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 .
Claim Objections
Claim 15 objected to because of the following informality:
“an statistical analysis” in line 14 should read “a statistical analysis”.
Claim 18 objected to because of the following informality:
“wherein device” in line 12 should read “wherein the device”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the scattered light" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the metabolic profile" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the detection of Raman scattering signals" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim, the written description must clearly define the claim term and set forth the definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “MCU” in claims 1, 5, and 8 are used by the claim to describe a controller and a processing unit, however this term is not commonly used or known in the art. The term is indefinite because the specification does not clearly define the term.
Claim 2 recites the limitation “the laser diode (110) or the IR diode (12) is placed inside or outside” in lines 1-2. It is unclear what is meant by the terms “inside” and “outside” in the context of the claims. Are these terms meant to refer to the inside or outside of the implantable device, the inside or outside of the user, or are these components located inside or outside with respect to a different component?
Claim 3 recites the limitation "the detection of specific metabolite-related Raman scattering light wavelengths" in line 4-5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 7, the phrase "like" in line 3 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 8 recites the limitation “generating light using laser diode (110) or IR diode (120) or optical waveguide ring (200) with laser diode (110) or IR diode (120)” in lines 3-4. As written, it is unclear whether what components may generate light. Is the claim intended to read “generating light using a laser diode (110), an IR diode (120), or an optical waveguide ring (200) with laser diode (110) or with IR diode (120)”? For the purpose of examination, claim is interpreted so that the light may be generated with a laser diode, IR diode, or optical waveguide ring.
Claim 8 recites the limitation “the subject’s tissue” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation “the Raman spectroscopy unit (140)” in lines 5-6. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation “the detection of Raman scattering signals” in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation “the Fabry-Pérot interferometer (150)” in lines 7-8. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation “the CMOS sensor (160)” in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation “the metabolite concentrations” in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation “the spacing” in line 13. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation “the piezo element (170a)” in line 14. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation “converting them” in line 2. It is unclear what the term “them” is referencing, which renders the claim indefinite. Additionally, the claim recites “processing this data” in line 3 and “this information” in line 4. It is unclear what data and information are referenced by the terms “this data” and “this data”, which renders the claim indefinite. Further clarification is required.
Claim 9 recites the limitation “the short-range wireless connectivity” in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation “the transmitted metabolite and identity information” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Claim 10 also recites “the metabolite concentration and identity information” in lines 5-6.
Claim 12 recites the limitation “this process” in line 4. It is unclear what is the term “this process” is referencing. Additionally, claim 12 recites the limitation “processing these signals” in line 4-5. It is unclear what the term “these signals” are referencing. Further clarification is required.
Regarding claim 13, the phrase "like" in line 1 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 13 recites the limitation “the data analysis” in line 2. There is insufficient antecedent basis for this limitation in the claim.
The term “various” in claim 14 is a relative term which renders the claim indefinite. The term “various” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what clinical settings are meant by the term “various clinical settings”. For the purpose of examination, the system may be used in any type of clinical setting.
Claim 15 recites the limitation "the system" in line 2. There is insufficient antecedent basis for this limitation in the claim, as claim 15 is written as an independent claim and therefore is not dependent on claim 10.
Claim 15 recites the limitation “the Fabry-Pérot interferometer (150)” in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation “the flat and spherical semi-transparent mirrors” in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “the data” in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear what data is being transmitted to the external device.
Claim 16 recites the limitation “it is processed” in line 2. It is unclear what is meant by the term “it”, which renders the claim indefinite.
Claim 16 recites the limitation “analyzed what includes comparison” in line 3. It is unclear what is meant by this language in the claim, which renders the claim indefinite.
Claim 16 recites the limitation “protecting this data” in line 4. It is unclear what the term “this data” is referencing. Which data is being protected?
Claim 18 recites the limitation “adapts its measurements” in lines 1-2. It is unclear what is meant by the term “its”, which renders the claim indefinite. For the purpose of examination, “its” is interpreted the implantable device.
The term “various” in claim 18 is a relative term which renders the claim indefinite. The term “various” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what clinical settings are meant by the term “various factors”. For the purpose of examination, the measurements may be based on any factors related to the subject.
Claim 18 recites the limitation “the data” in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear what data is informing the potential recommendations.
