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 1 is objected to because of the following informalities:
Claim 1 line 1 should include a colon “:” after “comprising”.
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 2-3 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 2 lines 2-3 recite “wherein in one state”, which creates confusion as to whether this is the same state or an alternative state to claim 1 lines 3-4 recitation of “wherein in one state”. There does not appear to be any alternative or additional “states” being claimed, although it does appear from the language that at least one other “state” is implied. Thus, the scope of the claim is unable to be determined, rendering the claim indefinite. Claim 3 is rejected due to its dependence upon rejected claim 2.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5-8, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Bly (US 20090076363 A1), Bunge (US 20120088990 A1), and Gerasopoulos (US 20200138343 A1).
Regarding claim 1, Bly teaches a body fluid-based biological detection apparatus, comprising
a water filter layer [Fig. 1J Item 162, 0093 “…cover 162 comprises a water repellent coating and/or layer on outside, for example a hydrophobic coating…”],
a middle layer [Fig. 1J Items 160-161], and
a flexible printed circuit board layer [Fig. 1J Item 120] in sequence from the bottom to the top [see Fig. 1J],
the flexible printed circuit board layer being integrated with a sensor [Fig. 1J Item 130, 00 “ Electronics circuitry 130 may comprise a temperature sensor…].
Bly teaches a water repellant layer, but fails to teach a membrane that filters the analyte wherein a molecularly imprinted polymer layer recognizes and binds a biomarker in the filtered body fluid, and the binding of the biomarker to the molecularly imprinted polymer layer results in a change in electrical current of the biochemical, so as to convert a biological signal in the body fluid into a physical signal.
Bunge teaches a membrane that filters the analyte [0038 “The semipermeable membrane, which filters the analyte into the interior of the sensor…”] wherein a molecularly imprinted polymer layer [0062 “The sensor system preferably has at least one region having a surface whereupon specific recognition markers for cells are located, wherein the recognition markers are selected from the group consisting of (…) molecularly imprinted polymers”] recognizes and binds a biomarker in the filtered body fluid [0075 “The surface of the implantable theranostic article can also undergo further modifications which bind or repel special constituents of the bodily fluid”], and the binding of the biomarker to the molecularly imprinted polymer layer results in a change in electrical current of the biochemical sensor [claim 2 “…wherein the sensor (14) is configured to generate an electrical signal dependent on the binding of at least one of the first characteristic carrier (16) and the second characteristic carrier (20) to the characteristic carrier receptor (18)”], so as to convert a biological signal in the body fluid into a physical signal [0076 “The sensor systems can also be used simultaneously for analyte measurement and for reference measurement”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Bly and incorporate the teachings of Bunge to include a membrane that filters the analyte wherein a molecularly imprinted polymer layer recognizes and binds a biomarker in the filtered body fluid, and the binding of the biomarker to the molecularly imprinted polymer layer results in a change in electrical current of the biochemical, so as to convert a biological signal in the body fluid into a physical signal. Doing so configures the system to filter out undesired particles to specifically target a marker of interest to provide for a more specific and accurate diagnosis of the patient’s condition, and to limit the amount of data processing required by inhibiting unwanted particles from being included in the measured data.
Bly teaches a sensor, but fails to teach the sensor is a biochemical sensor.
Gerasopoulos teaches the sensor is a biochemical sensor [0002 “…the present invention concerns wearable sensors for detecting biological molecules (also referred to as “biomarkers”) in a user's perspiration or skin”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Bly and incorporate the teachings of Gerasopoulos to include the sensor is a biochemical sensor. Doing so configures the sensor device to detect a chemical marker of interest to provide a user with information regarding the chemical marker’s presence so that treatment.
Regarding claim 5, Bly, Bunge, and Gerasopoulos teach the body fluid-based biological detection apparatus of claim 1, wherein the biochemical sensor comprises a biochemical sensor based on organic electrochemical transistors [Gerasopoulos 0015 “…the disposable sensor is contemplated to be a thin film transistor, such as an organic electrochemical transistor (“OECT”)”].
