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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/19/2026 and 08/24/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant's arguments filed 09/21/2026 have been fully considered but they are not persuasive.
Applicant argues on page 16 of the remarks filed 09/21/2026 that “[t]he cited Al-Ali reference in no way discloses actively provoking a skin response by emitting electromagnetic waves, such as light waves, into a tissue...” Examiner respectfully disagrees.
With respect to the cited argument, applicant’s specification, at paragraph [0023], discloses that applicant’s device relies on a change in light reflectance of the skin (or within subcutaneous layers) in response to the presence of some compound, chemical, component or other analyte, such as glucose. Reference Al-Ali, at paragraph [0252], informs that the skin contains skin layers of tissue to include the epidermis (top layer), the dermis located below the epidermis, and the subcutaneous tissue that lies beneath the dermis which is also known in the art as the hypodermis (see Fig. 26A). Al-Ali teaches that the emission of light must reach and or interact with tissues, such as the arterial blood in the dermis as the epidermis typical does not contain blood vessels, wherein the attenuated and reflected light arrives at detectors. Al-Ali further teaches that data representing a change in the absorption of particular wavelengths of light is a function of the changes in body tissue resulting from pulsing blood (see paragraph [0099]).
Similarly, Ferber discloses that the energy transmitter 204 and the energy receiver 206 may be secured to the wearable member such that the energy transmitter and the energy receiver may make contact or be in proximity with tissues (e.g., skin) of a user (see paragraph [0090]) and that the energy receiver 206 may detect energy associated with the energy provided by the LEDs from tissues (e.g., skin) of the user (see paragraph [0093]). Therefore, one having ordinary skill the art would recognize the teaching of Al-Ali and Ferber to include actively provoking a skin response by emitting electromagnetic waves, such as light waves, into a tissue.
Continuing on page 16 of the remarks, applicant argues that Al-Ali does not disclose emitting electromagnetic waves, such as light waves, into a tissue, in a pattern of varying wavelengths, frequencies, durations, intervals, and intensities. Examiner respectfully disagrees.
Al-Ali discloses emitting electromagnetic waves, such as light waves, into a tissue, in a pattern of varying wavelengths (paragraph [0270], emitters can transmit optical radiation of a plurality of wavelengths into a tissue site), frequencies (as known in the art, wavelength and frequency are inversely related; thus, changing one changes the other), and intensities (paragraph [0305], intensity signals of the second wavelength (red) and the third wavelength (infrared)).
As indicated in the previous Office Action, Al-Ali does not specifically disclose emitting electromagnetic waves in a pattern of varying durations and intervals. However, Ferber not only discloses the missing elements of Al-Ali, but all the aforementioned claimed elements. See paragraph [0100], where Ferber discloses that energy transmitter 204 is configured to generate energy such that energy at different wavelengths (thus, different frequencies as known in the art) is generated sequentially (at a predetermined intensity, see paragraph [0180]) and/or periodically where energy is generated at each particular wavelength until energy at all wavelengths of the set is generated.
Al-Ali further discloses that an analyte detection and/or analysis can provide information such as glucose (see paragraph [0398]). However, as indicated in the previous rejection, Al-Ali does not specifically disclose employing an ANN model generated by Machine Learning for analyzing the characteristic skin response so as to derive a glucose concentration therefrom. Contrary to applicant’s argument on page 17 of the remarks that none of the cited references teaches this deficiency, Mehnert discloses Machine Learning to analyze and/or process sensor data and determine a blood sugar level measurement.
For the above reasons, the rejection is maintained.
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.
Claim 1 is 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 limitation "due to a presence of within the tissue" in line 11. It appears the applicant intended to write "due to a presence of glucose within the tissue.”
Claim 1 recites the limitation "the first set of photoemitters" in line 29. There is insufficient antecedent basis for this limitation in the claim. It appears the applicant intended to write "the first set of emitters.”
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 22-28, 33, 35, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali et al. (Pub. No.: US 2023/0058052, Applicant’s IDS filed 12/30/2025) in view of Ferber et al. (Pub. No.: US 2021/0145334, Applicant’s IDS filed 11/10/2025) and further in view of Bosua et al. (Pat. No.: US 11,284,819, Applicant’s IDS filed 08/19/2026).
Consider claim 22, Al-Ali discloses a continuous non-invasive sensor system (paragraph [0250], Figs. 1A-1H, wearable device 10 including a physiological parameter measurement sensor or module 100 performing continuous monitoring, wherein the sensor is non-invasive, see paragraph [0255]), the sensor system for employing spectral related characteristic skin response data from which a concentration of glucose being present in a tissue of a body of a wearer of the multi-sensing detection device (paragraph [0250], Figs. 1A-1H, physiological parameter measurement sensor or module 100) may be determined (paragraphs [0006], [0098], sensor has at least one emitter that transmits optical radiation of one or more wavelengths into a tissue site and at least one detector that responds to the intensity of the optical radiation to measure an indication of the wearer's physiological parameters including glucose, see paragraph [0250]), the system comprising:
a multi-sensing detection device (paragraph [0250], Figs. 1A-1H, physiological parameter measurement sensor or module 100) being configured for being positioned proximate the skin when the multi-sensing detection device is coupled to the body of the wearer (paragraph [0252], Figs. 1B, 1F, device 10 being worn on the wrist 2 of the wearer, with the physiological parameter measurement sensor or module 100 facing the wrist 2), the multi-sensing detection device having a sensor unit (paragraphs [0251], [0006], Figs., 1E, 1H, plurality of light emitters 104 (such as LEDs) and one or more photodetectors (also referred to as “detectors”) 106) for detecting glucose being present within the wearer's tissue (paragraph [0250], measure an indication of the wearer's physiological parameters including glucose), the multi-sensing detection device comprising:
a housing (paragraph [0251], Figs. 1G, 1H, 3, housing 101) configured for encasing the sensor unit (paragraph [0251], housing 101 can include an opening sized to retain the physiological parameter measurement sensor or module 100);
a glucose sensor unit (paragraphs [0251], [0006], Figs., 1E, 1H, plurality of light emitters 104 (such as LEDs) and one or more photodetectors (also referred to as “detectors”) 106) for detecting a skin characteristic response of one or more tissues of the body due to a presence of within the tissue (paragraph [0270], detectors can respond to the intensity of the optical radiation reflected from the tissue site after absorption and measure an indication of the wearer's physiological parameters including glucose, see paragraph [0250]), the sensor unit comprising:
a printed circuit board (paragraph [0280], Fig. 8F, PCB 816) having a first (paragraph [0280], Fig. 8F, detector group 106a and emitter group 104a) and a second sensor array (paragraph [0280], Fig. 8F, detector group 106b and emitter group 104b) coupled therewith, each sensor array including a number of emitters and one or more receivers (paragraph [0280], Fig. 8F, detector group 106a and emitter group 104a and detector group 106b and emitter group 104b), each sensor array being arranged on the printed circuit board within the housing so as to be proximate-the user's skin when the multi-sensing detection device is positioned on the user's body (paragraph [0283], Figs. 7B-7E, physiological parameter measurement sensor or module 100 can include a skin-interfacing light transmissive cover 102 that encloses the first side of the PCB 116), the one or more emitters being configured to emit, in a plurality of cycles, at a predetermined frequency, the tissue of the user's body (paragraph [0302], Fig. 13B, each of the emitters can be configured to emit light of a different wavelength (frequency domain pulse rate (FDPR) information obtained from the wavelength, see paragraph [0314]) than the other emitters wherein the emitters can transmit optical radiation of a plurality of wavelengths into a tissue site, see paragraph [0270]), so as to provoke a skin response therein (paragraph [0252], the emission of light must reach and or interact with tissues, such as the arterial blood in the dermis, wherein the attenuated and reflected light arrives at detectors), and each of the one or more receivers configured to receive a return of the emission back from the user's tissue and to generate a return signal in response to collecting the return emission (paragraph [0270], the detectors can respond to the intensity of the optical radiation (which can be reflected from the tissue site) after absorption by pulsatile arterial blood flowing within the tissue site),
the first sensor array comprising a first set of emitters positioned so as to be proximate at least a first receiver (paragraph [0280], Fig. 8F, detector group 106a and emitter group 104a) and being configured for directing emissions out of the housing so as to penetrate a determined depth within the tissue of the user's body (paragraph [0270], the emitters can transmit optical radiation of a plurality of wavelengths into a tissue site wherein light travels through a certain depth of the tissue before being detected, see paragraph [0306]), the first set of emitters each configured for being activated individually or collectively (paragraph [0302], Fig. 13B, each of the emitters can be configured to emit light of a different wavelength than the other emitters and LED drivers can selectively drive some but not all the LEDs), wherein the first receiver is configured for detecting the emissions of the first set of photoemitters returned back from the body's tissues (paragraph [0270], the detectors can respond to the intensity of the optical radiation (which can be reflected from the tissue site) after absorption by pulsatile arterial blood flowing within the tissue site), and
the second sensor array comprising a second set of a number of additional emitters positioned so as to be proximate at least a second receiver (paragraph [0280], Fig. 8F, detector group 106b and emitter group 104b), wherein the second receiver is configured for detecting emissions of the number of additional emitters returned back from the body's tissues (paragraph [0270], the detectors can respond to the intensity of the optical radiation (which can be reflected from the tissue site) after absorption by pulsatile arterial blood flowing within the tissue site), collectively the emitters of the first and second sensory arrays being configured for directing their emissions of respective wavelengths into the tissue of the wearer (paragraph [0302], Fig. 13B, each of the emitters can be configured to emit light of a different wavelength than the other emitters wherein the emitters can transmit optical radiation of a plurality of wavelengths into a tissue site, see paragraph [0270]), and the at least first and second receivers being configured for collecting the returned wavelengths back form the body tissue so as to generate the return signal (paragraph [0270], the detectors can respond to the intensity of the optical radiation (which can be reflected from the tissue site) after absorption by pulsatile arterial blood flowing within the tissue site),
the printed circuit board further comprising an analog to digital converter coupled to the at least first and second receivers (paragraph [0297], Fig. 11D, analog-digital converter 1098 on conditioning circuitry 1088 of module PCB 116 receiving analog signals of the emitters 104 and the detectors 106), the analog to digital converter being configured for converting the return signal to digital signal data, and a communications module for transmitting the digital signal data (paragraph [0297], Fig. 11D, analog-digital converter 1098 can output a digital signal based on the analog signals from the optical sensor including the emitters 104, the detectors 106);
a control unit coupled to the printed circuit board (paragraph [0301], Fig. 11C, LED driver circuitry 1086 of the module PCB 116), the control unit configured to generate a pattern for dynamic emitter activation, whereby each emitter of the first and second sensor arrays may be activated individually or collectively in one or more of a predetermined order (paragraph [0301], Fig. 13A, the LED driver circuitry 1086 can include an emitter switch matrix 1085 configured to drive any of the emitters (or emitter groups) that are selected to be turned on or turn off any of the emitters (or emitter groups) that are selected to be turned off), a predetermined frequency (paragraph [0314], frequency domain pulse rate (FDPR) information obtained from the wavelength), and a predetermined intensity (paragraph [0306], comparison of the intensity signals of the fourth wavelength and a different wavelength).