Regarding claim 19, the phrase "like" in line 1 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The term “various” in claim 19 is a relative term which renders the claim indefinite. The term “various” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what clinical settings are meant by the term “various clinical settings”. For the purpose of examination, the system may be used in any type of clinical setting.
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 1-13 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over US 20220415476 A1 (Connor, Robert A.) in view of US Patent No. 9/372,114 (Carr, William N.).
Regarding claim 1, Connor teaches an implantable device (100) for in vivo measurement of metabolites ([0101] “an implanted device can have a spectroscopic sensor.”; [0158]; [0392]):
wherein the implantable device (100) comprises
a laser diode (110) or an IR diode (120) ([0809] “In an example, a light emitter can be a laser diode. In an example, a light emitter can emit infrared or near-infrared light”),
an optical filter (130) that filters the scattered light ([0813] “a spectroscopic sensor can further comprise one or more optical filters”),
a Raman spectroscopy unit (140) for detecting the metabolic profile of a subject ([0177] “Raman spectroscopy sensor”; [0513] “Raman spectroscopic sensor”),
a Fabry-Pérot interferometer (150) ([0139] “optical filter (e.g. Fabry-Perot”) with a spherical mirror ([0139] “lens (e.g. spherical”), functioning as an etalon, for refining the detection of Raman scattering signals ([0502] “a Fabry-Perot spectroscopic sensor in the handheld or wearable device which emits light beams toward food and receives the light beams after the light beams have been reflected from (or passed through) food”),
a CMOS sensor (160) for capturing the refined Raman scattering signals ([0138] “complementary metal oxide semiconductor (CMOS)”; [0511]),
a piezo element (170a) or MEMS actuator (170b) for actuating the Fabry-Pérot interferometer (150) ([0139] “mirror (e.g. Digital Micromirror Device, parabolic reflector, Quasi Fresnel Reflector, mirror array); A Digital Micromirror Device is a micro-optoelectromechanical system),
MCU (180) as a controller and a processing unit ([0403] “data processing unit”; [0404] “a system can include a local (e.g. handheld or wearable) device which is in wireless electromagnetic communication with a remote (e.g. cloud-based) data processor.”).
Connor does not explicitly teach an implantable sensor comprising a Fabry-Pérot interferometer (150) with a spherical mirror, functioning as an etalon, for refining the detection of Raman scattering signals.
However,
Carr teaches an implantable sensor (Col. 3 lines 29-31 “implanting the spectrophotometer in animal tissue environments, such as for analyzing various compounds in the blood”) comprising a Fabry-Pérot interferometer (150) with a spherical mirror (Col. 1 lines 17-20 “FIG. 1 depicts a block diagram of a typical prior-art spectrophotometer 108 in use performing a spectral assay of media 104. Spectrophotometer 108 includes Fabry-Perot interferometer 112, detector(s) 116, and processor 120”), functioning as an etalon, for refining the detection of Raman scattering signals (Col. 2 lines 3-10 “An embodiment of conventional Fabry-Perot interferometer 112 is depicted in FIG. 2. Interferometer 112 consists of two spaced-apart mirrors 226 and 228. The mirrors are typically “highly” reflective, such that most of the light impinging on them is reflected. The change in the “thickness” of the lines that are representative of light “beam” is intended to be (qualitatively) indicative of the attenuation of the transmitted intensity resulting from reflections at mirror surfaces”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the device taught by Connor to include a Fabry-Pérot interferometer being a part of an implantable sensor. Connor teaches an embodiment using Fabry-Pérot in a handheld or wearable device, as described above. One would have been motivated to make this modification because the Fabry-Pérot interferometer is capable of spectrally measuring components within the blood of a patient, as suggested by Carr (Col. 5, lines 42-52).
Regarding claim 2, Connor teaches the implantable device (100) according to claim 1, wherein the laser diode (110) or the IR diode (120) is placed inside or outside as an optical waveguide ring (200) with laser diode (110) or IR diode (120) as a light source ([0809] “In an example, a light emitter can be a laser diode. In an example, a light emitter can emit infrared or near-infrared light”).
Regarding claim 3, Connor teaches the implantable device (100) according to claim 1, wherein the device includes the Fabry-Pérot interferometer (150) with flat and spherical semi-transparent mirrors and the piezo element (170a) or MEMS actuator (170b) to adjust spacing between semi- transparent mirrors, refining the detection of specific metabolite-related Raman scattering light wavelengths ([0147] “a spectroscopic sensor can have a moving micromirror array.”).
