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
Claims 13 - 15 are objected to because of the following informalities:
Claims 13 and 15 recite, “a transmitter receiver device,” while claim 14 which depends on claim 13 recites, “transmitter/receiver device”. Consistent language for each claim element should be used to improve the clarity of the claims. Examiner additionally notes that the specification uses “transmitter/receiver device” (paragraph [0053]), and suggests amending claims 13 and 15 to use the same phrase.
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 - 12 and 16 - 20 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.
In regard to claim 1, line 1 recites, “an apparatus for monitoring the biochemical activity of a wearer,” but “the biochemical activity” lacks antecedent basis. Claims 2 - 12 are rejected by virtue of dependence on claim 1.
In regard to claim 16, lines 7 - 9 recite, “one or more sensing circuits… to detect biochemical activity associated with the wearer of the biodegradable sensor;” However, “the biodegradable sensor” lacks antecedent basis. Further, it is unclear if claim 16 is requiring that the sensing circuits be biodegradable in order to meet the claim limitations. Examiner is interpreting claim 16 to only require a sensing circuit to detect a biochemical activity under broadest reasonable interpretation. Claims 17 - 20 are rejected by virtue of dependence on claim 16.
In regard to claim 18, line 1 recites, “the method of claim 15, further comprising…” However, claim 15 is directed towards a system claim and claim 18 includes details for a method of fabricating, which makes the metes and bounds of the claim unclear. Examiner is interpreting claim 18 to depend from independent claim 16 which is directed towards “A method for fabricating an apparatus”. Claims 19 - 20 are rejected by virtue of dependence on claim 18.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3 - 6, 9, 11, 13, 15, & 16 are rejected under 35 U.S.C. 103 as being unpatentable over Gao (US 20250000414 A1) in view of Feng (Feng J., et al. An Energy-Efficient Flexible Multi-Modal Wireless Sweat Sensing System Based on Laser Induced Graphene. Sensors (Basel). 2023;23(10):4818. Published 2023 May 17. doi:10.3390/s23104818) and further in view of Salvia (Salvia, A., et al., "Full-LIG Wireless Batteryless Sensor for the Detection of Amines," 2023 IEEE International Conference on Flexible and Printable Sensors and Systems (FLEPS), Boston, MA, USA, 2023, pp. 1-4, doi: 10.1109/FLEPS57599.2023.10220350.)
In regard to claims 1, 3 - 6, 9, & 11, Gao discloses an apparatus for monitoring the biochemical activity of a wearer (FIG. 1, component 100) that includes a base substrate layer (FIG. 2, component 228), an adhesive layer on a first side of the base substrate layer (FIG. 2, component FIG. 2B, component 222) and an encapsulation layer (FIG. 2B, component 230) made of PDMS, which one of ordinary skill in the art would recognize as inherently hydrophobic, and used to protect the sensor patch layer from biofluids that reduce the efficacy and longevity of the sensors in the base substrate layer (paragraphs [0091] & [0094]). The base substrate layer comprises a polyimide (PI) substrate (paragraph [0095]), which Examiner notes is a carbon based polymeric material, and includes one or more sensing circuits including electrolyte sensors (FIG. 1, components 105A - 105C; paragraph [0077]) that detect sodium, potassium, and/or ammonium, and metabolite sensors (FIG. 1, components 106A-106C) that detect lactate and/or glucose (paragraph [0078]) and a logical circuit for transmitting information indicative of the identified metabolite and electrolyte concentrations to a smart device (paragraph [0024]) where the wearable apparatus (FIG. 1, component 100) wirelessly communicates with the smart device (paragraph [0104]). Gao further discloses that the electrochemical sensors include an enzyme layer to detect biochemical activity (paragraph [0057]) and additionally that the one or more sensing circuits are configured to implement resistive or capacitive sensing (paragraph [0015]). The thickness of the device or the distance between a distal side of the adhesive layer and a distal side of the encapsulation layer is approximately 4 micrometers which is sufficiently within the range of 1 micrometer to 200 micrometers.
