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 12/31/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Terminal Disclaimer
The terminal disclaimer filed on 03/23/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on Application Number 19/292,790 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant's arguments filed 03/23/2026 have been fully considered but they are not persuasive.
In response to applicant’s argument that “…the recited claim elements within the body of the present claims need not depend from the preamble, according to the MPEP these claims are definite as written,” the examiner notes, MPEP 2111.02 states that "If the claim preamble, when read in the context of the entire claim, recites limitations of the claim, or, if the claim preamble is ‘necessary to give life, meaning, and vitality’ to the claim, then the claim preamble should be construed as if in the balance of the claim." Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165-66 (Fed. Cir. 1999). MPEP 2111.02 further states that any terminology in the preamble that limits the structure of the claimed invention must be treated as a claim limitation. See, e.g., Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257, 9 USPQ2d 1962, 1966 (Fed. Cir. 1989). In this case, claim 22 is directed to a continuous non-invasive sensor system having a multi-sensing detection device. While the claim is not directly limited to the multi-sensing detection device, the multi-sensing detection device structure recited in the preamble does limit the structure of the continuous non-invasive sensor system.
Accordingly, the 35 U.S.C. 112(b) rejection is maintained.
Throughout applicant’s remarks filed 03/23/2026, applicant provides example teachings of primary reference Al-Ali that are optional teachings that were not used in the rejection of the claims. For example, in applicant’s remarks on pages 19 and 20 applicant argues, at paragraph [0265], that Al-Ali teaches an invasive finger-prick glucose monitoring device and thus actually teaches away from a glucose monitoring device. Contrary to applicant’s assertions, paragraph [0265] was not cited in the rejection because it clearly teaches that “Optionally, the wearable device 10 can communicate with glucose monitors, which can be invasive or minimally invasive such as finger prick type of glucose monitors, or a continuous noninvasive glucose monitor” and is not applicable to applicant’s claims. As noted in the previous rejection, Al-Ali teaches, at paragraph [0250], “the wearable device 10 can be a watch, which can include a physiological parameter measurement sensor or module 100 configured to measure an indication of the wearer's physiological parameters, which can include glucose...The sensor or module 100 can perform…continuous monitoring of the measured parameters”; thus, a continuous non-invasive glucose monitor device. Therefore, applicant’s remaining arguments throughout the remarks regarding the lack of teaching of a continuous non-invasive glucose monitor device are moot.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Al-Ali discloses some of the features but not all of an emitter illuminating, in one or more cycles, at a predetermined frequency and duration of light. However, Ferber discloses all these features in the operation of the emitters in order that a new generation period is made to start thereby allowing for multiple measurements (see paragraph [0100]).
In response to applicant's argument that “the present disclosure provides a sensor which allows for measuring pulse oximetry at sparse capillary bed locations”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to applicant’s statement that “through the research and inventiveness of the inventors hereof, it has been determined that former attempts to derive a concentration of a chemical agent within the blood and tissues through the direct spectroscopic detection of that agent, e.g., such as by solely using a PPG sensor, are believed to be doomed to failure”, as discussed, for example, in rejection of claim 37 below with respect to 35 USC 112(a), the applicant has not disclosed and/or shown via drawings in the specification the “research and inventiveness” to using a PPG sensor in combination with a microwave sensor with the structure as amended in the claims. The only structure explicitly taught is a PPG sensor via paragraph [0025], Fig. 1, paragraph [0031], Figs. 1 and 3, paragraph [0033], Fig. 4, and paragraph [0038], Fig. 5 where each of these areas discuss the implementation of light emitting diodes and photodiodes known in the art to be associated with PPG technology, respectively, and are used in both the first and second sensor assemblies. According to applicant’s specification at paragraph [0020], “some methods can include…microwave spectroscopy”; however, as known in the art, microwave spectroscopy operates in a non-visible spectrum typically requiring antennas for transmitting and receiving – none of which or otherwise is discussed throughout applicant’s specification to suggest the structure as claimed.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Accordingly, the examiner maintains the rejection.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first sensor assembly performs microwave spectroscopy while the second sensor assembly comprises a PPG sensor assembly (or similarly, the first sensor assembly comprises a PPG sensor assembly while the second sensor assembly performs microwave spectroscopy) and additionally, the second sensor assembly comprises three electromagnetic wave emitters positioned so as to be proximate the first electromagnetic wave receiver must be shown or the feature canceled from the claims. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 22, 23, 28, 37, 41, 42, 44, 52, and 53 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 23, there is no disclosure to the second sensor assembly comprising electromagnetic wave emitters positioned so as to be proximate the first electromagnetic wave receiver (associated with the first sensor assembly). According to claim 22 and as set forth in applicant’s specification at paragraph [0025], Fig. 1, the first electromagnetic wave receiver is configured for detecting electromagnetic waves of the first set of electromagnetic wave emitters as they are proximate one another on the same sensor assembly.
