CTFR 18/856,679 CTFR 95845 Detailed Action Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Response to Amendment Claim 66 is added, and claims 1-3, 5-8, 13-14, 17-20, 23-25, 29, 37-38, 55, and 66 remain pending in the application in response to the applicant’s amendments to the rejections previously set forth in the Non-Final Office Action mailed 01/09/2026. Response to Arguments 07-37 AIA Applicant's arguments filed 04/09/2026 have been fully considered but they are not persuasive. For claim 1, the applicant argues “Ince describes the use of a fluorescence decay measurement as the means of determining tissue pCO2. This is distinctly different from the present invention, which makes use of changes in a chromophore's emission properties to determine pCO2.” (see pg. 12, para. 1 of applicant’s remarks), and the examiner disagrees. The claim does not specify what type of fluorescence response is detecting. Therefore, under broadest reasonable interpretation, Ince teaches a detecting a “fluorescence response”, which includes fluorescence decay. For claim 1, the applicant argues “the methods discussed in Ince, even in combination with Vurek, do not render the claimed invention obvious in that it is not at all obvious to one skilled in the art that a CO2 sensing "cup" as described in Ince plus Vurek's method would allow for CO2 sensing” (see pg. 13, para. 3), and the examiner disagrees . 07-37-13 AIA In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller , 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). 07-37-04 AIA In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine , 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones , 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc. , 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Vurek is used to teach a device including a photodetector and a sensing dye, while Ince is used to teach a photodetector detecting a fluorescence response of a sensing dye that provides tissue pCO2, as shown below . For claim 5, the applicant argues “Independent claim 5 recites a carbon dioxide permeable light redirection layer. A gold film is not carbon-dioxide permeable.” (see pg. 14, para. 1), and the examiner disagrees. Vurek teaches a CO2 permeable light redirection layer (see col. 15, lines 9-11 – “The light passes bidirectionally through CO2 pellet 18 and is reflected by the gold film positioned thereupon.” Where the CO2 permeable light redirection layer includes the CO2 pellet (CO2 permeable in order to detect CO2) and the gold film layer (light redirection)). For claim 24, the applicant argues “Therefore, it is not at all obvious in view of Vurek and Thomas to use an extraction technique (e.g., multiple linear regression) in the context of determining CO2” (see pg. 17, para. 2), and the examiner disagrees . 07-37-13 AIA In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller , 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). 07-37-04 AIA In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine , 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones , 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc. , 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Vurek is used to teach the measuring an amplitude of a measured sinusoidal response, and Thomas is used to teach extracting a value from a measured response via multiple linear regression, as shown below . Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-15 AIA Claim s 17 is rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Vurek et al. (US 5119463 A, published June 2, 1992), hereinafter referred to as Vurek . Regarding claim 17, Vurek teaches a device for carbon dioxide monitoring, the device comprising: a photoluminescent carbon dioxide-sensitive probe comprising a polymer matrix and a sensing dye (see col. 3, lines 25-30 "The first optical sensor and the exposed portions of the distal end of the optical waveguide are encased by a polymer matrix including a dye [sensing dye] that absorbs light of the first wavelength and transmits light of a second wavelength."); a first photon source configured to direct photons at a first wavelength at the probe; a second photon source configured to direct photons at a second wavelength at the probe, wherein the second wavelength is different from the first wavelength (see col. 14, lines 22-29 "Referring to FIGS. 1 and 5, compound probe 10 further comprises a sensing system 46. Sensing system 46 comprises a trio of light emitting diodes (LEDs) 48, 50, and 52. LED 48 produces a band of light centered about a wavelength of 555 nanometers; LED 50 produces a band of light centered about a wavelength of 585 nanometers; and LED 52 produces a band of light centered about a wavelength of about 615 nanometers." LEDs 48, 50, 52 as photon sources directing light with different wavelengths); a photodetector configured to detect light emitted from the probe when the first