While Gao discloses that the electrolyte and metabolite sensors can comprise different materials (see Table 2, “substrate” and “functional materials”), and additionally that the sensors may be fabricated using laser engraving (paragraph [0100]), they do not specify that the base substrate layer has one or more LIG fabricated elements, including one or more sensing circuits.
However, Feng teaches a sweat sensing system based on LIG electrochemical sensors for the detection of sodium, potassium, glucose, and lactate using LIG electrochemical sensors fabricated on a PI film substrate (FIG. 1(d), see “LIG”; Section 2.3, “Fabrication of LIG Electrodes”). Feng further teaches that the sensing device is electrically passive and remains in “IDLE” mode in order to conserve the system’s energy efficiency until communication is established and all modules are enabled to “ACTIVE” state (Section 3.1.3: “DCU”).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus disclosed by Gao, which includes use of sensing circuits on a PI substrate that includes electrolyte sensors (FIG. 1, components 105A - 105C; paragraph [0077]) that detect sodium, potassium, and/or ammonium, and metabolite sensors (FIG. 1, components 106A-106C) that detect lactate and/or glucose (paragraph [0078]), with the teaching of Feng, which includes LIG electrochemical sensors for detecting sodium, potassium, lactate, and glucose because it would be considered a simple substitution of one known element, in this case the electrolyte and metabolite sensors disclosed by Gao, for another known element, the LIG electrolyte and metabolite sensors disclosed by Feng, to yield the predictable results of measuring a level of analyte in a user’s sweat.
While Gao discloses that the wearable apparatus (FIG. 1, component 100) wirelessly communicates with the smart device (paragraph [0104]) and Feng further teaches a wireless data relay (FIG. 2, see “Wireless Data Relay”), they do not specify that the base substrate layer has one or more LIG fabricated elements, including an inductor-capacitor circuit to receive a wireless signal and to provide passive wireless readouts.
However, Salvia teaches a zero-power LIG wireless sensor on a polyimide substrate (Section: “Abstract”) where the sensing element and communication antenna are made of LIG on the same polyimide substrates, where the communication antenna is an inductor-capacitor circuit (Section: “A. Antenna Design”; FIG. 3) which allows for the communication of wireless signals from the sensing device to an RFID reader and a smart device such as a PC (FIG. 6 a).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus disclosed by Gao, which includes the wireless communication of the monitoring device with a smart device (paragraph [0104]), with the teaching of Salvia that a zero-power LIG wireless sensor can be used to communicate wireless signals to a smart device (Section: “A. Antenna Design”; FIGs. 3 & 6) because it would be considered a simple substitution of one known element, in this case the communication circuit disclosed by Gao, for another known element, the LIG communication circuit taught by Salvia, to yield the predictable results of wirelessly transmitting a measurement value collected by a sensing device to an outside smart device.
In regard to claims 13 & 15, Gao discloses an apparatus for monitoring the biochemical activity of a wearer (FIG. 1, component 100) that includes a base substrate layer (FIG. 2, component 228), an adhesive layer on a first side of the base substrate layer (FIG. 2, component FIG. 2B, component 222) and an encapsulation layer (FIG. 2B, component 230) that is used to protect the sensor patch layer from biofluids that reduce the efficacy and longevity of the sensors in the base substrate layer (paragraphs [0091] & [0094]). The base substrate layer comprises a polyimide (PI) substrate (paragraph [0095]), which Examiner notes is a carbon based polymeric material, and includes one or more sensing circuits including electrolyte sensors (FIG. 1, components 105A - 105C; paragraph [0077]) that detect sodium, potassium, and/or ammonium, and metabolite sensors (FIG. 1, components 106A-106C) that detect lactate and/or glucose (paragraph [0078]) and a logical circuit for transmitting information indicative of the identified metabolite and electrolyte concentrations to a smart device (paragraph [0024]) where the wearable apparatus (FIG. 1, component 100) wirelessly communicates with the smart device (paragraph [0104]).