Al-Ali does not specifically disclose whereby each emitter of the first and second sensor arrays may include being activated individually or collectively in one or more of a predetermined order, a predetermined frequency, a predetermined intensity, and a predetermined time interval.
Ferber discloses whereby each emitter of the first and second sensor arrays may include being activated individually or collectively in one or more of a predetermined order, a predetermined frequency, a predetermined intensity, and a predetermined time interval (paragraph [0100], energy transmitter 204 is configured to generate energy such that energy at different wavelengths (thus, different frequencies as known in the art) is generated sequentially (at a predetermined intensity, see paragraph [0180]) and/or periodically where energy is generated at each particular wavelength until energy at all wavelengths of the set is generated).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the group of emitters as disclosed by Al-Ali with the energy transmitters as taught by Ferber in order that a new generation period is made to start thereby allowing for multiple measurements, (Ferber, paragraph [0100]).
The combination of Al-Ali and Ferber discloses a server system (Fig. 2, remote server 217) for receiving the digital signal data from the multi-sensing detection device (paragraph [0258], Fig. 2, wearable device 10 can establish connection via the computing network 212 to a remote server with a database 217).
The combination of Al-Ali and Ferber does not specifically disclose the server system being configured for performing one or more of optical, microwave, and near-infrared spectroscopy so as to analyze the digital signal data in order to produce the characteristic skin response data, and for analyzing the characteristic skin response data so as to thereby determine the concentration of an analyte being present in the tissue of the body of the wearer.
Bosua discloses the server system (col. 10, line 63 to col. 11, line 16, Fig. 1, remote server 27) being configured for performing one or more of optical, microwave, and near-infrared spectroscopy so as to analyze the digital signal data in order to produce the characteristic skin response data (col. 5, lines 1-10, analyte data may be collected using spectroscopic techniques using the microwave frequency range or optical frequencies, and near-infrared wavelengths as emission of wavelengths that are not in the human visible spectrum are not limited to infrared wavelengths, see col. 18, lines 40-67), and for analyzing the characteristic skin response data so as to thereby determine the concentration of an analyte being present in the tissue of the body of the wearer (col. 10, line 63 to col. 11, line 16, Fig. 1, remote server 27 may process (or further process) the signals that controller 19 receives from receiver circuit 17 (see Fig. 1) to detect the analyte(s) 9 and develop the analyte database wherein data analyzer 218 functions to analyze the received analyte data to determine the presence of the analyte(s) and/or the concentration of the analyte(s), see col. 23, line 64 to col. 24, line 4, Fig. 15).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the remote server as disclosed by the combination of Al-Ali and Ferber with the remote server as taught by Bosua to provide remote service to detect analytes (Bosua, col. 10, line 63 to col. 11, line 16).
Consider claim 35, Al-Ali discloses a continuous non-invasive sensor system (paragraph [0250], Figs. 1A-1H, wearable device 10 including a physiological parameter measurement sensor or module 100 performing continuous monitoring, wherein the sensor is non-invasive, see paragraph [0255]) having a multi-sensing detection device (paragraph [0250], Figs. 1A-1H, physiological parameter measurement sensor or module 100), the sensor system for generating a characteristic response within the skin and for performing one or more of optical, microwave, and near-infrared spectroscopy on data generated from the characteristic skin response so as to produce characteristic skin response data from which a concentration of glucose being present in a tissue of a body of a wearer of the multi-sensing detection device may be determined (paragraphs [0006], [0098], sensor has at least one emitter that transmits optical radiation of one or more wavelengths into a tissue site and at least one detector that responds to the intensity of the optical radiation to measure an indication of the wearer's physiological parameters including glucose, see paragraph [0250]), the system comprising:
a multi-sensing detection device (paragraph [0250], Figs. 1A-1H, physiological parameter measurement sensor or module 100) being configured for being positioned proximate the skin when the multi-sensing detection device is coupled to the body of the wearer (paragraph [0252], Figs. 1B, 1F, device 10 being worn on the wrist 2 of the wearer, with the physiological parameter measurement sensor or module 100 facing the wrist 2), the multi-sensing detection device having a glucose sensor unit (paragraphs [0251], [0006], Figs., 1E, 1H, plurality of light emitters 104 (such as LEDs) and one or more photodetectors (also referred to as “detectors”) 106) for detecting glucose being present within the wearer's tissue (paragraph [0250], measure an indication of the wearer's physiological parameters including glucose), the multi-sensing detection device comprising:
a housing (paragraph [0251], Figs. 1G, 1H, 3, housing 101) configured for encasing the glucose sensor unit (paragraph [0251], housing 101 can include an opening sized to retain the physiological parameter measurement sensor or module 100);
a glucose sensor unit (paragraphs [0251], [0006], Figs., 1E, 1H, plurality of light emitters 104 (such as LEDs) and one or more photodetectors (also referred to as “detectors”) 106) for generating and detecting a characteristic skin response of one or more tissues of the body due to a presence of glucose within the tissue (paragraph [0270], detectors can respond to the intensity of the optical radiation reflected from the tissue site after absorption and measure an indication of the wearer's physiological parameters including glucose, see paragraph [0250]), the glucose sensor unit comprising:
a printed circuit board (paragraph [0280], Fig. 8F, PCB 816) having at least a first (paragraph [0280], Fig. 8F, detector group 106a and emitter group 104a) and a second sensor array (paragraph [0280], Fig. 8F, detector group 106b and emitter group 104b) coupled therewith, each sensor array including a number of electromagnetic wave emitters and one or more electromagnetic wave receivers (paragraph [0280], Fig. 8F, detector group 106a and emitter group 104a and detector group 106b and emitter group 104b), the one or more electromagnetic wave emitters configured to direct electromagnetic waves into the tissue (paragraph [0270], the emitters can transmit optical radiation of a plurality of wavelengths into a tissue site), in a plurality of cycles, at a predetermined frequency (paragraph [0314], frequency domain pulse rate (FDPR) information obtained from the wavelength), and intensity (paragraph [0306], comparison of the intensity signals of the fourth wavelength and a different wavelength), so as to provoke a characteristic skin response therefrom (paragraph [0252], the emission of light must reach and or interact with tissues, such as the arterial blood in the dermis, wherein the attenuated and reflected light arrives at detectors) and each of the one more electromagnetic wave receivers configured to receive a return of the electromagnetic waves back from the user's tissue and to generate a return signal in response to collecting the returned electromagnetic waves (paragraph [0270], the detectors can respond to the intensity of the optical radiation (which can be reflected from the tissue site) after absorption by pulsatile arterial blood flowing within the tissue site),
collectively the at least first and second electromagnetic wave receivers being configured for collecting the electromagnetic waves back form the body tissue so as to generate the return signal (paragraph [0270], the detectors can respond to the intensity of the optical radiation which can be reflected from the tissue site),
the printed circuit board further comprising an analog to digital converter coupled to the at least first and second electromagnetic wave receivers (paragraph [0297], Fig. 11D, analog-digital converter 1098 on conditioning circuitry 1088 of module PCB 116 receiving analog signals of the emitters 104 and the detectors 106), the analog to digital converter being configured for converting the return signal to digital signal data, and a communications module for transmitting the digital signal data (paragraph [0297], Fig. 11D, analog-digital converter 1098 can output a digital signal based on the analog signals from the optical sensor including the emitters 104, the detectors 106); and
Al-Ali does not specifically disclose the one or more photoemitters configured to illuminate, in one or more cycles, at a predetermined frequency, intensity, and duration of electromagnetic wave emission.