Connor does not explicitly wherein the device includes the Fabry-Pérot interferometer (150) with flat and spherical semi-transparent mirrors and the piezo element (170a) or MEMS actuator (170b) to adjust spacing between semi- transparent mirrors.
However,
Carr teaches wherein the device (Col. 3 lines 29-31 “implanting the spectrophotometer in animal tissue environments, such as for analyzing various compounds in the blood”) includes the Fabry-Pérot interferometer (150) (Col. 1 lines 17-20 “FIG. 1 depicts a block diagram of a typical prior-art spectrophotometer 108 in use performing a spectral assay of media 104. Spectrophotometer 108 includes Fabry-Perot interferometer 112, detector(s) 116, and processor 120”), with flat and spherical semi-transparent mirrors (Col. 2 lines 3-10 “An embodiment of conventional Fabry-Perot interferometer 112 is depicted in FIG. 2. Interferometer 112 consists of two spaced-apart mirrors 226 and 228. The mirrors are typically “highly” reflective, such that most of the light impinging on them is reflected. The change in the “thickness” of the lines that are representative of light “beam” is intended to be (qualitatively) indicative of the attenuation of the transmitted intensity resulting from reflections at mirror surfaces”) and the piezo element (170a) or MEMS actuator (170b) to adjust spacing between semi- transparent mirrors, refining the detection of specific metabolite-related Raman scattering light wavelengths (Col. 2 lines 33-47 “Electrostatic actuator 230 includes controlled voltage source 232. Mirrors 226 and 228 are electrically conductive, so that when a voltage is applied across them, an electrostatic force of attraction results. Mirror 226 is suspended (e.g., from a stationary substrate, etc.) via tethers 234 that enable mirror 226 to move. Consequently, when a voltage is applied across mirrors 226 and 228 creating an electrostatic force of attraction, tethered mirror 226 moves toward mirror 228. This movement reduces the size of gap G compared to the quiescent state in which no voltage is applied. Within the range of movement of mirror 226, the size of gap G is a function of voltage. Since, as already indicated, a change in cavity length alters the resonances of the interferometer, the transmission spectrum as a function of wavelength for interferometer 112 can be altered via electrostatic actuator 230”; Col. 5, lines 42-52).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the device taught by Connor to include the Fabry-Pérot interferometer being a part of an implantable sensor and the actuator adjusting the spacing between mirrors. Connor teaches an embodiment using Fabry-Pérot and moving mirrors in a handheld or wearable device, as described above. One would have been motivated to make this modification because the Fabry-Pérot interferometer is capable of spectrally measuring components within the blood of a patient and the wavelength of the interferometer can be adjusted to specify the spectrum for transmission by adjusting the spacing in the cavity, as suggested by Carr (Col. 5, lines 42-52; Col. 2 lines 33-47).
Regarding claim 4, Connor teaches the implantable device (100) according to claim 3, wherein the semi-transparent mirrors are created from an optical fiber bundle or an optical fiber plate or a homogenous glass ([0139] “optical fiber”).
Regarding claim 5, Connor teaches the implantable device (100) according to claim 1, wherein the MCU (180) as the data processing unit within the device analyzes interference fringes from Fabry-Pérot interferometer (150) as the CMOS sensor (160) generates electrical signal to determine metabolite identity and concentration ([0320]; [0884] “a device or system can measure nutrient density or concentration as part of an automatic food, ingredient, or nutrient identification method.”), employing machine learning or pattern recognition techniques aligned with known Raman spectra”; [1004] “machine learning”).
Connor does not explicitly teach Fabry-Pérot interferometer (150).
However,
Carr teaches Fabry-Pérot interferometer (150) (Col. 7 lines 10-14 “integrated Fabry-Perot interferometer 312, and various electronic devices and circuitry (e.g., processor 444, low-noise signal conditioning 446, analog-to-digital conversion 448, light source drivers 450, power supply 452, RF antenna 454, and RFID transponder 456)”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the device taught by Connor to include a Fabry-Pérot interferometer being a part of an implantable sensor. Connor teaches an embodiment using Fabry-Pérot in a handheld or wearable device, as described above. One would have been motivated to make this modification because the Fabry-Pérot interferometer is capable of spectrally measuring and processing components within the blood of a patient, as suggested by Carr (Col. 5, lines 42-52).