While Gao discloses that the electrolyte and metabolite sensors can comprise different materials (see Table 2, “substrate” and “functional materials”), they do not specify that the base substrate layer has one or more LIG fabricated elements, including one or more sensing circuits.
However, Feng teaches a sweat sensing system based on LIG electrochemical sensors for the detection of sodium, potassium, glucose, and lactate using LIG electrochemical sensors on a PI film substrate (FIG. 1(d), see “LIG”; Section 2.3, “Fabrication of LIG Electrodes”). Feng further teaches a transmitter/receiver device (FIG. 2; “Wireless Data Relay” and “BT interface”) that includes a transmitting controller to transmit wireless signals and receive data associated with the biochemical activity, data storage (FIG. 2, “Tablet PC”) to store the data associated with the biochemical activity (FIG. 5), and a battery to provide and regulate power for the biochemical sensor system (FIG. 2, “Power Management” and “Battery”). Feng additionally teaches that the device can be powered via Near-Field Communication (NFC) techniques, which one of ordinary skill in the art would recognize includes magnetic field induction for the transmission of power and data over short distances.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus disclosed by Gao, which includes use of sensing circuits on a PI substrate that includes electrolyte sensors (FIG. 1, components 105A - 105C; paragraph [0077]) that detect sodium, potassium, and/or ammonium, and metabolite sensors (FIG. 1, components 106A-106C) that detect lactate and/or glucose (paragraph [0078]), with the teaching of Feng, which includes LIG electrochemical sensors for detecting sodium, potassium, lactate, and glucose because it would be considered a simple substitution of one known element, in this case the electrolyte and metabolite sensors disclosed by Gao, for another known element, the LIG electrolyte and metabolite sensors disclosed by Feng, to yield the predictable results of measuring a level of analyte in a user’s sweat.
While Gao discloses that the wearable apparatus (FIG. 1, component 100) wirelessly communicates with the smart device (paragraph [0104]) and Feng further teaches a wireless data relay (FIG. 2, see “Wireless Data Relay”), they do not specify that the base substrate layer has one or more LIG fabricated elements, including an inductor-capacitor circuit to receive a wireless signal and to provide passive wireless readouts.
However, Salvia teaches a zero-power LIG wireless sensor on a polyimide substrate (Section: “Abstract”) where the sensing element and communication antenna are made of LIG on the same polyimide substrates, where the communication antenna is an inductor-capacitor circuit (Section: “A. Antenna Design”; FIG. 3) which allows for the communication of wireless signals from the sensing device to an RFID reader and a smart device such as a PC (FIG. 6 a).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus disclosed by Gao, which includes the wireless communication of the monitoring device with a smart device (paragraph [0104]), with the teaching of Salvia that a zero-power LIG wireless sensor can be used to communicate wireless signals to a smart device (Section: “A. Antenna Design”; FIGs. 3 & 6) because it would be considered a simple substitution of one known element, in this case the communication circuit disclosed by Gao, for another known element, the LIG communication circuit taught by Salvia, to yield the predictable results of wirelessly transmitting a measurement value collected by a sensing device to an outside smart device.
In regard to claim 16, Gao discloses a method for fabricating an apparatus for monitoring biochemical activity of a wearer, where the method comprises coating the base substrate (FIG. 4A; component 402), which includes a PI coating, with an encapsulation material, in this case PDMS (FIG. 4A, component 406; paragraph [0096]), on one side of the base substrate, providing an adhesive layer on the other side of the base substrate layer (FIG. 2B, component 222; paragraph [0093]), laser patterning the substrate (paragraph [0096]), and depositing electrode sensors, such as electrolyte and metabolite sensors (paragraph [0099]).
While Gao discloses forming one or more sensing elements to detect biochemical activity associate with the wearer of the biodegradable sensor, they do not specify that the method comprises forming one or more sensing circuits where the one or more sensing circuit is a LIG fabricated element formed on a base substrate layer.