Ferber discloses the one or more photoemitters configured to illuminate, in a plurality cycles, at a predetermined frequency, intensity, and duration of electromagnetic wave emission (paragraph [0100], energy transmitter 204 is configured to generate energy such that energy at different wavelengths (thus, different frequencies as known in the art) is generated sequentially (at a predetermined intensity, see paragraph [0180]) and/or periodically where energy is generated at each particular wavelength until energy at all wavelengths of the set is generated).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the group of emitters as disclosed by Al-Ali with the energy transmitters as taught by Ferber in order that a new generation period is made to start thereby allowing for multiple measurements, (Ferber, paragraph [0100]).
The combination of Al-Ali and Ferber discloses a server system (Fig. 2, remote server 217) for receiving the digital signal data from the multi-sensing detection device (paragraph [0258], Fig. 2, wearable device 10 can establish connection via the computing network 212 to a remote server with a database 217).
The combination of Al-Ali and Ferber does not specifically disclose the server system being configured for performing the one or more of optical, microwave, and near-infrared spectroscopy on the digital signal data so as to produce the characteristic skin response data, and for analyzing the characteristic skin response data so as to generate electromagnetic wave signature data, and further for analyzing the electromagnetic wave signature data so as to thereby determine the concentration of glucose being present in the tissue of the body of the wearer.
Bosua discloses the server system (col. 10, line 63 to col. 11, line 16, Fig. 1, remote server 27) being configured for performing one or more of optical, microwave, and near-infrared spectroscopy on the digital signal data so as to analyze the digital signal data in order to produce the characteristic skin response data (col. 5, lines 1-10, analyte data may be collected using spectroscopic techniques using the microwave frequency range or optical frequencies, and near-infrared wavelengths as emission of wavelengths that are not in the human visible spectrum are not limited to infrared wavelengths, see col. 18, lines 40-67), and further for analyzing the electromagnetic wave signature data so as to thereby determine the concentration of glucose being present in the tissue of the body of the wearer (col. 10, line 63 to col. 11, line 16, Fig. 1, remote server 27 may process (or further process) the signals that controller 19 receives from receiver circuit 17 (see Fig. 1) to detect the analyte(s) 9 and develop the analyte database wherein data analyzer 218 functions to analyze the received analyte data to determine the presence of the analyte(s) and/or the concentration of the analyte(s), see col. 23, line 64 to col. 24, line 4, Fig. 15).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the remote server as disclosed by the combination of Al-Ali and Ferber with the remote server as taught by Bosua to provide remote service to detect analytes (Bosua, col. 10, line 63 to col. 11, line 16).
Consider claim 23, the combination of Al-Ali, Ferber, and Bosua discloses wherein the first sensor array comprises six photoemitters positioned so as to be proximate the first photoreceiver (paragraph [0326], 16B, first group of emitters 404A can include six emitters proximate detector 406a, see paragraph [0327], Fig. 16B).
Consider claim 24, the combination of Al-Ali and Bosua discloses wherein the six photoemitters including a first photoemitter formed of a first light emitting diode configured for emitting light of a wavelength, a second photoemitter formed of a second light emitting diode configured for emitting light of a wavelength, a third photoemitter formed of a third light emitting diode configured for emitting light of a wavelength, a fourth photoemitter formed of a fourth light emitting diode configured for emitting light of a wavelength, a fifth photoemitter formed of a fifth light emitting diode configured for emitting light of a wavelength, and a sixth photoemitter formed of a sixth light emitting diode configured for emitting light of a wavelength (paragraph [0302], Fig. 13B, each of the LED emitters can be configured to emit light of a different wavelength than the other emitters where the first group of emitters 404A can include six emitters, see paragraph [0326]), wherein the first photoreceiver is configured for detecting light of the six photoemitters reflected back from the body’s tissues (paragraph [0270], the detectors can respond to the intensity of the optical radiation provided from the emitters (which can be reflected from the tissue site) after absorption by pulsatile arterial blood flowing within the tissue site).
The combination of Al-Ali and Bosua does not specifically disclose wherein the six photoemitters including a first photoemitter configured for emitting light of a wavelength of about 1050 nm, a second photoemitter configured for emitting light of a wavelength of about 1200 nm, a third photoemitter configured for emitting light of a wavelength of about 1300 nm, a fourth photoemitter configured for emitting light of a wavelength of about 1450 nm, a fifth photoemitter configured for emitting light of a wavelength of about 1550 nm, and a sixth photoemitter configured for emitting light of a wavelength of about 1650 nm.
Ferber discloses wherein the six photoemitters including a first photoemitter configured for emitting light of a wavelength of about 1050 nm, a second photoemitter configured for emitting light of a wavelength of about 1200 nm, a third photoemitter configured for emitting light of a wavelength of about 1300 nm, a fourth photoemitter configured for emitting light of a wavelength of about 1450 nm, a fifth photoemitter configured for emitting light of a wavelength of about 1550 nm, and a sixth photoemitter configured for emitting light of a wavelength of about 1650 nm (paragraph [0091], Ferber discloses energy transmitter 204 may comprise any number of light emission diodes (“LEDs”) and each LED may emit light with a peak wavelength centered around 500 nm to 1800 nm generated sequentially and/or periodically, see paragraph [0100]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the first group of emitters as disclosed by the combination of Al-Ali and Bosua with the energy transmitters as taught by Ferber to emit energy or light at different wavelengths into the body of the user (Ferber, paragraph [0091]).
Consider claim 25, the combination of Al-Ali, Ferber, and Bosua discloses wherein the second array comprises three photoemitters positioned so as to be proximate the second photoreceiver paragraph [0338], Figs. 18A-19C, emitter group 304a, 304b includes three emitters proximate detectors 306a, 306b, 306a/b), the three photoemitters including a seventh photoemitter formed of a seventh light emitting diode configured for emitting light of a red wavelength (paragraph [0304], wavelength having a red color), an eighth photoemitter formed of a eighth light emitting diode configured for emitting light of a green wavelength (paragraph [0303], wavelength having a green color), and a ninth photoemitter formed of a ninth light emitting diode configured for emitting light of an infrared wavelength (paragraph [0305], wavelength can be in the infrared range).
Consider claim 26, the combination of Al-Ali, Ferber, and Bousa discloses wherein the printed circuit board further comprises one or more of an accelerometer (paragraph [0261], device 10 can include an accelerometer) and an SPO2 assembly (paragraph [0250], measurement sensor or module 100 configured to measure oxygen saturation (SpO2)).
Consider claim 27, the combination of Al-Ali, Ferber, and Bosua discloses wherein the printed circuit board (paragraph [0296], Fig. 11C, PCB 116) additionally comprises an ECG module and a plurality of ECG electrodes (paragraph [0298], Fig. 11C, ECG electrodes 124/125), at least one of the plurality of ECG electrodes being a ground ECG electrode (paragraph [0299], ECG electrodes 124 can include a reference electrode), the ground ECG electrode being positioned on opposite sides of the first and second sensor array (paragraph [0299], Figs. 12A, two electrodes 124 located on the sensor or module 100 where one is a reference electrode).
Consider claim 28, the combination of Al-Ali, Ferber, and Bosua discloses wherein the server system comprises an Artificial Intelligence module (Bosua, col. 10, line 63 to col. 11, line 16, Fig. 1, remote server 27, wherein remote server can be performed using artificial intelligence techniques, such as using machine learning techniques, see col. 26, lines 26-38, Fig. 16, 17), and the Artificial Intelligence module is configured for receiving the digital signal data and for performing the one or more of optical, microwave, and near-infrared spectroscopy thereon so as to produce the characteristic skin response results data (Bosua, col. 5, lines 1-10, analyte data may be collected using spectroscopic techniques using the microwave frequency range or optical frequencies, and near-infrared wavelengths as emission of wavelengths that are not in the human visible spectrum are not limited to infrared wavelengths, see col. 18, lines 40-67).
Consider claim 33, the combination of Al-Ali and Ferber discloses a server system (Fig. 2, remote server 217) for receiving the digital signal data from the multi-sensing detection device (paragraph [0258], Fig. 2, wearable device 10 can establish connection via the computing network 212 to a remote server with a database 217).
The combination of Al-Ali and Ferber does not specifically disclose the server system being configured for performing the one or more of optical, microwave, and near-infrared spectroscopy on the digital signal data so as to produce characteristic skin response data, and for analyzing the characteristic skin response data so as to thereby determine a signature of the skin in response to receipt of the spectral array of electromagnetic waves from which electromagnetic wave signature the concentration of the analyte being present in the skin tissue of the body of the wearer may be determined.