Regarding claim 6, Bly, Bunge, and Gerasopoulos teach the body fluid-based biological detection apparatus of claim 1, further comprising an intelligent terminal [Fig. 1J Item 130, 0060 “Electronic components 130 comprise components to take physiologic measurements, transmit data to remote center 106 and receive commands from remote center 106”], the intelligent terminal being connected to the flexible printed circuit board layer [Fig. 1J Item 120] through a network signal.
Regarding claim 7, Bly, Bunge, and Gerasopoulos teach the body fluid-based biological detection apparatus of claim 1, wherein the detection apparatus is wearable or adhesive [Bly abstract “An adherent device to monitor a patient for an extended period comprises a breathable tape. The breathable tape comprises a porous material with an adhesive coating to adhere the breathable tape to a skin of the patient”].
Regarding claim 8, Bly, Bunge, and Gerasopoulos teach the body fluid-based biological detection apparatus of claim 1, wherein the biomarker comprises biological metabolites [Bunge 0017 “metabolite”], hormones [Bunge 0017 “hormone”], electrolytes [Bunge 0017 “electrolyte” and proteins [Bunge 0017 “protein”].
Regarding claim 11, Bly teaches a body fluid-based biological detection method, comprising the following steps:
at S1, a water filter layer [Fig. 1J Item 162, 0093 “…cover 162 comprises a water repellent coating and/or layer on outside, for example a hydrophobic coating…”];
at S2, a middle layer [Fig. 1J Items 160-161];
and
at S4, a sensor [Fig. 1J Item 130, 00 “ Electronics circuitry 130 may comprise a temperature sensor…] analyzes the physical signal of the biomarker in the body fluid.
Bly teaches a water repellant layer, but fails to teach filtering the analyte wherein a molecularly imprinted polymer layer recognizes and binds a biomarker in the filtered body fluid, and the binding of the biomarker to the molecularly imprinted polymer layer results in a change in electrical current of the biochemical, so as to convert a biological signal in the body fluid into a physical signal.
Bunge teaches a membrane that filters the analyte [0038 “The semipermeable membrane, which filters the analyte into the interior of the sensor…”] wherein a molecularly imprinted polymer layer [0062 “The sensor system preferably has at least one region having a surface whereupon specific recognition markers for cells are located, wherein the recognition markers are selected from the group consisting of (…) molecularly imprinted polymers”] recognizes and binds a biomarker in the filtered body fluid [0075 “The surface of the implantable theranostic article can also undergo further modifications which bind or repel special constituents of the bodily fluid”], and the binding of the biomarker to the molecularly imprinted polymer layer results in a change in electrical current of the biochemical sensor [claim 2 “…wherein the sensor (14) is configured to generate an electrical signal dependent on the binding of at least one of the first characteristic carrier (16) and the second characteristic carrier (20) to the characteristic carrier receptor (18)”], so as to convert a biological signal in the body fluid into a physical signal [0076 “The sensor systems can also be used simultaneously for analyte measurement and for reference measurement”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Bly and incorporate the teachings of Bunge to include a membrane that filters the analyte wherein a molecularly imprinted polymer layer recognizes and binds a biomarker in the filtered body fluid, and the binding of the biomarker to the molecularly imprinted polymer layer results in a change in electrical current of the biochemical, so as to convert a biological signal in the body fluid into a physical signal. Doing so configures the system to filter out undesired particles to specifically target a marker of interest to provide for a more specific and accurate diagnosis of the patient’s condition, and to limit the amount of data processing required by inhibiting unwanted particles from being included in the measured data.
Bly teaches a sensor, but fails to teach the sensor is a biochemical sensor.