However, Feng teaches the fabrication of LIG electrodes (FIG. 1D; Section 2.3. “Fabrication of LIG Electrodes”) which includes forming flexible sensor circuits for the detection of analytes such as sodium, potassium, glucose, and lactate, by laser engraving and inducing graphene electrodes into a PI substrate.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method disclosed by Gao, which includes the fabrication of sensing circuits on a PI substrate that includes electrolyte sensors (FIG. 1, components 105A - 105C; paragraph [0077]) that detect sodium, potassium, and/or ammonium, and metabolite sensors (FIG. 1, components 106A-106C) that detect lactate and/or glucose (paragraph [0078]), with the teaching of Feng, which includes the fabrication of LIG electrochemical sensors for detecting sodium, potassium, lactate, and glucose because it would be considered a simple substitution of one known element, in this case the method of fabricating electrolyte and metabolite sensors disclosed by Gao, for another known element, the fabrication of LIG electrolyte and metabolite sensors disclosed by Feng, to yield the predictable results of fabricating sensing circuits for measuring a level of analyte in a user’s sweat.
While Gao discloses that the wearable apparatus (FIG. 1, component 100) wirelessly communicates with the smart device (paragraph [0104]) and Feng further teaches a wireless data relay (FIG. 2, see “Wireless Data Relay”), they do not specify the method for forming a LIG fabricated inductor-capacitor circuit to receive a wireless signal and to provide passive wireless readouts onto a base substrate layer.
However, Salvia teaches a method for fabricating a zero-power LIG wireless sensor on a polyimide substrate where the communication antenna comprising an inductor-capacitor circuit is laser cut from a PI sheet (Section: “Abstract”; Section III: “Prototype and Measurements: A. Manufacturing”).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus disclosed by Gao, which includes the wireless communication of the monitoring device with a smart device (paragraph [0104]), with the teaching of Salvia of a method to fabricate an LIG inductor-capacitor circuit for communicating wireless signals to a smart device (Section: “A. Antenna Design”; FIGs. 3 & 6) because it would be considered combining prior art elements according to known methods to yield the predictable results of forming an element for wirelessly transmitting a measurement value collected by a sensing device to an outside smart device.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Gao (US 20250000414 A1) in view of Feng (Feng J., et al. An Energy-Efficient Flexible Multi-Modal Wireless Sweat Sensing System Based on Laser Induced Graphene. Sensors (Basel). 2023;23(10):4818. Published 2023 May 17. doi:10.3390/s23104818) and further in view of Salvia (Salvia, A., et al., "Full-LIG Wireless Batteryless Sensor for the Detection of Amines," 2023 IEEE International Conference on Flexible and Printable Sensors and Systems (FLEPS), Boston, MA, USA, 2023, pp. 1-4, doi: 10.1109/FLEPS57599.2023.10220350.) as applied to claim 1 above, and further in view of Rusu (Dan Rusu, R., & J.M. Abadie, M., New High-Performance Materials: Bio-Based, Eco-Friendly Polyimides. In Polyimide for Electronic and Electrical Engineering Applications. IntechOpen. 2021. https://doi.org/10.5772/intechopen.93340) and further in view of Mein (Mein J., et al.; Biodegradable electronics: cornerstone for sustainable electronics and transient applications. J. Mater. Chem. C 2016; 4 (24): 5531–5558.)
In regard to claim 2, Gao as modified discloses the invention of claim 1. While Gao discloses that the base substrate (FIG. 2B, component 228) is a polyimide substrate (paragraph [0095]) and Feng and Salvia further teach that the communications and sensor circuits are LIG elements, they do not specify that the base substrate layer, one or more LIG fabricated elements, adhesive layer, and encapsulation layer are biodegradable.
However, Rusu teaches that polyimides for biomedical applications can be biodegradable (Section: 4.1.4 “Biodegradation”).
It would have been obvious to one of ordinary skill in the art to have modified the apparatus disclosed by Gao as modified, which includes a polyimide substrate, with the teaching of Rusu that biodegradable polyimides can be used for biomedical applications, because Rusu further teaches that using biodegradable polyimides proves advantageous by minimizing environmental impact (Section: 4.1.4 “Biodegradation”).