Bosua discloses the server system (col. 10, line 63 to col. 11, line 16, Fig. 1, remote server 27) being configured for performing one or more of optical, microwave, and near-infrared spectroscopy on the digital signal data so as to analyze the digital signal data in order to produce the characteristic skin response data (col. 5, lines 1-10, analyte data may be collected using spectroscopic techniques using the microwave frequency range or optical frequencies, and near-infrared wavelengths as emission of wavelengths that are not in the human visible spectrum are not limited to infrared wavelengths, see col. 18, lines 40-67), and for analyzing the characteristic skin response data so as to thereby determine a signature of the skin in response to receipt of the spectral array of electromagnetic waves from which electromagnetic wave signature the concentration of the analyte being present in the skin tissue of the body of the wearer may be determined (col. 10, line 63 to col. 11, line 16, Fig. 1, remote server 27 may process (or further process) the signals that controller 19 receives from receiver circuit 17 (see Fig. 1) to detect the analyte(s) 9 and develop the analyte database wherein data analyzer 218 functions to analyze the received analyte data to determine the presence of the analyte(s) and/or the concentration of the analyte(s), see col. 23, line 64 to col. 24, line 4, Fig. 15).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the remote server as disclosed by the combination of Al-Ali and Ferber with the remote server as taught by Bosua to provide remote service to detect analytes (Bosua, col. 10, line 63 to col. 11, line 16)
Consider claim 36, the combination of Al-Ali, Ferber, and Bosua discloses wherein the server system comprises an Artificial Intelligence module (Bosua, col. 10, line 63 to col. 11, line 16, Fig. 1, remote server 27, wherein remote server can be performed using artificial intelligence techniques, such as using machine learning techniques, see col. 26, lines 26-38, Fig. 16, 17), and the Artificial Intelligence module is configured for receiving the digital signal data and for performing the one or more of optical, microwave, and near-infrared spectroscopy thereon so as to produce the characteristic skin response data (Bosua, col. 5, lines 1-10, analyte data may be collected using spectroscopic techniques using the microwave frequency range or optical frequencies, and near-infrared wavelengths as emission of wavelengths that are not in the human visible spectrum are not limited to infrared wavelengths, see col. 18, lines 40-67), and for analyzing the characteristic skin response data so as to produce the light signature results data (col. 10, line 63 to col. 11, line 16, Fig. 1, remote server 27 may process (or further process) the signals that controller 19 receives from receiver circuit 17 (see Fig. 1) to detect the analyte(s) 9 and develop the analyte database wherein data analyzer 218 functions to analyze the received analyte data to determine the presence of the analyte(s) and/or the concentration of the analyte(s), see col. 23, line 64 to col. 24, line 4, Fig. 15).
Claims 29, 37, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Al-Ali, Ferber, and Bosua in view of Sim et al. (Pub. No.: US 2019/0159705, Applicant’s IDS filed 12/30/2025).
Consider claims 29, 37, the combination of Al-Ali, Ferber, and Bosua discloses wherein the Artificial Intelligence module comprises a Machine Learning module (Bosua, col. 10, line 63 to col. 11, line 16, Fig. 1, remote server 27, wherein remote server can be performed using artificial intelligence techniques, such as using machine learning techniques, see col. 26, lines 26-38, Fig. 16, 17).
The combination of Al-Ali, Ferber, and Bosua does not specifically disclose a Machine Learning module and an Artificial Neural Network (ANN) for analyzing the light signature results data so as to determine the glucose concentration.
Sim discloses a Machine Learning module and an Artificial Neural Network (ANN) for analyzing the light signature results data so as to determine the glucose concentration. (paragraph [0048], performing machine learning using a convolutional neural network (CNN) to predict blood glucose levels in the body).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the Artificial Intelligence module as disclosed by the combination of Al-Ali, Ferber, and Bosua with the Artificial Intelligence module as taught by Sim to apply regression analysis using a convolutional neural network (CNN) for the deep learning (Sim, paragraph [0048]).
Consider claim 38, the combination of Al-Ali, Ferber, Bosua, and Sims discloses wherein the ANN maps the light signature results data to the concentration of glucose (Bosua, col. 10, line 63 to col. 11, line 16, Fig. 1, remote server 27 may process (or further process) the signals that controller 19 receives from receiver circuit 17 (see Fig. 1) to detect the analyte(s) 9 and develop the analyte database wherein data analyzer 218 functions to analyze the received analyte data to determine the presence of the analyte(s) and/or the concentration of the analyte(s), see col. 23, line 64 to col. 24, line 4, Fig. 15).
Claims 30, 34, 39, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Al-Ali, Ferber, and Bosua in view of Haas et al. (Pub. No.: US 2004/0033618, Applicant’s IDS filed 12/30/2025).
Consider claim 30, the combination of Al-Ali, Ferber, and Bosua discloses wherein the ANN maps the characteristic skin response results data to the concentration of glucose (Bosua, col. 25, line 59 to col. 26, line 2, Fig. 16, from established analyte database (see col. 26, lines 26-38, Fig. 16, 17), the analyte data can indicate the presence and concentration of an analyte such as glucose).
The combination of Al-Ali, Ferber, and Bosua does not specifically disclose wherein the mapping comprises comparing an intensity of a number of reflected light wavelengths to the absorption response of the skin so as to determine the characteristic skin response, whereby a level of concentration of glucose can be determined by the characteristic skin response based on a change in a pattern of the skin’s absorption response caused by the presence of glucose within the skin.
Haas discloses wherein the mapping comprises comparing an intensity of a number of reflected light wavelengths to the absorption response of the skin so as to determine the characteristic skin response (paragraph [0099], the absorption at various wavelengths can be determined by comparison to the intensity of the light energy from the energy source), whereby a level of concentration of glucose can be determined by the characteristic skin response based on a change in a pattern of the skin’s absorption response caused by the presence of glucose within the skin (paragraph [0106], measured intensities received by the output sensor in combination with a calibration model are utilized by a multivariate algorithm to predict the glucose concentration in the tissue).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the ANN as disclosed by the combination of Al-Ali, Ferber with the mathematical model function as taught by Haas to provide a multivariate algorithm to predict the glucose concentration in the tissue (Haas, paragraph [0106]).
Consider claim 34, the combination of Al-Ali, Ferber, and Bosua discloses wherein the activation of the photoemitters in accordance with the predetermined wavelength, frequency, intensity, and/or duration results in a pattern of absorption (paragraph [0270], the detectors can respond to the intensity of the optical radiation (which can be reflected from the tissue site) after absorption by pulsatile arterial blood flowing within the tissue site).
The combination of Al-Ali, Ferber, and Bosua does not specifically disclose the server employs the pattern of absorption in determining the light signature from which the concentration of the analyte being present in the tissue of the body of the wearer.
Haas discloses the serverr employs the pattern of absorption in determining the light signature from which the concentration of the analyte being present in the tissue of the body of the wearer (paragraph [0106], measured intensities received by the output sensor in combination with a calibration model are utilized by a multivariate algorithm to predict the glucose concentration in the tissue).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the server as disclosed by the combination of Al-Ali, Ferber, and Bosua with the mathematical model function as taught by Haas to provide a multivariate algorithm to predict the glucose concentration in the tissue (Haas, paragraph [0106]).
Consider claim 39, the combination of Al-Ali, Ferber, and Bosua does not specifically disclose wherein the mapping comprises comparing an intensity of a number of reflected light wavelengths to the absorption response of the skin so as to determine the light signature, whereby a level of concentration of glucose can be determined by the light signature based on a change in a pattern of the skin’s absorption response caused by the presence of glucose within the skin.
Haas discloses wherein the mapping comprises comparing an intensity of a number of reflected light wavelengths to the absorption response of the skin so as to determine the light signature (paragraph [0099], the absorption at various wavelengths can be determined by comparison to the intensity of the light energy from the energy source), whereby a level of concentration of glucose can be determined by the light signature based on a change in a pattern of the skin’s absorption response caused by the presence of glucose within the skin (paragraph [0106], measured intensities received by the output sensor in combination with a calibration model are utilized by a multivariate algorithm to predict the glucose concentration in the tissue).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the ANN as disclosed by the combination of Al-Ali, Ferber with the mathematical model function as taught by Haas to provide a multivariate algorithm to predict the glucose concentration in the tissue (Haas, paragraph [0106]).
Consider claim 40, the combination of Al-Ali, Ferber, Bosua, and Haas discloses wherein the printed circuit board further comprises one or more of an accelerometer (paragraph [0261], device 10 can include an accelerometer), a SPO2 assembly (paragraph [0250], measurement sensor or module 100 configured to measure oxygen saturation (SpO2)), and an ECG module including a plurality of ECG electrodes (paragraph [0298], Fig. 11C, ECG electrodes 124/125).
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Al-Ali, Ferber, Bosua and Haas in view of Miller et al. (Pat. No.: US 11,540,751, Applicant’s IDS filed 12/30/2025).
Consider claim 41, the combination of Al-Ali, Ferber, Bosua and Haas does not specifically disclose wherein the ANN is further configured for determining a health trajectory of the wearer, from which health trajectory a future health state of the wearer is predicted.
Miller discloses wherein the ANN is further configured for determining a health trajectory of the wearer, from which health trajectory a future health state of the wearer is predicted (col. 60, lines 6-41, a predictive model predicting a future data element to include a future glucose level of the subject and a trend of a future set of glucose levels of the subject, wherein the predictive model is generated by cloud-based server 306, see col. 21, lines 14-34, Fig. 3C).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the ANN as disclosed by the combination of Al-Ali, Ferber, Bosua and Haas with the cloud-based server as taught by Miller to identify one or more trends in the non-invasive glucose measurements (Miller, col. 21, lines 14-34).
Claims 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali in view of Ferber.