Gerasopoulos teaches the sensor is a biochemical sensor [0002 “…the present invention concerns wearable sensors for detecting biological molecules (also referred to as “biomarkers”) in a user's perspiration or skin”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Bly and incorporate the teachings of Gerasopoulos to include the sensor is a biochemical sensor. Doing so configures the sensor device to detect a chemical marker of interest to provide a user with information regarding the chemical marker’s presence so that treatment.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Bly, Bunge, and Gerasopoulos as applied to claim 1 above, and further in view of Wang (CN 113804732 A, machine translation provided via Espacenet <URL: https://worldwide.espacenet.com/patent/search/family/078941634/publication/CN113804732A?q=CN%20113804732%20A >) and Sussner (US 20180202961 A1).
Regarding claim 2, Bly, Bunge, and Gerasopoulos teach the body fluid-based biological detection apparatus of claim 1, wherein Bly teaches the printed circuit board and Bunge teaches the molecularly printed polymer layer and calculating a concentration of the biomarker [Bunge 0024 “The sensor system therefore operates using a particularly sensitive method based upon an immunological competition assay for detecting and/or for determining the concentration of the analyte in conjunction with its antagonist and the antigen binding partner thereof”], but fail to teach the flexible printed circuit board layer is further integrated with a humidity sensor, wherein in one state, the humidity sensor monitors the humidity around the detection apparatus and transmits humidity information in real time to the biochemical sensor, and the biochemical sensor analyzes and calculates the concentration of the biomarker taking the humidity data as a volumetric parameter of the body fluid and in combination with data of the biomarker transmitted by the molecularly imprinted polymer layer.
Wang teaches a humidity sensor [see machine translation page 7 line 17 “the MXene/PAAS humidity sensor”], the humidity sensor monitors the humidity around the detection apparatus [see machine translation page 7 lines 17-18 “…the MXene/PAAS humidity sensor was directly attached to the skin as a sweat rate monitoring device for real-time monitoring”] and transmits humidity information in real time to the biochemical sensor [see machine translation page 5 lines 23-25 “…the electrical signal transmitted by the conductive electrode is transmitted to the digital-to-analog conversion chip through the resistive voltage divider circuit…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Bly, Bunge, and Gerasopoulos and incorporate the teachings of Wang to include a humidity sensor, the humidity sensor monitors the humidity around the detection apparatus and transmits humidity information in real time to the biochemical sensor. Doing so configures the system to incorporate a humidity sensor into the system to calculate the amount of humidity present to aid in accurate calculation and correction of an acquired signal.
The combination of Bly, Bunge, Gerasopoulos, and Wang teach calculating a concentration of a biomarker, but fail to explicitly teach using humidity in the calculation of a biomarker.
Sussner teaches using humidity in the calculation of a biomarker [0038 “…the combined mass adsorbed, and the contribution of water is subtracted (or accounted for using algorithms, calibration curves or data, and/or look-up tables) from the combined mass of the analyte plus water vapor adsorbed in the sensing material 30 to determine the amount of the analyte present”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Bly, Bunge, Gerasopoulos, and Wang and incorporate teachings of Sussner to include using humidity in the calculation of a biomarker. Doing so configures the system to “…determine an accurate analyte value (e.g., mass or concentration) independent of humidity fluctuations”, as recognized by Sussner para. 0038.
Regarding claim 3, Bly, Bunge, Gerasopoulos, Wang, and Sussner teach the body fluid-based biological detection apparatus of claim 2, wherein the humidity sensor comprises an MXene-based humidity sensor [see Wang machine translation page 7 line 17 “the MXene/PAAS humidity sensor”].
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bly, Bunge, and Gerasopoulos as applied to claim 1 above, and further in view of Lieb (US 20200069227 A1).
Regarding claim 4, Bly, Bunge, and Gerasopoulos teach the body fluid-based biological detection apparatus of claim 1, wherein Bly teaches the water filter layer, but fails to teach the water filter layer comprises a UHMWPE membrane.