Additionally, Mein teaches that other components of electronic devices for biomedical applications are biodegradable including PDMS based materials and graphene, (Section: 2. Materials for biodegradable electronics; 2.1 Substrate; “Synthetic polymers” and “Natural bio-degradable polymers”), circuits and conductors (Section: 2. Materials for biodegradable electronics; 2.2 Active Layer), electrodes (Section: 2. Materials for biodegradable electronics; 2.3 Electrodes), and adhesives and encapsulants (Section: 2. Materials for biodegradable electronics; 2.5 Adhesives/encapsulants).
It would have been obvious to one of ordinary skill in the art to have modified the apparatus disclosed by Gao as modified, which includes circuits for communicating wireless signals, sensing circuits, an adhesive layer, and an encapsulating layer comprising PDMS, with the teaching of Mein that biodegradable materials can be used for biomedical applications, because Mein further teaches that using biodegradable materials for biomedical applications and devices proves advantageous by minimizing health risks incurred during hazardous waste stream management (Section: 1. Introduction; “Why the need for bio-degradable (“green”) electronics?).
Claims 7 & 12 are rejected under 35 U.S.C. 103 as being unpatentable over Gao (US 20250000414 A1) in view of Feng (Feng J., et al. An Energy-Efficient Flexible Multi-Modal Wireless Sweat Sensing System Based on Laser Induced Graphene. Sensors (Basel). 2023;23(10):4818. Published 2023 May 17. doi:10.3390/s23104818) and further in view of Salvia (Salvia, A., et al., "Full-LIG Wireless Batteryless Sensor for the Detection of Amines," 2023 IEEE International Conference on Flexible and Printable Sensors and Systems (FLEPS), Boston, MA, USA, 2023, pp. 1-4, doi: 10.1109/FLEPS57599.2023.10220350.) as applied to claim 1 above, and further in view of Gao ‘942 (US 20200359942 A1).
In regard to claim 7, Gao as modified discloses the invention of claim 1. While Gao further discloses that the wearable device further includes one or more reference circuits comprising a reference electrode and counter electrode (FIG. 1B, component 121A, 121B, & 123; paragraph [0085]), which provide a static reference signal to compare with sensed signals, they do not specify that the reference receiver circuit is a LIG fabricated element.
However, Gao ‘942 teaches a wearable biosensor for detecting target molecules from a user (FIG. 1, component 100; paragraph [0005]) that includes a chemical sensor with a reference electrode and counter electrode manufactured using LIG where the electrodes are manufactured using laser engraving on PI film (paragraph [0066]; FIG. 3, component 301).
It would have been obvious to one of ordinary skill prior to the effective filing date of the claimed invention to have modified the apparatus disclosed by Gao as modified, which includes a reference receiver circuit to provide a static reference signal, with the teaching of Gao ‘942, which includes LIG electrodes for providing a reference signal, because it would be considered a simple substitution of one known element, in this case the reference and counter electrodes disclosed by Gao, for another known element, the reference and counter electrodes disclosed by Gao ‘942, to yield the predictable results of providing a static reference signal to compare with sensor signals.
In regard to claim 12, Gao as modified discloses the invention of claim 1. While Gao further discloses that the wearable device further includes the use of electrolyte and metabolite sensors (paragraph [0077]), where each sensor comprises a pin that acts as an electrode (paragraphs [0083] & [0085]), Gao does not specify that the one or more sensing circuits are configured to implement active sensing via generation of a voltage responsive to the biochemical activity.
However, Gao ‘942 teaches a wearable biosensor for detecting target molecules from a user (FIG. 1, component 100; paragraph [0005]) that includes a chemical sensor with an electrode (FIG. 1, component 130) configured to detect a measurement of an electrical property of a target molecule of interest (paragraph [0057]), including electrical voltage (paragraph [0058]), to detect the presence of the molecule.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified Gao as modified, which includes electrolyte and metabolite sensors comprising an electrode, with the teaching of Gao ‘942 that includes using an electrode to determine an electrical voltage associated with a molecule of interest to detect the presence of the molecule of interest, because it would be considered combining prior art elements according to known methods to yield the predictable result of detecting the presence of a molecule of interest using an electrode.