Regarding claim 6, Connor teaches the implantable device (100) according to claim 1, wherein the implantable device (100) encompasses a communication module, with wireless capabilities, to transmit metabolite data to external devices (210) for further processing, display or storage ([0368] “a system can visually display the results of image analysis and/or spectroscopic analysis of food items.”; [0403] “a data processing unit, memory, wireless data transmitter, and wireless data receiver.”).
Regarding claim 7, Connor teaches the implantable device (100) according to claim 1, wherein the implantable device (100) is biocompatible for long-term implantation ([0101] “implanted device”), supported by a power buffer unit, which can be recharged or sustained via energy harvested from external sources like inductive coupling ([0989] “power that is obtained, harvested, or transduced from a power source other than the person's body that is external to the device (such as a rechargeable battery, electromagnetic inductance from external source”).
Regarding claim 8, Connor teaches a method for in vivo measurement of metabolites using the implantable device (100) ([0101] “an implanted device can have a spectroscopic sensor.”; [0158]; [0392]), comprising steps of:
a. generating light using laser diode (110) or IR diode (120) or optical waveguide ring (200) with laser diode (110) or IR diode (120) ([0809] “In an example, a light emitter can be a laser diode. In an example, a light emitter can emit infrared or near-infrared light”),
b. generating Raman scattering signals from the subject’s tissue using the Raman spectroscopy unit (140) ([0177] “Raman spectroscopy sensor”; [0513] “Raman spectroscopic sensor”),
c. refining the detection of Raman scattering signals with the Fabry-Pérot interferometer (150) and flat and spherical semi-transparent mirrors ([0139]; [0147] “Fabry-Perot filter”; “a spectroscopic sensor can include a two-dimensional lens array”; [0502] “a Fabry-Perot spectroscopic sensor in the handheld or wearable device which emits light beams toward food and receives the light beams after the light beams have been reflected from (or passed through) food”),
d. capturing the refined Raman scattering signals using the CMOS sensor (160) ([0138] “complementary metal oxide semiconductor (CMOS)”; [0511]; [0513] “a Raman spectroscopic sensor in the handheld or wearable device which emits light beams toward food and receives the light beams after the light beams have been reflected from (or passed through) food”),
e. converting the captured Raman scattering signals into an electrical signal representative of the metabolite concentrations in the subject’s tissue using the CMOS sensor (160) ([0127]; [0511] “CMOS”; [0513] “wherein food images captured by the camera and changes in the spectra of the light beams caused by reflection from (or passage through) food are analyzed to identify food type, composition (e.g. nutritional composition), and/or quantity”; [0884] “a device or system can measure nutrient density or concentration as part of an automatic food, ingredient, or nutrient identification method”),
f. controlling the spacing between flat and spherical semi-transparent mirrors in the Fabry-Pérot interferometer (150) using the piezo element (170a) or MEMS actuator (170b) to fine-tune the detected Raman scattering signals ([0139] “mirror (e.g. Digital Micromirror Device, parabolic reflector, Quasi Fresnel Reflector, mirror array); A Digital Micromirror Device is a micro-optoelectromechanical system; [0147] “a spectroscopic sensor can have a moving micromirror array.”),
g. processing the electrical signal to determine the concentration and identity of the metabolites in the subject’s tissue using a MCU (180) as a data processing unit ([0403] “data processing unit”; [0404] “a system can include a local (e.g. handheld or wearable) device which is in wireless electromagnetic communication with a remote (e.g. cloud-based) data processor.”),
h. transmitting the metabolite concentration and identity information to an external device (210) for further analysis, display or storage using a communication module ([0295-0296]; [0313]; [0988] “a communications member to transmit data to from external sources and to receive data from external source”) and
i. powering the implantable device (100) using a power buffer unit and supplying the power through inductive coupling of external device (210) ([0989] “power that is obtained, harvested, or transduced from a power source other than the person's body that is external to the device (such as a rechargeable battery, electromagnetic inductance from external source”).