Consider claim 31, Al-Ali discloses a continuous non-invasive sensor system (paragraph [0250], Figs. 1A-1H, physiological parameter measurement sensor or module 100 performing continuous monitoring, wherein the sensor is non-invasive, see paragraph [0255]) having a multi-sensing detection device (paragraph [0251], Figs., 1E, 1H, plurality of light emitters 104 (such as LEDs) and one or more photodetectors (also referred to as “detectors”) 106), the sensor system for employing diffuse spectrum analysis (paragraph [0287], measurement sensor or module 100 include light diffusing materials in the detector chambers to spread the reflected light to increase the amount of the reflected light reaching the detectors) for determining a characteristic skin response from which a concentration of an analyte being present in a tissue of a body of a wearer of the multi-sensing detection device may be determined (paragraphs [0006], [0098], sensor has at least one emitter that transmits optical radiation of one or more wavelengths into a tissue site and at least one detector that responds to the intensity of the optical radiation to measure an indication of the wearer's physiological parameters including glucose, see paragraph [0250]), the diffuse spectrum analysis comprising one or more of optical, microwave, and near-infrared spectroscopy (paragraph [0270], emitters can transmit optical radiation into a tissue site (near the wrist of the wearer) and the detectors can respond to the intensity of the optical radiation), the system comprising:
a multi-sensing detection device (paragraph [0250], Figs. 1A-1H, physiological parameter measurement sensor or module 100) having an analyte sensor unit (paragraphs [0251], [0006], Figs., 1E, 1H, plurality of light emitters 104 (such as LEDs) for detecting a specific analyte being present within the tissue of the wearer (paragraph [0250], measure an indication of the wearer's physiological parameters including glucose), the multi-sensing detection device comprising:
a housing (paragraph [0251], Figs. 1G, 1H, 3, housing 101) configured for encasing the analyte sensor unit (paragraph [0251], housing 101 can include an opening sized to retain the physiological parameter measurement sensor or module 100),
an analyte sensor unit (paragraphs [0251], [0006], Figs., 1E, 1H, plurality of light emitters 104 (such as LEDs) and one or more photodetectors (also referred to as “detectors”) 106) for provoking and detecting the characteristic skin response of one or more tissues of the body due to a presence of the analyte within the tissue (paragraph [0252], the emission of light must reach and or interact with tissues, such as the arterial blood in the dermis, wherein the attenuated and reflected light arrives at detectors, and the detectors can respond to the intensity of the optical radiation reflected from the tissue site after absorption (see paragraph [0270]) and measure an indication of the wearer's physiological parameters including glucose, see paragraph [0250]), the analyte sensor unit comprising:
a printed circuit board (paragraph [0280], Fig. 8F, PCB 816) having a first (paragraph [0280], Fig. 8F, detector group 106a and emitter group 104a) and a second sensor array (paragraph [0280], Fig. 8F, detector group 106b and emitter group 104b) coupled therewith, each sensor array including a number of photoemitters and one or more photoreceivers (paragraph [0280], Fig. 8F, detector group 106a and emitter group 104a and detector group 106b and emitter group 104b), the one or more photoemitters configured to illuminate, in a plurality of cycles, at a predetermined frequency (paragraph [0314], frequency domain pulse rate (FDPR) information obtained from the wavelength), and intensity (paragraph [0306], comparison of the intensity signals of the fourth wavelength and a different wavelength), the user's tissue (paragraph [0302], Fig. 13B, each of the emitters can be configured to emit light of a different wavelength than the other emitters wherein the emitters can transmit optical radiation of a plurality of wavelengths into a tissue site, see paragraph [0270]) in a manner to produce the characteristic skin response, and each of the one more photoreceivers configured to receive a return of the light reflected back from the user's tissue and to generate a return signal in response to collecting the reflected light (paragraph [0270], the detectors can respond to the intensity of the optical radiation (which can be reflected from the tissue site) after absorption by pulsatile arterial blood flowing within the tissue site),
the first sensor array comprising a first plurality of photoemitters positioned proximate at least a first photoreceiver (paragraph [0280], Fig. 8F, detector group 106a and emitter group 104a), each of the plurality of photoemitters being configured for emitting light into the skin of the wearer (paragraph [0302], Fig. 13B, each of the emitters can be configured to emit light of a different wavelength than the other emitters wherein the emitters can transmit optical radiation of a plurality of wavelengths into a tissue site, see paragraph [0270]), wherein the first photoreceiver is configured for detecting light of the first plurality of photoemitters reflected back from the body's tissues (paragraph [0270], the detectors can respond to the intensity of the optical radiation (which can be reflected from the tissue site) after absorption by pulsatile arterial blood flowing within the tissue site), and
the second array-comprising a second set of a number of additional photoemitters positioned so as to be proximate a second photoreceiver (paragraph [0338], Figs. 18A-19C, emitter group 304a, 304b includes three emitters proximate detectors 306a, 306b, 306a/b), wherein the second photoreceiver is configured for detecting light of the number of additional photoemitters of the second array reflected back from the body's tissues (paragraph [0270], the detectors can respond to the intensity of the optical radiation (which can be reflected from the tissue site) after absorption by pulsatile arterial blood flowing within the tissue site), collectively the photoemitters of the first and second sensory arrays are configured for directing the emitted light of their respective wavelengths into the tissue of the wearer (paragraph [0302], Fig. 13B, each of the emitters can be configured to emit light of a different wavelength than the other emitters wherein the emitters can transmit optical radiation of a plurality of wavelengths into a tissue site, see paragraph [0270]), and the at least first and second photoreceivers are configured for converting the light reflected back form the body tissue so as into the return signal (paragraph [0270], the detectors can respond to the intensity of the optical radiation (which can be reflected from the tissue site) after absorption by pulsatile arterial blood flowing within the tissue site);
the printed circuit board further comprising an analog to digital converter coupled to the at least first and second photoreceivers (paragraph [0297], Fig. 11D, analog-digital converter 1098 on conditioning circuitry 1088 of module PCB 116 receiving analog signals of the emitters 104 and the detectors 106), the analog to digital converter being configured for converting the return signal to digital signal data, and a communications module for transmitting the digital signal data (paragraph [0297], Fig. 11D, analog-digital converter 1098 can output a digital signal based on the analog signals from the optical sensor including the emitters 104, the detectors 106).
Al-Ali does not specifically disclose the one or more photoemitters configured to illuminate, in a plurality of cycles, a predetermined frequency, intensity, and duration of light.
Ferber discloses the one or more photoemitters configured to illuminate, in a plurality of cycles, a predetermined frequency, intensity, and duration of light (paragraph [0100], energy transmitter 204 is configured to generate energy such that energy at different wavelengths (thus, different frequencies as known in the art) is generated sequentially (at a predetermined intensity, see paragraph [0180]) and/or periodically where energy is generated at each particular wavelength until energy at all wavelengths of the set is generated).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the group of emitters as disclosed by Al-Ali with the energy transmitters as taught by Ferber in order that a new generation period is made to start thereby allowing for multiple measurements, (Ferber, paragraph [0100]).
Consider claim 32, Al-Ali discloses a control unit associated with the multi-sensing detection device (paragraph [0301], Fig. 11C, LED driver circuitry 1086 of the module PCB 116), the control unit configured to generate individual and independent activation of each of the photoemitters, whereby each photoemitter of the first and second sensor arrays may be activated individually or collectively (paragraph [0301], Fig. 13A, the LED driver circuitry 1086 can include an emitter switch matrix 1085 configured to drive any of the emitters (or emitter groups) that are selected to be turned on or turn off any of the emitters (or emitter groups) that are selected to be turned off) in one or more of a predetermined wavelength (paragraph [0302], Fig. 13B, each of the emitters can be configured to emit light of a different wavelength than the other emitters), a predetermined frequency (paragraph [0314], frequency domain pulse rate (FDPR) information obtained from the wavelength), and a predetermined intensity (paragraph [0306], comparison of the intensity signals of the fourth wavelength and a different wavelength).
Al-Ali does not specifically disclose whereby each photoemitter of the first and second sensor arrays may include being activated individually or collectively in one or more of a predetermined wavelength, a predetermined frequency, a predetermined intensity, and a predetermined duration.
Ferber discloses whereby each photoemitter of the first and second sensor arrays may include being activated individually or collectively in one or more of a predetermined wavelength, a predetermined frequency, a predetermined intensity, and a predetermined duration (paragraph [0100], energy transmitter 204 is configured to generate energy such that energy at different wavelengths (thus, different frequencies as known in the art) is generated sequentially (at a predetermined intensity, see paragraph [0180]) and/or periodically where energy is generated at each particular wavelength until energy at all wavelengths of the set is generated).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the group of emitters as disclosed by Al-Ali with the energy transmitters as taught by Ferber in order that a new generation period is made to start thereby allowing for multiple measurements, (Ferber, paragraph [0100]).
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.
Claims 22 and 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 15 of copending Application No. 19/412,733 in view of Al-Ali et al. (Pub. No.: US 2023/0058052) and further in view of Ferber et al. (Pub. No.: US 2021/0145334, Applicant’s IDS filed 11/10/2025).