photon source and the second photon source direct photons at the probe (see col. 16, lines 24-29- "Signal555 is the reflected portion of the light pulse from LED48 that is detected by reflectance detector 66. Signal585 is the reflected portion of the light pulse from LED 50 that is detected by reflectance detector 74." Reflectance detectors 62, 66, and 74 as photodetectors); and a controller in electrical communication with the first photon source and the second photon source and the photodetector (Fig. 5, signal processor 80 (controller) in electrical communication with LEDs 48, 50, 52 (photon sources) and reflectance detectors 62, 66, and 74 (photodetectors)), the controller being configured to execute a program stored in the controller to calculate a level of carbon dioxide adjacent the probe from an electrical signal received from the photodetector (see col. 15,lines 21-26 "Reflectance detector 66 measures the amplitude of the reflected pulse from LED 48, microprocessor 80 [controller] uses a signal corresponding to this amplitude to determine the degree of absorption of the initial light pulse by the CO2 pellet 18, which is indicative of the level of CO2 [carbon dioxide] around probe 10."). wherein the first photon source and the second photon source are modulated by a sinusoidal voltage (see col. 14, lines 44-48 – “Reference detector 62 monitors the amplitude of the light pulse produced by LED 48 and in response, produces a reference signal that is used by microprocessor 80 to compensate for variations in the output of LED 48 and system losses [modulating photon source signals].”), and an intensity of a fluorescent response of the sensing dye is defined as an extracted amplitude of a measured sinusoidal response (see col. 17, lines 7-10 "Reflectance detector 74 measures the amplitude and produces a corresponding signal that is directed to microprocessor 80 for further processing..." where light is inherently a sinusoidal signal, and generating a light signal and measuring the amplitude of the light signal is known in the art) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim s 1-3, 5, 7, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Vurek in view of Ince (US 20070232874 A1, published October 4, 2007), hereinafter referred to as Ince . Regarding claim 1, Vurek teaches a device for carbon dioxide monitoring, the device comprising: a photoluminescent carbon dioxide-sensitive probe comprising a polymer matrix and a sensing dye (see col. 3, lines 25-30 "The first optical sensor and the exposed portions of the distal end of the optical waveguide are encased by a polymer matrix including a dye [sensing dye] that absorbs light of the first wavelength and transmits light of a second wavelength."); a photon source configured to direct photons at the probe (see col. 14, lines 22-29- "Referring to FIGS. 1 and 5, compound probe 10 further comprises a sensingsystem46. Sensing system46comprises a trio of light-emitting diodes (LEDs) 48, 50, and 52. LED 48 produces a band of light centered about a wavelength of 555 nanometers; LED 50 produces a band of light centered about a wavelength of 585 nanometers; and LED 52produces a band of light centered about a wavelength of about 615nanometers." LEDs 48, 50, 52 as photon sources directing light); a photodetector configured to detect light emitted from the probe when the photon source directs photons at the probe (see col. 16, lines 24-29 "Signal 555 is the reflected portion of the light pulse from LED 48 that is detected by reflectance detector 66. Signal585 is the reflected portion of the light pulse from LED 50 that is detected by reflectance detector 74." Reflectance detectors 62, 66, and 74 as photodetectors); and a controller in electrical communication with the photon source and the photodetector (Fig. 5, signal processor 80 (controller) in electrical communication with LEDs 48, 50, 52 (photon sources) and reflectance detectors 62, 66, and 74 (photodetectors)), the controller being configured to execute a program stored in the controller to calculate a level of carbon dioxide adjacent the probe from an electrical signal received from the photodetector (see col. 15,lines 21-26 "Reflectance detector 66 measures the amplitude of the reflected pulse from LED 48, microprocessor 80 [controller] uses a signal corresponding to this amplitude to determine the degree of absorption of the initial light pulse by the CO2 pellet 18, which is indicative of the level of CO2 [carbon dioxide] around probe 10."), wherein the polymer matrix comprises a polymer selected from the group consisting of acrylate polymers, methacrylate polymers, polyurethane polymers, and blends and copolymers thereof (see col. 8, lines 12-19 "Polymethylmethacrylate-based materials are an especially appropriate matrix component Methylmethacrylate can alternatively be copolymerized..."). Vurek teaches a photodetector, but does not explicitly teach where the photodetector detects a fluorescence response of the sensing dye that provides tissue pCO2. Whereas, Ince, in an analogous field of endeavor, teaches wherein the photodetector detects a fluorescence response of the sensing dye that provides tissue pCO2 (see para. 0044 "In this embodiment, a CO sensing dye can be impregnated with which CO can be sensed within the cup environment. The dye works to provide a fluorescence decay measurement and the excitation and emission light of this dye in the disposable tip can be measured through the light guide Furthermore, a CO probe may be inserted into the nose of a patient to assess tissue pCO2..."). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a photodetector, as disclosed in Vurek, by having the photodetector detect a fluorescence response of the sensing dye that provides tissue pCO2, as disclosed in Ince. One of ordinary skill in the art would have been motivated to make this modification in order to measure tissue wellness, as taught in Ince (see para. 0043). Furthermore, regarding claim 2, Vurek further teaches wherein: the polymer matrix comprises a hydrophobic polymer (see col. 13, lines 14-18 "This process results in a 10% solution of oxygen sensitive indicator polymer matrix designated as PT55, which, when solidified, is hydrophobic, but gas-permeable, and is used to form oxygen-sensitive polymer matrix coating 28."). Furthermore, regarding claim 3, Vurek further teaches wherein: the polymer matrix comprises a polymer selected from the group consisting of alkyl methacrylate polymers (see col. 9, lines 33-37 "In an alternative approach, the CO2 sensitive indicator molecule may be covalently bonded with the MMA/MAPTAC [methylmethacrylate/ methacrylamidopropyltrimethylammonium chloride] polymer using the aminoarylalkylamines [alkyl] noted earlier to form the CO2 polymer matrix solution."). Regarding claim 5, Vurek teaches a device for carbon dioxide monitoring, the device comprising: a photoluminescent carbon dioxide-sensitive probe comprising a polymer matrix and a sensing dye (see col. 3, lines 25-30 "The first optical sensor and the exposed portions of the distal end of the optical waveguide are encased by a polymer matrix including a dye [sensing dye] that absorbs light of the first wavelength and transmits light of a second wavelength."); a photon source configured to direct photons at the probe (see col. 14, lines 22-29 "Referring to FIGS. 1 and 5, compound probe 10 further comprises a sensing system46. Sensingsystem46comprises a trio of light-emitting diodes (LEDs) 48, 50, and 52. LED 48 produces a band of light centered about a wavelength of 555 nanometers; LED 50 produces a band of light centered about a wavelength of 585 nanometers; and LED 52 produces a band of light centered about a wavelength of about 615 nanometers." LEDs 48, 50, 52 as photon sources directing light); a photodetector configured to detect light emitted from the probe when the photon source directs photons at the probe (see col. 16, lines 24-29 "Signal555 is the reflected portion of the light pulse from LED 48 that is detected by reflectance detector 66. Signal585 is the reflected portion of the light pulse from LED 50that is detected by reflectance detector 74." Reflectance detectors 62, 66, and 74 as photodetectors); a carbon dioxide permeable light redirection layer, wherein the carbon dioxide- sensitive probe is positioned between the light redirection layer and the photodetector (Fig. 1, CO2 pellet 18 of CO sensitive indicator material 26 (carbon dioxide-sensitive probe) between reflective material 24 (light redirection layer) and optical waveguide 12 (includes a photodetector); see col. 15, lines 9-21 "The light passes bidirectionally through CO pellet 18 and is reflected by the gold film positioned thereupon The reflected light pulse is directed by optical splitter 60 to optical splitter 56, which in turn directs the reflected signal to a reflectance detector 66."); and a controller in electrical communication with the photon source and the photodetector (Fig. 5, signal processor 80 (controller) in electrical communication with LEDs 48, 50, 52 (photon sources) and reflectance detectors 62, 66, and 74 (photodetectors)), the controller being configured to execute a program stored in the controller to calculate a level of carbon dioxide adjacent the probe from an electrical signal received from the photodetector (see col. 15, lines 21-26 "Reflectance detector 66 measures the amplitude of the reflected pulse from LED 48, microprocessor 80 [controller] uses a signal corresponding to this amplitude to determine the degree of absorption of the initial light pulse by the CO2 pellet 18, which is indicative of the level of CO2 [carbon dioxide] around probe 10."). Furthermore, regarding claim 7, Vurek further teaches wherein: the light redirection layer is configured to reflect light (see col. 15, lines 9-11 "The light passes bidirectionally through CO2 pellet 18 and is reflected by the gold film [light redirection layer] positioned thereupon."). Furthermore, regarding claim 13, Vurek further teaches a partially air-impermeable layer positioned between the carbon dioxide-sensitive probe and the photodetector (see col. 7, lines 34-37 "Further, the polymer matrix must also permit free bidirectional movement of the subject analyte, i.e., the polymer matrix must be permeable to the CO2 and pH analytes [permeable togas, CO2]."). Furthermore, regarding claim 14, Vurek further teaches a partially air-impermeable outer layer (see col. 7, lines 34-37 "Further, the polymer matrix must also permit free bidirectional movement of the subject analyte, i.e., the polymer matrix must be permeable to the CO2 and pH analytes [permeable to gas, CO2].") . 07-21-aia AIA Claim s 6, 8, 37-38, and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Vurek in view of Ince, as applied to claim 5 above, and in further view of Kahlman et al. (US 20160331289 A1, published November17, 2016), hereinafter referred to as Kahlman . Regarding claim 6, Vurek in view of Ince teaches all of the elements disclosed in claim 5 above. Vurek in view of Ince teaches a light redirection layer, but does not explicitly teach wherein the light redirection layer is configured to scatter light. Whereas, Kahlman, in an analogous field of endeavor, teaches wherein: the light redirection layer is configured to scatter light (see para. 0062 "...the gas permeable layer [light redirection layer] is be adapted to reflect or scatter light transmitted through the at least one sensing layer, and/or to block possible light interferences outside of the intended sensor range."). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a light redirection layer, as disclosed in Vurek in view of Ince, by having the light redirection layer scatter light, as disclosed in Kahlman. One of ordinary skill in the art would have been motivated to make this modification in order for the gas-permeable layer may function as barrier to light and as permeable layer for small molecules such as CO 2 , as taught in Kahlman (see para. 0062). Furthermore, regarding claim 8, Kahlman further teaches wherein: the light redirection layer comprises a silicone film including a pigment (see para. 0061 "The gas-permeable layer may further be composed of filler material which is passable for gas molecules. An example of such filler material is silicone rubber material."). Furthermore, regarding claim 37, Kahlman further teaches wherein: the carbon dioxide-sensitive probe has a storage stability such that no significant decrease of sensitivity when the carbon dioxide sensitive probe is stored under ambient and dark conditions for at least seven days (see para. 0095 "In a further specific embodiment the present invention provides a chemo-optical sensor unit as defined herein which is provided in a conditioning fluid. The provision may be, for example, a packaging, storing, keeping, Suspending of the chemo-optical sensor in the conditioning fluid. This may be a short term activity, e.g. of10to 60 minutes, or 1 to 24 h, or a longer term activity of 1 day to several months or years, e.g. 2 months, 3 months, 4 months, 5 months, 6 months, 12 months, 24 months or more or anytime period in between the indicated values."). One of ordinary skill in the art would have been motivated to make this modification in order to keep the chemo-optical sensor unit in state which allows its immediate use or application without previous calibration or preparation steps, as taught in Kahlman (see para. 0095). Furthermore, regarding claim 38, Kahlman further teaches wherein: the device is an optical transcutaneous device (see para. 0118 "The chemo-optical sensor according to the present invention is suitable for transcutaneous measurement."). One of ordinary skill in the art would have been motivated to make this modification in order to perform non-invasive monitoring of partial pressure of CO2, as taught in Kahlman (see para. 0005). Furthermore, regarding claim 66, Kahlman further teaches a heater and/or thermistor (see para. 0123 – “…the heating element may be a resistance heater or diode so that the heating element can also be used as a temperature sensor, i.e. heating element and temperature sensor are formed by the same device.”). One of ordinary skill in the art would have been motivated to make this modification in order to reduce costs and space required for installation of a heater and temperature sensor, as taught in Kahlman (see para. 0123). The motivation for claim 8 was shown previously in claim 6 . 