Connor does not explicitly teach refining the detection of Raman scattering signals with the Fabry-Pérot interferometer (150) and flat and spherical semi-transparent mirrors, and controlling the spacing between flat and spherical semi-transparent mirrors in the Fabry-Pérot interferometer (150) using the piezo element (170a) or MEMS actuator (170b) to fine-tune the detected Raman scattering signals.
However,
Carr teaches refining the detection of Raman scattering signals with the Fabry-Pérot interferometer (150) and flat and spherical semi-transparent mirrors (Col. 1 lines 17-20 “FIG. 1 depicts a block diagram of a typical prior-art spectrophotometer 108 in use performing a spectral assay of media 104. Spectrophotometer 108 includes Fabry-Perot interferometer 112, detector(s) 116, and processor 120”; Col. 2 lines 3-10 “An embodiment of conventional Fabry-Perot interferometer 112 is depicted in FIG. 2. Interferometer 112 consists of two spaced-apart mirrors 226 and 228. The mirrors are typically “highly” reflective, such that most of the light impinging on them is reflected. The change in the “thickness” of the lines that are representative of light “beam” is intended to be (qualitatively) indicative of the attenuation of the transmitted intensity resulting from reflections at mirror surfaces”), and
controlling the spacing between flat and spherical semi-transparent mirrors in the Fabry-Pérot interferometer (150) using the piezo element (170a) or MEMS actuator (170b) to fine-tune the detected Raman scattering signals (Col. 2 lines 33-47 “Electrostatic actuator 230 includes controlled voltage source 232. Mirrors 226 and 228 are electrically conductive, so that when a voltage is applied across them, an electrostatic force of attraction results. Mirror 226 is suspended (e.g., from a stationary substrate, etc.) via tethers 234 that enable mirror 226 to move. Consequently, when a voltage is applied across mirrors 226 and 228 creating an electrostatic force of attraction, tethered mirror 226 moves toward mirror 228. This movement reduces the size of gap G compared to the quiescent state in which no voltage is applied. Within the range of movement of mirror 226, the size of gap G is a function of voltage. Since, as already indicated, a change in cavity length alters the resonances of the interferometer, the transmission spectrum as a function of wavelength for interferometer 112 can be altered via electrostatic actuator 230”; Col. 5, lines 42-52).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Connor to include the Fabry-Pérot interferometer being a part of an implantable sensor and the actuator adjusting the spacing between mirrors. Connor teaches an embodiment using Fabry-Pérot and moving mirrors in a handheld or wearable device, as described above. One would have been motivated to make this modification because the Fabry-Pérot interferometer is capable of spectrally measuring components within the blood of a patient and the wavelength of the interferometer can be adjusted to specify the spectrum for transmission by adjusting the spacing in the cavity, as suggested by Carr (Col. 5, lines 42-52; Col. 2 lines 33-47).
Rgearding claim 9, Connor teaches the method involving the implantable device (100) according to claim 8, wherein the method includes steps of generating and refining Raman signals, converting them to an electrical representation, processing this data to discern metabolite details and transmitting this information externally, all powered via the short-range wireless connectivity ([0990] “the means of this wireless communication can be selected from the group consisting of: radio transmission, Bluetooth transmission, Wi-Fi, and infrared energy.”).
Regarding claim 10, Connor teaches a system for in vivo measurement of metabolites ([0101]; [0313-0314]), wherein the system comprises:
a. an implantable device (100) ([0101] “an implanted device can have a spectroscopic sensor.”; [0158]; [0392]),
b. an external device (210) for receiving and processing the transmitted metabolite concentration and identity information ([0295-0296]; [0313]; [0988] “a communications member to transmit data to from external sources and to receive data from external source”),
c. a user interface for displaying the metabolite concentration and identity information to a user ([0368-0369] “selected light colors and/or patterns can indicate high concentrations of selected types of ingredients, nutrients, and/or chemicals”; [0376] “a system can include a smart phone, wherein the results of spectroscopic analysis of food are shown on the phone's screen.”).
Regarding claim 11, Connor teaches the system according to claim 10, wherein the system receives updates to enhance performance, to interface with other devices or health records, and to generate alerts based on specific metabolite information parameters or thresholds ([0381] “a system can provide an alert, alarm, or warning when a person is approaching or exceeding a dietary goal or budget for quantity of food (or a particular nutrient) during a meal or during a period of time”).