Instant Application
Copending Application No. 19/412,733
22. (Currently Amended) A continuous non-invasive sensor system, the sensor system for employing spectral related characteristic skin response data from which a concentration of glucose being present in a tissue of a body of a wearer of the multi- sensing detection device may be determined, the system comprising:
a multi-sensing detection device being configured for being positioned proximate the skin when the multi-sensing detection device is coupled to the body of the wearer, the multi-sensing detection device having a sensor unit for detecting glucose being present within the wearer's tissue, the multi-sensing detection device comprising:
a housing configured for encasing the sensor unit;
a glucose sensor unit for detecting a skin characteristic response of one or more tissues of the body due to a presence of within the tissue, the sensor unit comprising:
a printed circuit board having a first and a second sensor array coupled therewith, each sensor array including a number of emitters and one or more receivers, each sensor array being arranged on the printed circuit board within in the housing so as to be proximate-the user's skin when the multi-sensing detection device is positioned on the user's body, the one or more emitters being configured to emit, in a plurality of cycles, at a predetermined frequency, intensity, and duration of emission, the tissue of the user's body so as to provoke a skin response therein, and each of the one or more receivers configured to receive a return of the emission back from the user's tissue and to generate a return signal in response to collecting the returned emission,
the first sensor array comprising a first set of emitters positioned so as to be proximate at least a first receiver and being configured for directing emissions out of the housing so as to penetrate a determined depth within the tissue of the user's body, the first set of emitters each configured for being activated individually or collectively, wherein the first receiver is configured for detecting the emissions of the first set of photoemitters returned back from the body's tissues, and
the second sensor array comprising a second set of a number of additional emitters positioned so as to be proximate at least a second receiver, wherein the second receiver is configured for detecting emissions of the number of additional emitters returned back from the body's tissues, collectively the emitters of the first and second sensory arrays being configured for directing their emissions of respective wavelengths into the tissue of the wearer, and the at least first and second receivers being configured for collecting the returned wavelengths back form the body tissue so as to generate the return signal,
the printed circuit board further comprising an analog to digital converter coupled to the at least first and second receivers, the analog to digital converter being configured for converting the return signal to digital signal data, and a communications module for transmitting the digital signal data;
a control unit coupled to the printed circuit board, the control unit configured to generate a pattern for dynamic emitter activation, whereby each emitter of the first and second sensor arrays may be activated individually or collectively in one or more of a predetermined order, a predetermined time interval, a predetermined frequency, and a predetermined intensity; and
a server system for receiving the digital signal data from the multi-sensing detection device, the server system being configured for performing one or more of optical, microwave, and near-infrared spectroscopy so as to analyze the digital signal data in order to produce the characteristic skin response data, and for analyzing the characteristic skin response data so as to thereby determine the concentration of an analyte being present in the tissue of the body of the wearer.
1. A continuous non-invasive sensor system having a multi-sensing detection device, the sensor system for employing spectral related skin response data for determining a concentration of glucose being present in a tissue of a body of a wearer of the multi-sensing detection device, the system comprising:
a multi-sensing detection device being configured for being positioned proximate the wearer’s skin, the multi-sensing detection device having a glucose sensor unit for detecting glucose being present within the wearer’s tissue, the multi-sensing detection device comprising:
a glucose sensor unit for detecting a spectral related skin response of one or more tissues of the body due to an interaction of light with the body tissue in the presence of glucose, the glucose sensor unit comprising:
a printed circuit board having a first and a second sensor array coupled therewith, each sensor array including a number of photoemitters and one or more photoreceivers, each sensor array being arranged on the printed circuit board within the housing so as to be proximate the user’s skin when the multi-sensing detection device is coupled to the user’s body, the one or more photoemitters configured to illuminate, in one or more cycles, at a predetermined frequency and duration of light, the tissue of the user’s body, and each of the one more photoreceivers configured to receive a return of the light reflected back from the user’s tissue and to generate a return signal in response to collecting the reflected light,
the first sensor array comprising a first set of photoemitters configured for being activated individually or collectively and being positioned so as to be proximate at least a first photoreceiver, each individual photoemitter of the first set of photoemitters further being configured for directing light so as to penetrate a first depth within the tissue of the user’s body,
the second sensor array comprising a second set of an additional number of photoemitters configured for being activated individually or collectively and being positioned so as to be proximate at least a second photoreceiver, each photoemitter of the second set of photoemitters further being configured for directing light so as to penetrate a second depth within the tissue of the user’s body, wherein the at least first and second photoreceivers are configured for collecting the light reflected back form the body tissue so as to generate the return signal, and
the printed circuit board further comprising an analog to digital converter coupled to the at least first and second photoreceivers, the analog to digital converter being configured for converting the return signal to digital signal data, and a communications module for transmitting the digital signal data; and a server system for receiving the digital signal data from the multi-sensing detection device,
the server system comprising a first processing module having a first processor for analyzing the digital signal data so as to produce the spectral related skin response data, and a second processor for analyzing the spectral related skin response data so as to thereby determine the concentration of glucose being present in the tissue of the body of the wearer.
31. (Currently Amended) A continuous non-invasive sensor system having a multi-sensing detection device, the sensor system for employing diffuse spectrum analysis for determining a characteristic skin response from which a concentration of an analyte being present in a tissue of a body of a wearer of the multi-sensing detection device may be determined, the diffuse spectrum analysis comprising one or more of optical, microwave, and near-infrared spectroscopy, the system comprising:
a multi-sensing detection device having an analyte sensor unit for detecting a specific analyte being present within the tissue of the wearer, the multi-sensing detection device comprising:
a housing configured for encasing the analyte sensor unit;
an analyte sensor unit for provoking and detecting the characteristic skin response of one or more tissues of the body due to a presence of the analyte within the tissue, the analyte sensor unit comprising:
a printed circuit board having a first and a second sensor array coupled therewith, each sensor array including a number of electromagnetic wave emitters and one or more photo electromagnetic wave receivers, the one or more electromagnetic wave emitters configured to emit, in a plurality of cycles, at a predetermined frequency, intensity, and duration of emission, the user's tissue in a manner to produce the characteristic skin response, and each of the one more electromagnetic wave receivers configured to receive a return of the electromagnetic waves back from the user's tissue and to generate a return signal in response to collecting the returned electromagnetic waves back from the tissue,
the first sensor array comprising a first plurality of electromagnetic wave emitters positioned proximate at least a first electromagnetic wave receiver, each of the plurality of electromagnetic wave emitters being configured for emitting electromagnetic waves into the skin of the wearer, wherein the first electromagnetic wave receiver is configured for detecting electromagnetic waves of the first plurality of electromagnetic wave emitters returned back from the body's tissues, and
the second array-comprising a second set of a number of additional electromagnetic wave emitters positioned so as to be proximate a second electromagnetic wave receivers, wherein the second electromagnetic wave receiver is configured for detecting electromagnetic waves of the number of additional electromagnetic wave emitters of the second array returned back from the body's tissues, collectively the electromagnetic wave emitters of the first and second sensory arrays are configured for directing the emitted electromagnetic waves of their respective wavelengths into the tissue of the wearer, and the at least first and second electromagnetic wave receivers are configured for converting the electromagnetic waves returned back form the body tissue so as into the return signal;
the printed circuit board further comprising an analog to digital converter coupled to the at least first and second electromagnetic wave receivers, the analog to digital converter being configured for converting the return signal to digital signal data, and a communications module for transmitting the digital signal data.
15. A continuous non-invasive sensor system having a multi-sensing detection device, the sensor system for employing skin response data for determining a concentration of glucose being present in a tissue of a body of a wearer of the multi-sensing detection device, the system comprising:
a multi-sensing detection device being configured for being positioned proximate the wearer’s skin, the multi-sensing detection device having a glucose sensor unit for detecting glucose being present within the wearer’s tissue, the multi-sensing detection device comprising:
a glucose sensor unit being positioned within the housing and being configured for detecting a skin response of one or more tissues of the body due to an interaction of light with the body tissue in the presence of glucose, the glucose sensor unit comprising:
a printed circuit board having a first and a second sensor array coupled therewith, each sensor array including a number of photoemitters and one or more photoreceivers, each sensor array being arranged on the printed circuit board within the housing so as to be proximate the user’s skin when the multi-sensing detection device is coupled to the user’s body, the one or more photoemitters configured to illuminate the tissue of the user’s body, and each of the one more photoreceivers configured to receive a return of the light reflected back from the user’s tissue and to generate a return signal in response to collecting the reflected light,
the first sensor array comprising a first set of photoemitters configured for being activated individually or collectively and being positioned so as to be proximate at least a first photoreceiver,
the second sensor array comprising a second set of photoemitters configured for being activated individually or collectively and being positioned so as to be proximate at least a second photoreceiver, wherein the at least the first and second photoreceivers are configured for collecting the light reflected back form the body tissue so as to generate the return signal, and
the printed circuit board further comprising an analog to digital converter coupled to the at least first and second photoreceivers, the analog to digital converter being configured for converting the return signal to digital signal data, and a communications module for transmitting the digital signal data; and a server for receiving the digital signal data from the multi-sensing detection device,
the server system comprising a first processing module having a first processor for analyzing the digital signal data so as to produce the skin response data, and a second processor for analyzing the skin response data so as to thereby determine the concentration of glucose being present in the tissue of the body of the wearer.
The copending application teaches all the limitations of claims 22 and 31 except for the highlighted portions identified above.
Regarding claim 22, Al-Ali discloses a housing (paragraph [0251], Figs. 1G, 1H, 3, housing 101) configured for encasing the sensor unit (paragraph [0251], housing 101 can include an opening sized to retain the physiological parameter measurement sensor or module 100),
a control unit coupled to the printed circuit board (paragraph [0301], Fig. 11C, LED driver circuitry 1086 of the module PCB 116), the control unit configured to generate a pattern for dynamic emitter activation, whereby each emitter of the first and second sensor arrays may be activated individually or collectively in one or more of a predetermined order (paragraph [0301], Fig. 13A, the LED driver circuitry 1086 can include an emitter switch matrix 1085 configured to drive any of the emitters (or emitter groups) that are selected to be turned on or turn off any of the emitters (or emitter groups) that are selected to be turned off), a predetermined frequency (paragraph [0314], frequency domain pulse rate (FDPR) information obtained from the wavelength), and a predetermined intensity (paragraph [0306], comparison of the intensity signals of the fourth wavelength and a different wavelength).