Regarding claims 37 and 41, while at paragraph [0020] (and only at paragraph [0020], emphasis added) applicant teaches “some methods can include…microwave spectroscopy”, there is no further discussion including figures to the implementation as claimed. Specifically, there is no teaching or related figures wherein the first sensor assembly performs microwave spectroscopy while the second sensor assembly comprises a PPG sensor assembly as further defined by dependent claim 41. In particular, one of ordinary skill in the art understands that microwave spectroscopy operates in a non-visible spectrum typically requiring antennas for transmitting and receiving – none of which or otherwise is discussed at paragraph [0025], Fig. 1, paragraph [0031], Figs. 1 and 3, paragraph [0033], Fig. 4, and paragraph [0038], Fig. 5 where each of these areas discuss the implementation of light emitting diodes and photodiodes associated with PPG technology, respectively.
Regarding claims 22, 28, and 52, the combination these claims form the same structure as provided in the combination of claims 37 and 41 as discussed above; therefore, it is rejected for same reasons.
Regarding claims 42, 44, and 53, the combination these claims form the same structure as provided in the combination of claims 37 and 41 as discussed above; therefore, it is rejected for same reasons.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 22, 34, 35, 37, 42, 49 and 50 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 22, 37 and 42 recite the limitation "a multi-sensing detection device” in lines 1 and 5, respectively, as being comprised by a system. It is unclear if the second instance of the multi-sensing detection device is different from or the same as the first instance.
Claim 22 recites the limitation "a glucose sensor unit” in lines 7 and 12, respectively, as being comprised by a multi-sensing detection device. It is unclear if the second instance of the glucose sensor unit is different from or the same as the first instance.
Claim 42 recites the limitation "a glucose sensor unit” in lines 7 and 10, respectively, as being comprised by a multi-sensing detection device. It is unclear if the second instance of the glucose sensor unit is different from or the same as the first instance.
Claim 37 recites the limitation "an analyte sensor unit” in lines 5 and 10, respectively, as being comprised by a multi-sensing detection device. It is unclear if the second instance of the analyte sensor unit is different from or the same as the first instance.
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, 23, 26, 28-31, 33, 42-46 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali et al. (Pub. No.: US 2023/0058052) in view of Ferber et al. (Pub. No.: US 2021/0145334, Applicant’s IDS filed 10/15/2025) and further in view of Mehnert et al. (Pat. No.: US 11,647,854).