Regarding claim 12, Connor teaches the system according to claim 10, wherein the implantable device (100) is placed within a subject to measure metabolite concentrations and identities in vivo using Raman scattering signals ([0101] “an implanted device can have a spectroscopic sensor”; [0127] “a system for nutritional monitoring and management can identify types of food items and/or their nutritional composition via spectroscopy”; “Raman spectroscopic sensor”), wherein
this process includes refining signals with a specific equipment and processing these signals to identify the metabolites ([0127] “a system for nutritional monitoring and management can identify types of food items and/or their nutritional composition via spectroscopy. In an example, types of food, ingredients, and/or nutrients can be identified by the spectral patterns of light which has been reflected from (absorbed by) food at different wavelengths”; [0313]).
Regarding claim 13, Connor teaches the system according to claim 10, wherein the system uses advanced techniques, like machine learning, and refines the data analysis, wherein users can access support channels for troubleshooting, and wherein training is provided to ensure proper system usage ([0325] “machine learning”; [0987]; [1004]; [1031]; [1039]).
Regarding claim 15, Connor teaches a method for monitoring metabolite concentrations and identities in a subject’s tissue using the system for in vivo measurement of metabolites ([0101]; [0313-0314]), comprising steps of:
a. implanting an implantable device (100) in a human or another animal body ([0101] “an implanted device can have a spectroscopic sensor.”; [0158]; [0392]),
b. measuring metabolite concentrations and identifying in vivo using the implantable device (100), including generating Raman scattering signals ([0177] “Raman spectroscopy sensor”; [0513] “Raman spectroscopic sensor”), refining the signals with the Fabry-Pérot interferometer (150) and the flat and spherical semi-transparent mirrors ([0139]; [0147] “Fabry-Perot filter”; “a spectroscopic sensor can include a two-dimensional lens array”; [0502] “a Fabry-Perot spectroscopic sensor in the handheld or wearable device which emits light beams toward food and receives the light beams after the light beams have been reflected from (or passed through) food”), capturing the signals using a CMOS sensor (160), and processing the signals to determine metabolite concentrations and identities ([0138] “complementary metal oxide semiconductor (CMOS)”; [0320] “nutrient density or concentration can be measured as part of an automatic food, ingredient, or nutrient identification method”; [0511]; [0513] “a Raman spectroscopic sensor in the handheld or wearable device which emits light beams toward food and receives the light beams after the light beams have been reflected from (or passed through) food”; [0884] “food density can be estimated by interacting food with light, sound, or electromagnetic energy and measuring the results of this interaction. Such interaction can include energy absorption or reflection.”),
c. transmitting the metabolite concentration and identity information from the implantable device (100) to an external device (210) using wireless communication protocols ([0295-0296]; [0313]; [0988] “a communications member to transmit data to from external sources and to receive data from external source”),
d. processing and analyzing the received metabolite concentration and identity information on the external device (210), including comparison with reference data trending or an statistical analysis ([0137] “modification of spectral distributions of light by food items can be compared to spectral distributions in a database of such spectral distributions to help identify food and the composition of ingredients/nutrients therein”; [0330]; [0439]),
e. displaying the metabolite concentration and identity information on a user interface ([0368-0369] “selected light colors and/or patterns can indicate high concentrations of selected types of ingredients, nutrients, and/or chemicals”; [0376] “a system can include a smart phone, wherein the results of spectroscopic analysis of food are shown on the phone's screen.”) and
f. generating alerts or notifications based on predetermined thresholds, patterns, or changes in the metabolite concentration and identity information using an alert module ([0381] “a system can provide an alert, alarm, or warning when a person is approaching or exceeding a dietary goal or budget for quantity of food (or a particular nutrient) during a meal or during a period of time”; [0404]).
Connor does not explicitly teach refining the signals with the Fabry-Pérot interferometer (150) and the flat and spherical semi-transparent mirrors.
