sensor assembly 1004 in fig. 37 in relation to the fig. 34).
As seen above Goodall teaches all the claimed limitations except for the specifics of the first analog-to-digital converter (ADC) electrically connected between the first amplifier and the processing element.
However, in the same field of endeavor, Datta teaches on a flexible and stretchable substrate that provides a high level of pressure sensitivity (˜0.005 Pa), fast response (˜0.1 milliseconds), low hysteresis, superior operational stability and excellent fatigue properties. Ultrathin sheets of high-quality PZT may serve as the active components of capacitor-type structures that connect to the gate electrodes of MOSFETs based on nanomembranes of silicon (SiNMs). Specifically, a SiNM n-channel MOSFET amplifies the piezoelectric voltage response of the PZT and converts it to a current output via capacitance coupling [0110]. a flexible and stretchable elastomer substrate connected to SiNM n-channel MOSFET; or a first and a second frequency modulated millimeter wave (FMCW) radar sensors (claim 12 of Datta).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with analog-to-digital converter (ADC) electrically connected between the first amplifier and the processing element as taught by Datta because it is desirable to provide non-invasive monitoring devices for long-term monitoring of HF patients for early detection of acute worsening conditions ([0013] of Datta).
Regarding claim 8, Goodall teaches a second amplifier electrically connected to the first sensing element and configured to amplify the bio-signal (“sense signals based upon detection of a physiological parameter of the body portion, for example, by detecting one or more electrical properties associated with biological cells or tissues, … an amplified sensor electrode that incorporates silicon metal oxide semiconductor field effect transistors (MOSFETs),” [0191]), and
As seen above Goodall teaches all the claimed limitations except for the specifics of the a second analog-to-digital converter (ADC) electrically connected between the second amplifier and the processing element, and configured to convert the bio-signal to digital, such that the processing element is configured to process the bio-signal..
However, in the same field of endeavor, Datta teaches on a flexible and stretchable substrate that provides a high level of pressure sensitivity (˜0.005 Pa), fast response (˜0.1 milliseconds), low hysteresis, superior operational stability and excellent fatigue properties. Ultrathin sheets of high-quality PZT may serve as the active components of capacitor-type structures that connect to the gate electrodes of MOSFETs based on nanomembranes of silicon (SiNMs). Specifically, a SiNM n-channel MOSFET amplifies the piezoelectric voltage response of the PZT and converts it to a current output via capacitance coupling [0110]. a flexible and stretchable elastomer substrate connected to SiNM n-channel MOSFET; or a first and a second frequency modulated millimeter wave (FMCW) radar sensors (claim 12 of Datta).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with analog-to-digital converter (ADC) electrically connected between the first amplifier and the processing element as taught by Datta because it is desirable to provide non-invasive monitoring devices for long-term monitoring of HF patients for early detection of acute worsening conditions ([0013] of Datta).
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Prior art made record;
Zhang et al (High Signal to Noise Ratio Piezoelectric Thin Film Sensor Based on Elastomer Amplification for Ambulatory Blood Pressure Monitoring, ACS Sens.2024,9,1301−1309)
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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/SERKAN AKAR/ Primary Examiner, Art Unit 3797
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