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]) having a multi-sensing detection device (paragraph [0250], Figs. 1A-1H, physiological parameter measurement sensor or module 100), the sensor system for employing spectral related characteristic skin response data for determining an electromagnetic 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 (paragraph [0006], 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), the housing having a top cover (paragraph [0266], Figs. 1F, 3, display screen 12) and a bottom cover (paragraph [0251], Fig. 1F, skin-interfacing light transmissive cover 102), that when coupled together form a cavity there between within which cavity the sensor unit may be retained therein (paragraph [0251], as shown in FIGS. 1F and 1H, the physiological parameter measurement sensor or module 100 can include a skin-interfacing light transmissive cover 102 that encloses a plurality of light emitters 104 (such as LEDs) and one or more photodetectors (also referred to as “detectors”) 106);
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 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 a first (paragraph [0280], Fig. 8F, detector group 106a and emitter group 104a) and a second sensor assembly (paragraph [0280], Fig. 8F, detector group 106b and emitter group 104b) coupled therewith, each sensor assembly 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 number of electromagnetic wave emitters configured to emit, in one or more 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 than the other emitters wherein the emitters can transmit optical radiation of a plurality of wavelengths into a tissue site, see paragraph [0270]), 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),
the first sensor assembly comprising a first set of electromagnetic wave emitters positioned so as to be proximate at least a first electromagnetic wave receivers (paragraph [0280], Fig. 8F, detector group 106a and emitter group 104a) and being configured for directing electromagnetic waves out of the housing so as to penetrate a first 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 electromagnetic wave emitters each being configured for emitting electromagnetic waves in a cycle of predetermined wavelengths where each of the emitters is activated individually (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), and the first electromagnetic wave receivers is configured for detecting electromagnetic waves of the first set of electromagnetic wave emitters received 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 assembly comprising a second set of additional electromagnetic wave emitters positioned so as to be proximate at least a second electromagnetic wave receiver (paragraph [0280], Fig. 8F, detector group 106b and emitter group 104b) and being configured for directing electromagnetic waves out of the housing so as to penetrate a second 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]), wherein the second electromagnetic wave receiver is configured for detecting electromagnetic waves of the second set of electromagnetic wave 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 electromagnetic wave emitters of the first and second sensor assemblies being configured for directing the emitted electromagnetic waves 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 first and second electromagnetic wave receivers being configured for collecting the electromagnetic waves returned 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 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);
Al-Ali does not specifically disclose the one or more electromagnetic wave emitters configured to illuminate, in one or more cycles, at a predetermined frequency and duration of light.
Ferber discloses the one or more electromagnetic wave emitters configured to illuminate, in one or more cycles, at a predetermined frequency and duration of light (paragraph [0100], energy transmitter 204 is configured to generate energy such that energy at different wavelengths is generated sequentially 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 analyzing the digital signal data so as to produce electromagnetic signature data, and for analyzing the electromagnetic signature data so as to thereby determine the concentration of glucose being present in the tissue of the body of the wearer.
Mehnert discloses the server system (col. 20, lines 12-39, Fig. 5, server 130) comprising analyzing the digital signal data so as to produce light signature data (col. 20, lines 12-39, Fig. 5, server 130 may analyze and/or process the sensor data), and analyzing the electromagnetic signature data so as to thereby determine the concentration of glucose being present in the tissue of the body of the wearer (col. 20, lines 12-39, Fig. 5, server 130 may determine a blood sugar level measurement).
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 server as taught by Mehnert to determine how the data impacts or otherwise affects certain limits and/or goals (Mehnert, col. 20, lines 12-39).