However,
Carr teaches refining the signals with the Fabry-Pérot interferometer (150) and the flat and spherical semi-transparent mirrors (Col. 3 lines 29-31 “implanting the spectrophotometer in animal tissue environments, such as for analyzing various compounds in the blood”; Col. 1 lines 17-20 “FIG. 1 depicts a block diagram of a typical prior-art spectrophotometer 108 in use performing a spectral assay of media 104. Spectrophotometer 108 includes Fabry-Perot interferometer 112, detector(s) 116, and processor 120”; Col. 2 lines 3-10 “An embodiment of conventional Fabry-Perot interferometer 112 is depicted in FIG. 2. Interferometer 112 consists of two spaced-apart mirrors 226 and 228. The mirrors are typically “highly” reflective, such that most of the light impinging on them is reflected. The change in the “thickness” of the lines that are representative of light “beam” is intended to be (qualitatively) indicative of the attenuation of the transmitted intensity resulting from reflections at mirror surfaces”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Connor to include a Fabry-Pérot interferometer being a part of an implantable device. Connor teaches an embodiment using Fabry-Pérot in a handheld or wearable device, as described above. One would have been motivated to make this modification because the Fabry-Pérot interferometer is capable of spectrally measuring components within the blood of a patient, as suggested by Carr (Col. 5, lines 42-52).
Regarding claim 16, Connor teaches the method according to claim 15, wherein the implantable device (100) wirelessly transmits the data to the external device (210), where it is processed, stored for future reference and analyzed what includes comparison with other data and a potential for historical analysis, security and privacy mechanisms protecting this data ([0295-0296]; [0313]; [0988] “a memory to store, record, and retrieve data such as the cumulative amount consumed for at least one selected type of food, ingredient, or nutrient; a communications member to transmit data to from external sources and to receive data from external sources”; [0229] “relatively-low privacy intrusion”).
Regarding claim 17, Connor teaches the method according to claim 15, wherein the external device (210) provides a customizable user interface to display the metabolite data, generating alerts based on specific criteria and users receive updates or configuration changes for the system, and options for synchronization and integration with other devices or health records ([0072]; [0981]; [0282]; [0381] “In an example, a system can provide an alert, alarm, or warning when a person is approaching or exceeding a dietary goal or budget for quantity of food (or a particular nutrient) during a meal or during a period of time. In an example, a goal or budget for a quantity of food (or a particular nutrient) can be based at least in part on a person's dietary goals, energy balance goals, body weight goals, and/or energy expenditure during a period of time. In an example, a system can provide recommendations concerning goals for a person's nutritional intake, exercise level, and the relationship between them”).
Regarding claim 18, Connor teaches the method according to claim 15, wherein the implantable device (100) adapts its measurements based on various factors related to the subject, wherein device offers feedback to the subject or healthcare providers, including potential recommendations based on the data ([0400]; [0890]; [0987] “a device for measuring a person's consumption of at least one selected type of food, ingredient, or nutrient can provide feedback to the person that is selected from the group consisting of: advice concerning consumption of specific foods or suggested food alternatives (such as advice from a dietician, nutritionist, nurse, physician, health coach, other health care professional, virtual agent, or health plan); electronic verbal or written feedback (such as phone calls, electronic verbal messages, or electronic text messages); live communication from a health care professional”).
Claim 14 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 20220415476 A1 (Connor, Robert A.) in view of US Patent No. 9/372,114 (Carr, William N.), further in view of US 20240206783 A1 (Dubrovsky et al.).
Regarding claim 14, Connor teaches the system according to claim 10.
Connor does not explicitly teach wherein the system is used in diverse applications, including research and various clinical settings.
However,
Dubrovsky teaches wherein the system is used in diverse applications, including research and various clinical settings ([0086] “The assemblies may be configured for communication, biomedical, chemical, research, computing, or other applications”; [0275-0276]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the system taught by Connor to include usage in research and clinical settings. One would have been motivated to make this modification because the device can be used for diagnostics in research and biomedical settings, as suggested by Dubrovsky.
Regarding claim 19, Connor teaches the method according to claim 15, wherein advanced techniques, like machine learning, refine the data analysis, users access support channels for troubleshooting, wherein training is provided to ensure proper system usage ([0325] “machine learning”; [0987]; [1004]; [1031]; [1039]).
Connor does not explicitly teach wherein the system is used in diverse applications, including research and various clinical settings.
However,
Dubrovsky teaches wherein the system is used in diverse applications, including research and various clinical settings ([0086] “The assemblies may be configured for communication, biomedical, chemical, research, computing, or other applications”; [0275-0276]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the system taught by Connor to include usage in research and clinical settings. One would have been motivated to make this modification because the device can be used for diagnostics in research and biomedical settings, as suggested by Dubrovsky.
Conclusion
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/EVELYN GRACE PARK/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791