Al-Ali does not specifically disclose whereby each emitter of the first and second sensor arrays may include being activated individually or collectively in one or more of a predetermined order, a predetermined frequency, a predetermined intensity, and a predetermined time interval.
Ferber discloses whereby each emitter of the first and second sensor arrays may include being activated individually or collectively in one or more of a predetermined order, a predetermined frequency, a predetermined intensity, and a predetermined time interval (paragraph [0100], energy transmitter 204 is configured to generate energy such that energy at different wavelengths (thus, different frequencies as known in the art) is generated sequentially (at a predetermined intensity, see paragraph [0180]) and/or periodically where energy is generated at each particular wavelength until energy at all wavelengths of the set is generated).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the group of emitters as disclosed by Al-Ali with the energy transmitters as taught by Ferber in order that a new generation period is made to start thereby allowing for multiple measurements, (Ferber, paragraph [0100]).
Regarding claim 31, Al-Ali discloses a housing (paragraph [0251], Figs. 1G, 1H, 3, housing 101) configured for encasing the analyte sensor unit (paragraph [0251], housing 101 can include an opening sized to retain the physiological parameter measurement sensor or module 100),
each of the plurality of photoemitters being configured for emitting light into the skin of the wearer (paragraph [0302], Fig. 13B, each of the emitters can be configured to emit light of a different wavelength than the other emitters wherein the emitters can transmit optical radiation of a plurality of wavelengths into a tissue site, see paragraph [0270]), wherein the first photoreceiver is configured for detecting light of the first plurality of photoemitters reflected back from the body's tissues (paragraph [0270], the detectors can respond to the intensity of the optical radiation (which can be reflected from the tissue site) after absorption by pulsatile arterial blood flowing within the tissue site), and
collectively the photoemitters of the first and second sensory arrays are configured for directing the emitted light of their respective wavelengths into the tissue of the wearer (paragraph [0302], Fig. 13B, each of the emitters can be configured to emit light of a different wavelength than the other emitters wherein the emitters can transmit optical radiation of a plurality of wavelengths into a tissue site, see paragraph [0270]), and the at least first and second photoreceivers are configured for converting the light reflected back form the body tissue so as into the return signal (paragraph [0270], the detectors can respond to the intensity of the optical radiation (which can be reflected from the tissue site) after absorption by pulsatile arterial blood flowing within the tissue site).
This is a provisional nonstatutory double patenting rejection.
Claims 22-24, 27,29, and 31-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22-24, 30, 32, and 37-39 of copending Application No. 19/270,340 in view of Al-Ali et al. (Pub. No.: US 2023/0058052, Applicant’s IDS filed 12/30/2025).
Instant Application
Copending Application No.: 19/270,340
22. A continuous non-invasive sensor system having a multi-sensing detection device, the sensor system for employing spectral related characteristic skin response data from which a concentration of glucose being present in a tissue of a body of a wearer of the multi-sensing detection device may be determined, the system comprising:
a multi-sensing detection device being configured for being positioned proximate the skin when the multi-sensing detection device is coupled to the body of the wearer, the multi-sensing detection device having a glucose sensor unit for detecting glucose being present within the wearer's tissue, the multi-sensing detection device comprising:
a housing configured for encasing the glucose sensor unit;
a glucose sensor unit for detecting a skin characteristic response of one or more tissues of the body due to a presence of glucose within the tissue, the glucose sensor unit comprising:
a printed circuit board having a first and a second sensor array coupled therewith, each sensor array including a number of photoemitters and one or more photoreceivers, each sensor array being arranged on the printed circuit board within in the housing so as to be proximate-the user's skin when the multi-sensing detection device is positioned on the user's body, the one or more photoemitters being configured to illuminate, in a plurality of cycles, at a predetermined frequency, intensity, and duration of light, the tissue of the user's body, and each of the one more photoreceivers configured to receive a return of the light reflected back from the user's tissue and to generate a return signal in response to collecting the reflected light, the first sensor array comprising a first set of photoemitters positioned so as to be proximate at least a first photoreceiver and being configured for directing light out of the housing so as to penetrate a determined depth within the tissue of the user's body, the first set of photoemitters each configured for being activated individually or collectively, wherein the first photoreceiver is configured for detecting light of the first set of photoemitters reflected back from the body's tissues, and the second sensor array comprising a second set of a number of additional photoemitters positioned so as to be proximate at least a second photoreceiver, wherein the second photoreceiver is configured for detecting light of the number of additional photoemitters reflected back from the body's tissues, collectively the photoemitters of the first and second sensory arrays being configured for directing the emitted light of their respective wavelengths into the tissue of the wearer, and the at least first and second photoreceivers being configured for collecting the light reflected back form the body tissue so as to generate the return signal, the printed circuit board further comprising an analog to digital converter coupled to the at least first and second photoreceivers, the analog to digital converter being configured for converting the return signal to digital signal data, and a communications module for transmitting the digital signal data; a control unit coupled to the printed circuit board, the control unit configured to generate a pattern for dynamic photoemitter activation, whereby each photoemitter of the first and second sensor arrays may be activated individually or collectively in one or more of a predetermined order, a predetermined time interval, a predetermined frequency, and a predetermined intensity; and a server system for receiving the digital signal data from the multi-sensing detection device, the server system comprising a first processing module having a first processor for analyzing the digital signal data so as to produce the characteristic skin response data data, and a second processor for analyzing the characteristic skin response data so as to thereby determine the concentration of glucose being present in the tissue of the body of the wearer.
22. A continuous non-invasive sensor system having a multi-sensing detection device,
the sensor system for employing spectral related characteristic skin response data for determining a light signature from which a concentration of glucose being present in a tissue of a body of a wearer of the multi-sensing detection device may be determined, the system comprising:
a multi-sensing detection device being configured for being positioned proximate the skin when the multi-sensing detection device is coupled to the body of the wearer, the multi-sensing detection device having a glucose sensor unit for detecting glucose being present within the wearer’s tissue, the multi-sensing detection device comprising:
a housing configured for encasing the glucose sensor unit, the housing having a top cover and a bottom cover, wherein at least one of the top or bottom covers includes a transparent portion therein;
a glucose sensor unit for detecting a skin characteristic response of one or more tissues of the body due to a presence of glucose within the tissue, the glucose sensor unit comprising:
a printed circuit board having a first and a second sensor array coupled therewith, each sensor array including a number of photoemitters and one or more photoreceivers, each sensor array being arranged on the printed circuit board within in the housing so as to be proximate the transparent portion in contact with the user’s skin when the multi-sensing detection device is coupled to the user’s body, the one or more photoemitters configured to illuminate, in one or more cycles, at a predetermined frequency and duration of light, the tissue of the user’s body, and each of the one more photoreceivers configured to receive a return of the light reflected back from the user’s tissue and to generate a return signal in response to collecting the reflected light,
the first sensor array comprising a first set of photoemitters positioned so as to be proximate at least a first photoreceiver and being configured for directing light out of the transparent portion so as to penetrate a determined depth within the tissue of the user’s body, the first set of photoemitters each being formed of one or more light emitting diodes configured for emitting light in a cycle of predetermined wavelengths for a predetermined pulse duration where each of the LEDs is activated individually, wherein the first photoreceiver is configured for detecting light of the first set of photoemitters reflected back from the body’s tissues, and the second sensor array comprising a second set of a number of additional photoemitters positioned so as to be proximate at least a second photoreceiver, wherein the second photoreceiver is configured for detecting light of the number of additional photoemitters reflected back from the body’s tissues, collectively the light emitting diodes of the first and second sensory arrays being configured for directing the emitted light of their respective wavelengths into the tissue of the wearer, and the at least first and second photoreceivers being configured for collecting the light reflected back form the body tissue so as to generate the return signal, the printed circuit board further comprising an analog to digital converter coupled to the at least first and second photoreceivers, the analog to digital converter being configured for converting the return signal to digital signal data, and a communications module for transmitting the digital signal data; and a server system for receiving the digital signal data from the multi-sensing detection device, the server system comprising a first processing module having a first processor for analyzing the digital signal data so as to produce light signature data, and a second processor for analyzing the light signature data so as to thereby determine the concentration of glucose being present in the tissue of the body of the wearer.
23. The continuous non-invasive sensor system in accordance with claim 22, wherein the first sensor array comprises six photoemitters positioned so as to be proximate the first photoreceiver.
23. The continuous non-invasive sensor system in accordance with claim 22, wherein the first sensor array comprises six photoemitters positioned so as to be proximate the first photoreceiver.
24. The continuous non-invasive sensor system in accordance with claim 23, wherein the six photoemitters including a first photoemitter formed of a first light emitting diode configured for emitting light of a wavelength of about 1050 nm, a second photoemitter formed of a second light emitting diode configured for emitting light of a wavelength of about 1200 nm, a third photoemitter formed of a third light emitting diode configured for emitting light of a wavelength of about 1300 nm, a fourth photoemitter formed of a fourth light emitting diode configured for emitting light of a wavelength of about 1450 nm, a fifth photoemitter formed of a fifth light emitting diode configured for emitting light of a wavelength of about 1550 nm, and a sixth photoemitter formed of a sixth light emitting diode configured for emitting light of a wavelength of about 1650 nm, wherein the first photoreceiver is configured for detecting light of the six photoemitters reflected back from the body's tissues.