07-21-aia AIA Claim s 18 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Vurek in view of Gallant et al. (US 20140128694 A1, published May 8, 2014), hereinafter referred to as Gallant . Regarding claim 18, Vurek teaches all of the elements disclosed in claim 17 above. Vurek teaches directing light at a first wavelength, but does not explicitly teach an excitation spectrum of the sensing dye has an isosbestic point at the first wavelength. Whereas, Gallant, in an analogous field of endeavor, teaches wherein: an excitation spectrum of the sensing dye has an isosbestic point at the first wavelength (see para. 0186 "A desirable feature of this indicator is that the acidic (associated HPTS form) and basic (dissociated PTS-) forms have different excitation wavelengths at 406 and 460 nm, with an isosbestic point at 418 nm..."; see para. 0189 "The wavelength at which the absorption is the same for the acid and base forms of the dye is called the isobestic point..."). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified directing light at a first wavelength, as disclosed in Vurek, by having an excitation spectrum of the sensing dye has an isosbestic point at the first wavelength, as disclosed in Gallant. One of ordinary skill in the art would have been motivated to make this modification in order to make HPTS suitable for ratiometric detection of pH, as taught in Gallant (see para. 0186). Furthermore, regarding claim 29, Gallant further teaches wherein: the carbon dioxide-sensitive probe comprises a phase transfer reagent co-embedded with the sensing dye within the polymer matrix (see para. 0165 "In some instances, the sensing polymers are bonded to a surface such as the surface of a light conduit, or impregnated in a microporous membrane. In all cases, the matrix must not interfere with transport of the analyte to the binding sites so that equilibrium can be established between the two phases."). The motivation for claim 29 was shown previously in claim 18 . 07-21-aia AIA Claim s 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Vurek in view of Rice et al. (US 20180177443 A1, published June 28, 2018), hereinafter referred to as Rice . Regarding claim 19, Vurek teaches all of the elements disclosed in claim 17 above. Vurek teaches calculating the level of carbon dioxide adjacent the probe, but does not explicitly teach calculating the level of carbon dioxide adjacent the probe based on a normalization factor. Whereas, Rice, in an analogous field of endeavor, teaches wherein: the controller executes the program stored in the controller to calculate the level of carbon dioxide adjacent the probe based on a normalization factor determined by directing photons at the first wavelength at the probe to account for variations in brightness of the polymer matrix (Fig. 1 and 4; see para. 0069 "(4) calculate an intensity ratio, which is the ratio of the short-lifetime intensity to the long-lifetime intensity. Again, the intensity ratio can be used to normalize the analyte value for dynamic and tissue optics variations that occur in the tissue between single-channel sensor 110 and the surface of the skin where reader device 130, 1130 is located."). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified calculating the level of carbon dioxide adjacent the probe, as disclosed in Vurek, by calculating the level of carbon dioxide adjacent the probe based on a normalization factor, as disclosed in Rice. One of ordinary skill in the art would have been motivated to make this modification in order to determine an accurate analyte value, as taught in Rice (see para. 0069). Furthermore, regarding claim 20, Rice further teaches wherein: the controller is configured to execute the program stored in the controller to calculate the level of carbon dioxide adjacent the probe using a fluorescence ratio providing a metric that is proportional to the level of carbon dioxide adjacent the probe and is normalized using the normalization factor (Fig. 1 and 4; see para. 0069 "(4) calculate an intensity ratio, which is the ratio of the short-lifetime intensity to the long-lifetime intensity. Again, the intensity ratio can be used to normalize the analyte value for dynamic and tissue optics variations that occur in the tissue between single-channel sensor 110 and the surface of the skin where reader device 130, 1130 is located."; see para. 0035 "The short-lifetime analyte-sensing dye in single-channel sensor 110 is an analyte-specific dye sensitive to the analyte of interest (e.g., oxygen, glucose, lactate, carbon dioxide (CO )..."). The motivation for claim 20 was shown previously in claim 19 . 