Consider claim 42, 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 employing characteristic skin response data for determining an electromagnetic radiation signature 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 (paragraph [0006], 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 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 detecting an analyte 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 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 detecting a characteristic skin response of one or more tissues of the body due to a presence of the analyte 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 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 assembly (paragraph [0280], Fig. 8F, detector group 106b and emitter group 104b) coupled therewith, each sensor assembly 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 emitters configured to transmit electromagnetic waves, in a plurality of cycles, at one or more a predetermined frequency (paragraph [0301], selectively turning on or off emitters (or emitter groups)), and intensity (paragraph [0306], comparison of the intensity signals of the fourth wavelength and a different wavelength), into the tissue of the wearer’s body, and each of the one more receivers configured to receive a return of the transmitted electromagnetic energy 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 assembly 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 electromagnetic radiation in a manner so as to penetrate a first depth within the tissue of the wearer’s body (paragraph [0270], the emitters can transmit optical radiation of a plurality of wavelengths into a tissue site), the first set of emitters each being formed of one or more electromagnetic wave emitters (paragraph [0278], Fig. 8F, LEDs 104) configured for emitting electromagnetic radiation of one or more: predetermined wavelengths (paragraph [0302], Fig. 13B, each of the emitters can be configured to emit light of a different wavelength than the other emitters), predetermined intensities (paragraph [0306], comparison of the intensity signals of the fourth wavelength and a different wavelength) or for a number of predetermined pulse durations (paragraph [0301], selectively turning on or off emitters (or emitter groups)), where each of the emitters is 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), and further wherein the first receiver is configured for detecting electromagnetic radiation of the first set of electromagnetic wave emitters returned back from the body’s tissue (paragraph [0270], the detectors can respond to the intensity of the optical radiation which can be reflected from the tissue site), and
the second sensor assembly comprising a second set of emitters positioned so as to be proximate a second receiver (paragraph [0280], Fig. 8F, detector group 106b and emitter group 104b), wherein the second set of emitters is formed of one or more additional electromagnetic wave emitters (paragraph [0278], Fig. 8F, LEDs 104) also configured for emitting electromagnetic radiation of one or more of: predetermined wavelengths (paragraph [0302], Fig. 13B, each of the emitters can be configured to emit light of a different wavelength than the other emitters), predetermined intensities (paragraph [0306], comparison of the intensity signals of the fourth wavelength and a different wavelength), or for a number of predetermined pulse durations (paragraph [0301], selectively turning on or off emitters (or emitter groups)), where each of the electromagnetic wave emitters is configured for being 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) so as to direct electromagnetic radiation in a manner so that it penetrates a second depth within the body’s tissue (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]), and further wherein the second receiver is configured for detecting the electromagnetic radiation of the electromagnetic wave 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 electromagnetic wave receivers being configured for collecting the electromagnetic radiation returned 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 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);
Al-Ali does not specifically disclose the one or more emitters configured to transmit electromagnetic waves, in one or more cycles, at a predetermined frequency, intensity, and duration of electromagnetic energy.
Ferber discloses the one or more emitters configured to transmit electromagnetic waves, in a plurality cycles, at a predetermined frequency, intensity, and duration of electromagnetic energy (paragraph [0100], energy transmitter 204 is configured to generate energy such that energy at different wavelengths 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 analyzing the digital signal data so as to produce electromagnetic radiation signature data, and analyzing the electromagnetic radiation signature data so as to thereby determine the concentration of the anayte being present in the tissue of the body of the wearer.
Mehnert discloses the server system (col. 20, lines 12-39, Fig. 5, server 130) comprising a first processing module having a first processor for analyzing the digital signal data so as to produce light signature data (col. 20, lines 12-39, Fig. 5, server 130 may analyze and/or process the sensor 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 (col. 20, lines 12-39, Fig. 5, server 130 may determine a blood sugar level measurement).
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 server as taught by Mehnert to determine how the data impacts or otherwise affects certain limits and/or goals (Mehnert, col. 20, lines 12-39).
Consider claim 23, the combination of Al-Ali, Ferber, and Mehnert discloses wherein the second sensor assembly comprises three electromagnetic wave emitters positioned so as to be proximate the first electromagnetic wave receiver (paragraph [0326], 16B, each group of emitters can include a different number of emitters (such as three emitters) proximate detectors 406a, 406b, see paragraph [0327], Fig. 16B).
Consider claim 26, the combination of Al-Ali, Ferber, and Mehnert discloses wherein the three electromagnetic wave emitters of the second sensor assembly are configured for emitting light of one or more of red, green, and infrared wavelengths (paragraph [0302], Fig. 13B, each of the LED emitters can be configured to emit light of a different wavelength than the other emitters to include wavelength having a red color (see paragraph [0304]), wavelength having a green color (see paragraph [0303]), and wavelength can be in the infrared range (see paragraph [0305])).
Consider claim 28, the combination of Al-Ali, Ferber, and Mehnert discloses wherein the second sensor assembly (paragraph [0339], Fig. 18B, second group of emitters 304b and detectors 306b) comprises a PPG sensor assembly (paragraph [0178], Figs 18B, plethysmograph sensor arrangement, where plethysmograph is commonly referred to as photoplethysmography (i.e., PPG as known in the art), see paragraph [0099]).