Claims 8 & 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gao (US 20250000414 A1) in view of Feng (Feng J., et al. An Energy-Efficient Flexible Multi-Modal Wireless Sweat Sensing System Based on Laser Induced Graphene. Sensors (Basel). 2023;23(10):4818. Published 2023 May 17. doi:10.3390/s23104818) and further in view of Salvia (Salvia, A., et al., "Full-LIG Wireless Batteryless Sensor for the Detection of Amines," 2023 IEEE International Conference on Flexible and Printable Sensors and Systems (FLEPS), Boston, MA, USA, 2023, pp. 1-4, doi: 10.1109/FLEPS57599.2023.10220350.) as applied to claim 1 above, and further in view of Schwartz (US 20160278638 A1).
In regard to claim 8, Gao as modified discloses the invention of claim 1. Gao further discloses that the wearable device for monitoring biochemical activity of a wearer (FIG. 1A, component 100) can include various biosensors including molecular biosensors and optical sensors (paragraph [0056]). While Gao indicates that the apparatus includes an optical sensor, they do not specify that the optical sensor is biodegradable or that the optical sensor comprises at least one photodetector and at least one photoemitter.
However, Schwartz teaches a polymeric wearable patch (paragraph [0032]) with an optical sensor arranged on the polymeric substrate of the patch to generate clinically relevant readings about an analyte of interest from the interstitial fluid of a user. The optical sensor comprises a photodetector and photoemitter (paragraph [0007]) and is embedded in a polymeric material configured to deteriorate over time (paragraph [0043]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to have modified the apparatus disclosed by Gao as modified, which includes an optical sensor (paragraph [0056]), with the teachings of Schwartz that an optical sensor comprises a photodetector and photoemitter and that the sensor is embedded in a biodegradable polymeric material, because Gao already discusses an optical sensor such that modifying Gao with the teachings of Schwartz would be considered simple substitution of one known element, in this case the optical sensor disclosed by Gao, for another known element, the optical sensor taught by Schwartz, to yield the predictable results of measuring an optical signal and detecting biochemical activity.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Gao (US 20250000414 A1) in view of Feng (Feng J., et al. An Energy-Efficient Flexible Multi-Modal Wireless Sweat Sensing System Based on Laser Induced Graphene. Sensors (Basel). 2023;23(10):4818. Published 2023 May 17. doi:10.3390/s23104818) and further in view of Salvia (Salvia, A., et al., "Full-LIG Wireless Batteryless Sensor for the Detection of Amines," 2023 IEEE International Conference on Flexible and Printable Sensors and Systems (FLEPS), Boston, MA, USA, 2023, pp. 1-4, doi: 10.1109/FLEPS57599.2023.10220350.) as applied to claim 1 above, and further in view of Veltz (US 20170173262 A1).
In regard to claim 10, Gao as modified discloses the invention of claim 1. While Gao discloses that their wearable device is used to identify concentrations of key biomarkers present in a biofluid sample, such as sweat, and additionally that the wearable device can include various biosensors, including enzymatic sensors and tissue-based sensors, they do not specify that the apparatus further comprises a subcutaneous sensor to perform a subcutaneous interrogation.
However, Veltz teaches a wearable patch for detecting a concentration of an analyte such as glucose (paragraph [0229]) where the sensor tip is inserted into the skin (paragraph [0233]). Veltz further teaches that sensors can be bioresorbable or biodegradable (paragraph [0232]).