07-21-aia AIA Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Vurek in view of Wu (US 6436717 B1, published August 20, 2002), hereinafter referred to as Wu . Regarding claim 23, Vurek teaches all of the elements disclosed in claim 17 above. Vurek teaches calculating a level of carbon dioxide adjacent the probe from an electrical signal received from the photodetector, but does not explicitly teach calculating the level of carbon dioxide adjacent the probe by detecting intensity of the emission excited at the first wavelength and the second wavelength. Whereas, Wu, in an analogous field of endeavor, teaches wherein: thecontroller is configured to execute the program stored in the controller to calculate the level of carbon dioxide adjacent the probe by detecting intensity of the emission excited at the first wavelength and the second wavelength (see Abstract "...determining an analyte in which a dye Solution is illuminated to induce a first and a Second output light at a first and Second wavelength, respectively, and the analyte concentration is determined from the measured first and Second output intensities."). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified calculating a level of carbon dioxide adjacent the probe from an electrical signal received from the photodetector, as disclosed in Vurek, by calculating the level of carbon dioxide adjacent the probe by detecting intensity of the emission excited at the first wavelength and the second wavelength, as disclosed in Wu. One of ordinary skill in the art would have been motivated to make this modification in order for the system to be relatively insensitive to potential errors due to variations in the intensity of the illuminating light and to photobleaching of the dye Solution, as taught in Wu (see col. 6, lines 1-10) . 07-21-aia AIA Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Vurek in view of Thomas et al. (US 5355880A, published October 18, 1994), hereinafter referred to as Thomas . Regarding claim 24, Vurek teaches all of the elements disclosed in claim 17 above. Vurek teaches extracting the amplitude of a signal, but does not explicitly teach extracting the amplitude of a signal via multiple linear regression. Whereas, Thomas, in an analogous field of endeavor, teaches wherein: the amplitude of the measured sinusoidal response is extracted via multiple linear regression (see col. 24, lines44-45 "Multiple Linear Regression was used to analyze the Gaussian averaged intensity spectra."). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified extracting the amplitude of a signal, as disclosed in Vurek, by extracting the amplitude of a signal via multiple linear regression, as disclosed in Thomas. One of ordinary skill in the art would have been motivated to make this modification in order to be used even when there is overlap of spectral information from various components over all measured spectral regions, achieve increased precision from redundant information on in the spectra, can account for base line variations, can more fully model nonlinearities, and can provide outlier detection, as taught in Thomas (see col. 8, line 65 to col. 9, line 4) . 07-21-aia AIA Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Vurek in view of Gallant and Rice . Regarding claim 55, Vurek teaches a method for detecting a concentration of an analyte, the method comprising: (a) providing a device (Fig. 1, probe 10 as device) comprising: (i) a probe including a polymer matrix and a sensing dye (see col. 3, lines 25-30 "The first optical sensor and the exposed portions of the distal end of the optical waveguide are encased by a polymer matrix including a dye [sensing dye] that absorbs light of the first wavelength and transmits light of a second wavelength."), (ii) a first photon source configured to direct photons at a first wavelength at the probe, (iii) a second photon source configured to direct photons at a second wavelength at the probe, wherein the second wavelength is different from the first wavelength (see col. 14, lines 22-29 "Referring to FIGS. 1 and 5, compound probe 10 further comprises a sensing system46. Sensing system46 comprises a trio of light-emitting diodes (LEDs) 48, 50, and 52. LED 48 produces a band of light centered about a wavelength of 555 nanometers; LED 50 produces a band of light centered about a wavelength of 585 nanometers; and LED 52 produces a band of light centered about a wavelength of about 615 nanometers." LEDs 48, 50, 52 as photon sources directing light with different wavelengths), and (iv) a photodetector configured to detect light emitted from the probe when the first photon source and the second photon source direct photons at the probe (see col. 16, lines 24-29 "Signal555 is the reflected portion of the light pulse from LED48 that is detected by reflectance detector66. Signal585 is the reflected portion of the light pulse from LED 50 that is detected by reflectance detector 74." Reflectance detectors 62, 66, and 74 as photodetectors); and (b) calculating a concentration of the analyte adjacent the probe based on the light emitted from the probe detected by the photodetector (see col. 15,lines 21-26 "Reflectance detector 66 measures the amplitude of the reflected pulse from LED 48, microprocessor80 [controller] uses a signal corresponding to this amplitude to determine the degree of absorption of the initial light pulse by the CO2 