Consider claim 29, the combination of Al-Ali, Ferber, and Sim 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 30, the combination of Al-Ali, Ferber, and Mehnert 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 assembly (paragraph [0299], Figs. 12A, two electrodes 124 located on the sensor or module 100 where one is a reference electrode).
Consider claims 31, 46, the combination of Al-Ali, Ferber, and Mehnert discloses wherein the server system comprises an Artificial Intelligence module (Mehnert, col. 20, lines -39, server 130 may train machine learning models), and the Artificial Intelligence module is configured for receiving and analyzing the digital signal data so as to produce the electromagnetic signature results data (Mehnert, col. 20, lines 12-39, Fig. 5, machine learning model receives, analyze and/or process the sensor data).
Consider claims 33, 48, the combination of Al-Ali, Ferber, and Mehnert discloses wherein the ANN maps the electromagnetic radiation signature results data to the concentration of glucose (Mehnert, col. 20, lines 12-39, Fig. 5, server 130 may determine a blood sugar level measurement).
Consider claim 43, the combination of Al-Ali, Ferber, and Mehnert discloses wherein at least one of the first and second sensor assembly comprises three photoemitters positioned so as to be proximate at least one of the second receivers (paragraph [0338], Figs. 18A-19C, emitter group 304a, 304b includes three emitters proximate detectors 306a, 306b, 306a/b), the three photoemitters including a photoemitter configured for emitting red light (paragraph [0304], wavelength having a red color), a further photoemitter configured for emitting green light (paragraph [0303], wavelength having a green color), and an additional photoemitter configured for emitting infrared light (paragraph [0305], wavelength can be in the infrared range).
Consider claim 44, the combination of Al-Ali, Ferber, and Mehnert discloses wherein the at least one of the first and second sensor assembilies (paragraph [0339], Fig. 18B, second group of emitters 304b and detectors 306b) comprises a PPG sensor assembly (paragraph [0178], Figs 18B, plethysmograph sensor arrangement, where plethysmograph is commonly referred to as photoplethysmography (i.e., PPG as known in the art), see paragraph [0099]).
Consider claim 45, the combination of Al-Ali, Ferber, and Mehnert 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).
Claims 32 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Al-Ali, Ferber, and Mehnert in view of Sim et al. (Pub. No.: US 2019/0159705).
Consider claims 32, 47, the combination of Al-Ali, Ferber, and Mehnert discloses wherein the Artificial Intelligence module comprises a Machine Learning module (Mehnert, col. 20, lines -39, server 130 may train machine learning models).
The combination of Al-Ali, Ferber, and Mehnert does not specifically disclose a Machine Learning module and an Artificial Neural Network (ANN).
Sim discloses a Machine Learning module and an Artificial Neural Network (ANN) (paragraph [0048], performing machine learning using a convolutional neural network (CNN)).
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 Mehnert 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]).
Claims 34, 35, 49, and 50 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Al-Ali, Ferber, and Mehnert in view of Haas et al. (Pub. No.: US 2004/0033618).
Consider claims 34, 49, the combination of Al-Ali, Ferber, and Mehnert discloses wherein the characteristic skin response is determined in part by an absorption response of the skin (paragraph [0285], irradiating a larger volume of tissue and/or by increasing the amount of detected light, a larger sample size of light attenuated by the wearer's tissue can be measured).
the combination of Al-Ali, Ferber, and Mehnert does not specifically disclose wherein the mapping comprises comparing an intensity of a number of electromagnetic wavelengths to the absorption response of the skin so as to determine the electromagnetic signature, whereby a level of concentration of glucose can be determined by the electromagnetic 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 electromagnetic wavelengths to the absorption response of the skin so as to determine the electromagnetic 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 electromagnetic 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 claims 35, 50, the combination of Al-Ali, Ferber, Mehnert and Haas disclose wherein the determining of the absorption response is based on a non-linear relationship between changes of reflectance due to a range of different wavelengths (Haas, paragraph [0005], spectral data can exhibit a non-linear response due to both the properties of the substance being examined and/or inherent non-linearities in optical instrumentation).