24. The continuous non-invasive sensor system in accordance with claim 23, wherein the six photoemitters including a first photoemitter formed of a first light emitting diode configured for emitting light of a wavelength of about 1050 nm, a second photoemitter formed of a second light emitting diode configured for emitting light of a wavelength of about 1200 nm, a third photoemitter formed of a third light emitting diode configured for emitting light of a wavelength of about 1300 nm, a fourth photoemitter formed of a fourth light emitting diode configured for emitting light of a wavelength of about 1450 nm, a fifth photoemitter formed of a fifth light emitting diode configured for emitting light of a wavelength of about 1550 nm, and a sixth photoemitter formed of a sixth light emitting diode configured for emitting light of a wavelength of about 1650 nm, wherein the first photoreceiver is configured for detecting light of the six photoemitters reflected back from the body’s tissues
27. The continuous non-invasive sensor system in accordance with claim 26, wherein the printed circuit board additionally comprises an ECG module and a plurality of ECG electrodes, at least one of the plurality of ECG electrodes being a ground ECG electrode, the ground ECG electrode being positioned on opposite sides of the first and second sensor array.
30. The continuous non-invasive sensor system in accordance with claim 29, wherein the printed circuit board additionally comprises an ECG module and a plurality of ECG electrodes, at least one of the plurality of ECG electrodes being a ground ECG electrode, the ground ECG electrode being positioned on opposite sides of the first and second sensor array.
29. The continuous non-invasive sensor system in accordance with claim 28, wherein the Artificial Intelligence module comprises a Machine Learning module and an Artificial Neural Network (ANN).
32. The continuous non-invasive sensor system in accordance with claim 31, wherein the Artificial Intelligence module comprises a Machine Learning module and an Artificial Neural Network (ANN).
31. A continuous non-invasive sensor system having a multi-sensing detection device, the sensor system for employing diffuse reflectance spectrum analysis for determining a characteristic skin response from which a concentration of an analyte being present in a tissue of a body of a wearer of the multi-sensing detection device may be determined, the system comprising: a multi-sensing detection device having an analyte sensor unit for detecting a specific analyte being present within the tissue of the wearer, the multi-sensing detection device comprising: a housing configured for encasing the analyte sensor unit,; an analyte sensor unit for detecting the characteristic skin response of one or more tissues of the body due to a presence of the analyte within the tissue, the analyte sensor unit comprising: a printed circuit board having a first and a second sensor array coupled therewith, each sensor array including a number of photoemitters and one or more photoreceivers, the one or more photoemitters configured to illuminate, in a plurality of cycles, at a predetermined frequency, intensity, and/or duration of light, the user's tissue in a manner to produce the characteristic skin response, and each of the one more photoreceivers configured to receive a return of the light reflected back from the user's tissue and to generate a return signal in response to collecting the reflected light, the first sensor array comprising a first plurality of photoemitters positioned proximate at least a first photoreceiver, each of the plurality of photoemitters being configured for emitting light into the skin of the wearer, wherein the first photoreceiver is configured for detecting light of the first plurality of photoemitters reflected back from the body's tissues, and the second array-comprising a second set of a number of additional photoemitters positioned so as to be proximate a second photoreceiver, wherein the second photoreceiver is configured for detecting light of the number of additional photoemitters of the second array reflected back from the body's tissues, collectively the photoemitters of the first and second sensory arrays are configured for directing the emitted light of their respective wavelengths into the tissue of the wearer, and the at least first and second photoreceivers are configured for converting the light reflected back form the body tissue so as into the return signal; the printed circuit board further comprising an analog to digital converter coupled to the at least first and second photoreceivers, the analog to digital converter being configured for converting the return signal to digital signal data, and a communications module for transmitting the digital signal data.
37. A continuous non-invasive sensor system having a multi-sensing detection device, the sensor system for employing diffuse reflectance spectrum analysis for determining a characteristic skin response from which a concentration of an analyte being present in a tissue of a body of a wearer of the multi-sensing detection device may be determined, the system comprising: a multi-sensing detection device having an analyte sensor unit for detecting a specific analyte being present within the tissue of the wearer, the multi-sensing detection device comprising: a housing configured for encasing the analyte sensor unit, the housing having a top cover and a bottom cover, the bottom cover being configured to be held against the skin of the wearer; an analyte sensor unit for detecting a characteristic skin response of one or more tissues of the body due to a presence of the analyte within the tissue, the analyte sensor unit comprising:
a printed circuit board having a first and a second sensor array coupled therewith, each sensor array including a number of photoemitters and one or more photoreceivers, the one or more photoemitters configured to illuminate, in a plurality of cycles, at a predetermined frequency and duration of light, the user’s tissue, and each of the one more photoreceivers configured to receive a return of the light reflected back from the user’s tissue and to generate a return signal in response to collecting the reflected light, the first sensor array comprising a first plurality of photoemitters positioned proximate at least a first photoreceiver, each of the plurality of photoemitters being configured for emitting light of a predetermined wavelength and for a predetermined duration of time in one or more cycles so as to generate a spectral related characteristic skin response in the tissues of the wearer, wherein the first photoreceiver is configured for detecting light of the first plurality of photoemitters reflected back from the body’s tissues, and the second array comprises three photoemitters positioned so as to be proximate a second photoreceiver, the three photoemitters including a first photoemitter formed of a first light emitting diode configured for emitting light of a first wavelength, a second photoemitter formed of a second light emitting diode configured for emitting light of a second wavelength, and a third photoemitter formed of a third light emitting diode configured for emitting light of a third wavelength, wherein the second photoreceiver is configured for detecting light of the three photoemitters of the second array reflected back from the body’s tissues, collectively the photoemitters of the first and second sensory arrays are configured for directing the emitted light of their respective wavelengths into the tissue of the wearer, and the at least first and second photoreceivers are configured for converting the light reflected back form the body tissue so as into the return signal; the printed circuit board further comprising an analog to digital converter coupled to the at least first and second photoreceivers, the analog to digital converter being configured for converting the return signal to digital signal data, and a communications module for transmitting the digital signal data; and
a control unit coupled to the printed circuit board, the control unit configured to generate individual and independent activation of each of the photoemitters, whereby each photoemitter of the first and second sensor arrays may be activated individually or collectively in one or more of a predetermined wavelength, a predetermined frequency, a predetermined intensity, and a predetermined duration.
33. The continuous non-invasive sensor system in accordance with claim 32, further comprising a server system for receiving the digital signal data from the multi-sensing detection device, the server system comprising a first processing module having a first processor for analyzing the digital signal data so as to produce characteristic skin response data, and a second processor for analyzing the characteristic skin response data so as to thereby determine a light signature of the skin in response to receipt of the spectral array of light waves from which light signature the concentration of the analyte being present in the skin tissue of the body of the wearer may be determined.
38. The continuous non-invasive sensor system in accordance with claim 37, further comprising a server system for receiving the digital signal data from the multi-sensing detection device, the server system comprising a first processing module having a first processor for analyzing the digital signal data so as to produce spectral array data, and a second processor for analyzing the spectral array data so as to thereby determine a light signature of the skin in response to receipt of the spectral array of light waves from which light signature the concentration of the analyte being present in the skin tissue of the body of the wearer.
34. The continuous non-invasive sensor system in accordance with claim 33, wherein the activation of the photoemitters in accordance with the predetermined wavelength, frequency, intensity, and/or duration results in a pattern of absorption, and the second processor employs the pattern of absorption in determining the light signature from which the concentration of the analyte being present in the tissue of the body of the wearer.
39. The continuous non-invasive sensor system in accordance with claim 38, wherein the activation of the photoemitters in accordance with the predetermined wavelength, frequency, intensity, and/or duration results in a pattern of absorption, and the second processor employs the pattern of absorption in determining the light signature from which the concentration of the analyte being present in the tissue of the body of the wearer.
The copending application teaches all the limitations of claim 22 except for the highlighted portions identified above.
Al-Ali discloses a control unit coupled to the printed circuit board (paragraph [0301], Fig. 11C, LED driver circuitry 1086 of the module PCB 116), the control unit configured to generate a pattern for dynamic photoemitter activation, whereby each photoemitter of the first and second sensor arrays may be activated individually or collectively in one or more of a predetermined order (paragraph [0301], Fig. 13A, the LED driver circuitry 1086 can include an emitter switch matrix 1085 configured to drive any of the emitters (or emitter groups) that are selected to be turned on or turn off any of the emitters (or emitter groups) that are selected to be turned off), a predetermined frequency (paragraph [0314], frequency domain pulse rate (FDPR) information obtained from the wavelength), and a predetermined intensity (paragraph [0306], comparison of the intensity signals of the fourth wavelength and a different wavelength).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the printed circuit board as disclosed by copending application with the printed circuit board as taught by Al-Ali to drive any of the emitters (or emitter groups) that are selected to be turned on or turn off any of the emitters (or emitter groups) that are selected to be turned off (Al-Ali, paragraph [0301]).
This is a provisional nonstatutory double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kwon et al. (Pub. No.: US 2016/0206251) discloses a skin surface pulse wave is a signal obtained by detecting a change in reflected light detected by the optical detector due to vibrations on a skin surface occurring according to a change in a blood volume in a blood vessel.
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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/Gerald Johnson/
Primary Examiner, Art Unit 3797