It would be obvious to one of ordinary skill in the art to have modified the wearable device disclosed by Gao as modified, which includes a wearable patch with various sensors for measuring the concentration of an analyte such as glucose, with the teaching of Veltz that includes a subcutaneous and biodegradable glucose sensor attached to a wearable patch, because Gao already discusses the measurement of an analyte of interest from a biofluid sample using a variety of sensors such that modifying Gao as modified with the teachings of Veltz would be considered combining prior art elements according to known methods to yield the predictable result of determining a level of glucose in a biofluid.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Gao (US 20250000414 A1) in view of Feng (Feng J., et al. An Energy-Efficient Flexible Multi-Modal Wireless Sweat Sensing System Based on Laser Induced Graphene. Sensors (Basel). 2023;23(10):4818. Published 2023 May 17. doi:10.3390/s23104818) and further in view of Salvia (Salvia, A., et al., "Full-LIG Wireless Batteryless Sensor for the Detection of Amines," 2023 IEEE International Conference on Flexible and Printable Sensors and Systems (FLEPS), Boston, MA, USA, 2023, pp. 1-4, doi: 10.1109/FLEPS57599.2023.10220350.) as applied to claim 1 above, and further in view of Gudibande (US 20210212603 A1).
In regard to claim 14, Gao as modified discloses the invention of claim 13. While Feng teaches that the system includes a transmitter/receiver device that receives wireless signals (FIG. 2; “Wireless Data Relay” and “BT interface”), they do not specify that the transmitter/receiver device comprises a textile-based receiver element to receive the wireless signals.
However, Gudibande discloses a non-invasive analyte monitoring device for monitoring physiological signals such as glucose or lactate levels in sweat, where the device, which includes sensor elements and transmitter/receiver elements (paragraphs [0009] - [0011]) may be configured as a patch or other wearable (paragraph [0003]), such as integrated into a textile based clothing item like a shirt (paragraph [0093]).
It would have been obvious to one of ordinary skill prior to the effective filing date of the claimed invention to have modified the system disclosed by Gao as modified, which includes a transmitter/receiver device, with the teaching of Gudibande, that a sensor system including transmitter/receiver elements can be incorporated into a textile-based item such as a shirt, because both Gao as modified and Gudibande are interested in measuring analyte data from sweat, such that modifying Gao with the teaching of Gudibande that a sensing device can comprise a wearable patch or textile-based item would be considered combining prior art elements, in this case the application methods of analyte sensing devices, according to known methods to yield the predictable result of measuring analyte data from sweat using a wearable device.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Gao (US 20250000414 A1) in view of Feng (Feng J., et al. An Energy-Efficient Flexible Multi-Modal Wireless Sweat Sensing System Based on Laser Induced Graphene. Sensors (Basel). 2023;23(10):4818. Published 2023 May 17. doi:10.3390/s23104818) and further in view of Salvia (Salvia, A., et al., "Full-LIG Wireless Batteryless Sensor for the Detection of Amines," 2023 IEEE International Conference on Flexible and Printable Sensors and Systems (FLEPS), Boston, MA, USA, 2023, pp. 1-4, doi: 10.1109/FLEPS57599.2023.10220350.) as applied to claim 1 above, and further in view of Parmeggiani (Parmeggiani, M., et al., PDMS/Polyimide Composite as an Elastomeric Substrate for Multifunctional Laser-Induced Graphene Electrodes. ACS Appl. Mater. Interfaces 11 September 2019; 11 (36): 33221–33230).
In regard to claim 17, Gao as modified discloses the invention of claim 16. While Gao specifies that the substrate is a flexible polyimide substrate (paragraph [0095]), they do not specify that an elastomer material is added to increase the flexibility of the base substrate layer.
However, Parmeggiani teaches that substrates for stretchable electronics can be fabricated from polyimide/PDMS composites, where PDMS is an elastomer that allows for the manufacturing of sensor devices that are conformable to different shapes and surfaces (Section: Abstract).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method disclosed by Gao as modified, which includes the creation of an apparatus for monitoring biochemical activity of a wearer with a flexible polyimide substrate, with the teaching of Parmeggiani that the substrate for stretchable electronics can be a flexible polyimide/PDMS composite, because both Gao and Parmeggiani are interested in fabricating flexible sensing electronics such that modifying Gao as modified with the teachings of Parmeggiani would be considered simple substitution of one element, in this case the substrate material of Gao, for another, the substrate material of Parmeggiani, for the predictable result of fabricating a wearable sensing device. Additionally, Parmeggiani teaches that adding an elastomeric material to the substrate allows for the device to be conformable to any shape and surface (Section: Abstract).