Claim 36 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Al-Ali, Ferber, Mehnert and Haas in view of Miller et al. (Pat. No.: US 11,540,751).
Consider claims 36, 51, the combination of Al-Ali, Ferber, Mehnert 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, Mehnert 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 52 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Al-Ali, Ferber, and Mehnert in view of Bosua et al. (Pub. No.: US 11,284,819).
Consider claim 52, the combination of Al-Ali, Ferber, and Mehnert does not specifically disclose wherein the first sensor assembly comprises a microwave sensor configured for performing microwave spectroscopy.
Bosua discloses wherein the first sensor assembly comprises a microwave sensor configured for performing microwave spectroscopy (col. 8, lines 25-37, sensor system operatable by transmitting an electromagnetic signal in the microwave frequency range of the electromagnetic spectrum in FIGS. 1-5 and 9-12 wherein the non-invasive sensor using antennas can be used together with an LED sensor system to detect analyte, see col. 20, lines 29-41).
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 sensor assembly as disclosed by the combination of Al-Ali and Ferber with the sensor assembly as taught by Bosua to be used together with an LED sensor assembly to detect an analyte (Bosua, col. 20, lines 29-41).
Consider claim 53, the combination of Al-Ali, Ferber, and Mehnert does not specifically disclose wherein at least one of the first and second sensor assembly comprises a microwave sensor configured for performing microwave spectroscopy.
Bosua discloses wherein at least one of the first and second sensor assembly comprises a microwave sensor configured for performing microwave spectroscopy (col. 8, lines 25-37, sensor system operatable by transmitting an electromagnetic signal in the microwave frequency range of the electromagnetic spectrum in FIGS. 1-5 and 9-12 wherein the non-invasive sensor using antennas can be used together with an LED sensor system to detect analyte, see col. 20, lines 29-41).
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 at least one of the first and second sensor assembly as disclosed by the combination of Al-Ali and Ferber with the sensor assembly as taught by Bosua to be used together with an LED sensor assembly to detect an analyte (Bosua, col. 20, lines 29-41).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali in view of Ferber and further in view of Bosua et al. (Pub. No.: US 11,284,819).
Consider claim 37, Al-Ali discloses 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 reflectance 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 (paragraph [0006], 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) 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), the housing having a top cover (paragraph [0266], Figs. 1F, 3, display screen 12) and a bottom cover (paragraph [0251], Fig. 1F, skin-interfacing light transmissive cover 102), the bottom cover being configured to be held against the skin of the wearer (paragraph [0257], Fig. 1F, the convex cover 102 can be pressed onto the skin and the tissue 2 of the wearer);
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 detecting a characteristic skin response of one or more tissues of the body due to a presence of the analyte 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 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 assembly (paragraph [0280], Fig. 8F, detector group 106b and emitter group 104b) coupled therewith, each sensor assembly including a first number of electromagnetic wave 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), the one or more electromagnetic wave emitters configured to emit electromagnetic waves (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 each of the one more 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),
the first sensor assembly comprising a first plurality of electromagnetic wave emitters positioned proximate at least a first electromagnetic wave receiver (paragraph [0280], Fig. 8F, detector group 106a and emitter group 104a), each of the plurality of electromagnetic wave emitters being configured for emitting electromagnetic waves of a predetermined wavelength in one or more cycles (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) so as to generate a spectral related characteristic skin response in the tissues of the wearer, wherein the first electromagnetic wave receiver is configured for detecting electromagnetic waves of the first number of electromagnetic wave emitters transmitted 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 assembly comprises at least three 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), the at least three photoemitters including at least a first photoemitter configured for emitting light of a first wavelength, at least a second photoemitter configured for emitting light of a second wavelength, and at least a third photoemitter configured for emitting light of a third wavelength (paragraph [0302], Fig. 13B, each of the LED emitters can be configured to emit light of a different wavelength than the other emitters), wherein the second photoreceiver is configured for detecting light of the at least three photoemitters of the second assembly 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 emitters of the first and second sensor assembly are configured for directing the emitted energy 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 receivers are configured for converting the returned energy back form the body tissue 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 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
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 individual and independent activation of each of the emitters, whereby each emitter of the first and second sensor assemblies 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 [0301], selectively turning on or off emitters (or emitter groups)), 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 assemblies 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 emitter 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 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 does not specifically disclose a spectral microwave related characteristic skin response in the tissues of the wearer for the performance of microwave spectroscopy.