Lieb teaches the water filter layer comprises a UHMWPE membrane [0034 “…the pad 20 is formed from a polymer such as UHMWPE that is impervious to water…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Bly, Bunge, and Gerasopoulos and incorporate the teachings of Lieb to include the water filter layer comprises a UHMWPE membrane. Doing so configures the system to selectively remove water from the sample so as to protect the device components as well as remove undesired portions of the sample to improve the diagnostic efficiency of the system.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bly, Bunge, and Gerasopoulos as applied to claim 7 above, and further in view of Omoda (US 20110054273 A1).
Regarding claim 9, Bly, Bunge, and Gerasopoulos teach the body fluid-based biological detection apparatus of claim 7, wherein Bunge further teaches determining the concentration of analyte in a bodily fluid [0049 “…a determination of the concentration of the analyte, for example in bodily fluids, such as blood, urine, interstitial fluid or tears…”], but fails to explicitly teach the body fluid comprises sweat and sweat vapor.
Omoda teaches the body fluid comprises sweat and sweat vapor [0035 “…the sensor 114 acquires one or more chemical substances from a subject's skin (e.g., in sweat and/or sweat vapor or oil excretions) through the sample capture system…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Bly, Bunge, and Gerasopoulos and incorporate the teachings of Omoda to include the body fluid comprises sweat and sweat vapor. Doing so configures the system to evaluate levels of various substances in a patient’s sweat to evaluate the patient’s health condition, as recognized by Omoda para. 0002.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Bly, Bunge, and Gerasopoulos as applied to claim 1 above, and further in view of Lee (US 20180271393 A1).
Regarding claim 10, Bly, Bunge, and Gerasopoulos teach the body fluid-based biological detection apparatus of claim 1, but fail to teach wherein the thickness of the detection apparatus is 100-500 nm. Upon review of the disclosure, the range of thickness between 100-500 nm is not stated as critical or important (see Specification para. 0025).
However, Lee teaches a similar system in the same field of endeavor utilizing structures with a total thickness ranging between 100 nm to 100 µm [0051 “…yielding structures having a total thickness of about 100 nm to about 100 micrometers”].
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to adjust the thickness to an optimal range/value, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is thickness which achieves the recognized result of adjusting the size of the device to maximize sensing area to acquire more data that is incorporated into determining patient condition while also minimizing patient discomfort from having a device fixed to them, therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Bly, Bunge, and Gerasopoulos as applied to claim 11 above, and further in view of Ross (US 20190000357 A1).
Regarding claim 12, Bly, Bunge, and Gerasopoulos teach the body fluid-based biological detection method of claim 11, wherein the device measures analytes in bodily fluids [Bunge 0049], but fails to explicitly teach the body fluid comprises sweat and sweat vapor, the method further comprising the following steps: a detection result of a biomarker in sweat vapor in the case of unconscious sweating is used to correct a detection result of a biomarker in sweat of a subject.
Ross teaches the body fluid comprises sweat and sweat vapor [0045 “…the sweat vapor sensor 308 may be configured to measure chemical properties of the sweat vapor and may or may not measure a quantity of sweat, humidity, or temperature”], the method further comprising the following steps:
a detection result of a biomarker in sweat vapor in the case of unconscious sweating is used to correct a detection result of a biomarker in sweat of a subject [claim 13 “…the historic readings are selected to adjust the threshold based on corresponding readings from the sweat vapor sensor indicating that a target property of the one or more properties of the sweat vapor was present when the historic readings were taken”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Bly, Bunge, and Gerasopoulos and incorporate the teachings of Ross to include the body fluid comprises sweat and sweat vapor, the method further comprising the following steps: a detection result of a biomarker in sweat vapor in the case of unconscious sweating is used to correct a detection result of a biomarker in sweat of a subject. Doing so configures the system to “…increase the accuracy and consistency of the confirmation that the measuring device is functioning properly” as recognized by Ross para. 0102.
Conclusion
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/JONATHAN M HANEY/ Examiner, Art Unit 3791
/JUSTIN XU/ Primary Examiner, Art Unit 3791
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