Claims 18 - 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gao (US 20250000414 A1) in view of Feng (Feng J., et al. An Energy-Efficient Flexible Multi-Modal Wireless Sweat Sensing System Based on Laser Induced Graphene. Sensors (Basel). 2023;23(10):4818. Published 2023 May 17. doi:10.3390/s23104818) and further in view of Salvia (Salvia, A., et al., "Full-LIG Wireless Batteryless Sensor for the Detection of Amines," 2023 IEEE International Conference on Flexible and Printable Sensors and Systems (FLEPS), Boston, MA, USA, 2023, pp. 1-4, doi: 10.1109/FLEPS57599.2023.10220350.) as applied to claim 1 above, and further in view of Schwartz (US 20160278638 A1) and further in view of Leboeuf (US 20220313098 A1).
In regard to claims 18 - 20, Gao as modified discloses the invention of claim 16. Gao further discloses that the monitoring apparatus includes an optical sensor (paragraph [0056]). While Gao indicates that the apparatus includes an optical sensor, they do not specify that the optical sensor or device includes a photoemitter and photodetector or the depositing of a biodegradable material with respect to the one or more optical devices to form the base substrate layer.
However, Schwartz teaches a polymeric patch (paragraph [0032]) with an optical sensor arranged on the polymeric substrate of the patch to generate clinically relevant readings about an analyte of interest from the interstitial fluid of a user. The optical sensor comprises a photodetector and photoemitter (paragraph [0007]) and is embedded in a polymeric material configured to deteriorate over time (paragraph [0043]) where the optical detector is embedded within a biodegradable polymer substrate (paragraph [0032]) that is substantially transparent or translucent to allow for optical communication between the substrate and the sensor (paragraph [0043]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to have modified the apparatus disclosed by Gao as modified, which includes an optical sensor (paragraph [0056]), with the teachings of Schwartz that an optical sensor comprises a photodetector and photoemitter and that the sensor formed on a translucent substrate comprising a biodegradable polymeric material, because Gao already discusses an the integration of an optical sensor on a substrate such that modifying Gao with the teachings of Schwartz would be considered combining prior art elements according to known methods to yield the predictable result of incorporating an optical sensor into an apparatus to measure analytes in a biological fluid.
simple substitution of one known element, in this case the optical sensor disclosed by Gao, for another known element, the optical sensor taught by Schwartz, to yield the predictable results of measuring an optical signal and detecting biochemical activity.
While Gao as modified by Schwartz includes an optical sensor comprising a photodetector and photoemitter, they do not specify that the optical device includes a photoemitter surrounding a photodetector.
However, Leboeuf teaches a wearable biometric analysis device in the form of a wearable patch (FIG. 2, component 10; paragraph [0013]) with an optical detector that features a concentric ring configuration with a photodetector (FIG. 13A, component 114) located at the center of the optical device and surrounded by an inner and outer photoemitter (FIG. 13A, components 112a & 112b) to measure an analyte concentration (paragraph [0198]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to have modified the method disclosed by Gao as modified with the teaching of Leboeuf, which includes an optical detector with a concentric ring formation located on a wearable patch or substrate, because Gao and Schwartz both discuss the inclusion of an optical sensor or device on a polymeric substrate to measure an analyte level in a bodily fluid, such that modifying Gao as modified with the teachings of Leboeuf would be considered simple substitution of one element, in this case the optical sensor disclosed by Gao, for another, the optical sensor with concentric ring formation taught by Leboeuf, to obtain the predictable result of measuring an analyte level in a biological fluid.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Claussen (US 20210215636 A1) discloses fabrication methods for manufacturing flexible graphene circuits for bioelectrical sensing, including laser techniques (paragraph [0045]).
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
/S.C.P./Examiner, Art Unit 3791
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