Bosua discloses a spectral microwave related characteristic skin response in the tissues of the wearer for the performance of microwave spectroscopy (col. 8, lines 25-37, sensor system operatable by transmitting an electromagnetic signal in the microwave frequency range of the electromagnetic spectrum in FIGS. 1-5 and 9-12 wherein the non-invasive sensor using antennas can be used together with an LED sensor system to detect analyte, see col. 20, lines 29-41).
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 sensor assembly as disclosed by the combination of Al-Ali and Ferber with the sensor assembly as taught by Bosua to be used together with an LED sensor assembly to detect an analyte (Bosua, col. 20, lines 29-41).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Al-Ali, Ferber, and Bosua in view of Mehnert.
Consider claim 38, the combination of Al-Ali, Ferber, and Bosua 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, Ferber, and Bosua does not specifically disclose the server system comprising a processing module for analyzing the digital signal data so as to produce microwave and optical spectral data, and for analyzing the spectral data so as to thereby determine a electromagnetic signature of the skin in response to receipt of the spectral of electromagnetic waves from which electromagnetic signature the concentration of the analyte being present in the skin tissue of the body of the wearer.
Mehnert discloses the server system (col. 20, lines 12-39, Fig. 5, server 130) comprising a processing module for analyzing the digital signal data so as to produce microwave and optical spectral data (col. 20, lines 12-39, Fig. 5, server 130 may analyze and/or process the sensor data), and for analyzing the spectral data so as to thereby determine a electromagnetic signature of the skin in response to receipt of the spectral of electromagnetic waves from which electromagnetic signature the concentration of the analyte being present in the skin tissue of the body of the wearer (col. 20, lines 12-39, Fig. 5, server 130 may determine a blood sugar level measurement).
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, Ferber, and Bosua with the server as taught by Mehnert to determine how the data impacts or otherwise affects certain limits and/or goals (Mehnert, col. 20, lines 12-39).
Claims 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Al-Ali, Ferber, Bosua, and Mehnert in view of Haas.
Consider claim 39, the combination of Al-Ali, Ferber, Bosua, and Mehnert discloses wherein the activation of the emitters in accordance with the predetermined wavelength, frequency, intensity, 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, Bosua, and Mehnert does not specifically disclose the processing module employs the pattern of absorption in determining the electromagnetic signature from which the concentration of the analyte being present in the tissue of the body of the wearer.
Haas discloses 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 (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 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, Bosua, Mehnert, and Haas discloses wherein the second sensor assembly comprises six photoemitters positioned proximate at least a first photoreceiver (paragraph [0326], 16B, first group of emitters 404A can include six emitters proximate detector 406a, see paragraph [0327], Fig. 16B),
The combination of Al-Ali, Bosua, Mehnert, and Haas discloses 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, Bosua, Mehnert, and Haas 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, Bosua, Mehnert, and Haas 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 41, the combination of Al-Ali, Ferber, Bosua, Mehnert, and Haas discloses wherein the second sensor assembly (paragraph [0339], Fig. 18B, second group of emitters 304b and detectors 306b), comprises a PPG sensor assembly (paragraph [0178], [0168], Figs 18B, plethysmograph sensor arrangement, where plethysmograph is commonly referred to as photoplethysmography (i.e., PPG), see paragraph [0099]), wherein the second photoreceiver is configured for detecting light of the PPG sensor assembly 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).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/Gerald Johnson/
Primary Examiner, Art Unit 3797
Prosecution Insights