pellet 18, which is indicative of the level ofCO2 [carbon dioxide] around probe 10."). Vurek teaches calculating a concentration of the analyte adjacent the probe based on the light emitted from the probe detected by the photodetector, but does not explicitly teach calculating a concentration of the analyte adjacent the probe based on an isosbestic point from an excitation spectrum of the sensing dye at the first wavelength. Whereas, Gallant, in an analogous field of endeavor, teaches calculating a concentration of the analyte adjacent the probe based on an isosbestic point from an excitation spectrum of the sensing dye at the first wavelength (see para. 0186 "A desirable feature of this indicator is that the acidic (associated HPTS form) and basic (dissociated PTS-) forms have different excitation wavelengths at 406 and 460 nm, with an isosbestic point at 418 nm..."; see para. 0189 "The wavelength at which the absorption is the same for the acid and base forms of the dye is called the isobestic point..."). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified calculating a concentration of the analyte adjacent the probe based on the light emitted from the probe detected by the photodetector, as disclosed in Vurek, by also calculating a concentration of the analyte adjacent the probe based on an isosbestic point from an excitation spectrum of the sensing dye at the first wavelength., as disclosed in Gallant. One of ordinary skill in the art would have been motivated to make this modification in order to make HPTS suitable for ratiometric detection of pH, as taught in Gallant (see para. 0186). Vurek in view of Gallant teaches calculating the concentration of the analyte adjacent the probe, but does not explicitly teach calculating the concentration of the analyte adjacent the probe based on a normalization factor. Whereas, Rice, in an analogous field of endeavor, teaches wherein step (b) further comprises calculating the concentration of the analyte adjacent the probe based on a normalization factor determined by directing photons at the first wavelength at the probe to account for variations in brightness of the polymer matrix (Fig. 1 and 4; see para. 0069 "(4) calculate an intensity ratio, which is the ratio of the short-lifetime intensity to the long-lifetime intensity. Again, the intensity ratio can be used to normalize the analyte value for dynamic and tissue optics variations that occur in the tissue between single-channel sensor 110 and the surface of the skin where reader device 130, 1130 is located."). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified calculating the concentration of the analyte adjacent the probe, as disclosed in Vurek in view of Gallant, by calculating the concentration of the analyte adjacent the probe based on a normalization factor, as disclosed in Rice. One of ordinary skill in the art would have been motivated to make this modification in order to determine an accurate analyte value, as taught in Rice (see para. 0069) . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure : Mauze et al. (US 6379969 B1, published April 30, 2002) discloses the sensing device 10 includes a sensor assembly, which is interrogated by a light source that shines and directs light of suitable wavelength (frequency) profile to the sensor assembly. The light source is preferably controlled by a processor to provide light at the desired wavelength and duration to interrogate the sensor assembly, causing a light interaction with the sensors in the sensor assembly. A light detector detects light resulting from the light interaction at the sensor assembly. Signals from the light detector are conveyed to a processor, preferably the same processor, for analysis to determine the presence and/or concentration of analytes in the unknown sample. Kane (US 20130323845 A1, published December 5, 2013) discloses a carbon dioxide detection system, where the light emitting component emits electromagnetic radiation that is received by the carbon dioxide sensor component. The electromagnetic radiation emitted by the light emit ting component interacts with the carbon dioxide sensor component, either by transmission or scattering, and the electromagnetic radiation, after the interaction, is received by the detector. Davenport et al. (WO 2016165838 A2, published October 20, 2016) discloses an optical sensor comprising first and second photoresponsive components that are each configured to fluoresce, responsive to excitation by light of a first wavelength, and emit light including a second and a third wavelength respectively; wherein the fluorescence of said first component varies with oxygen concentration of a medium with which the sensor is in contact, and the fluorescence of said second component varies with carbon dioxide concentration of a medium with which the sensor is in contact. X. Ge et al, “A Low-Cost Fluorescent Sensor for pCO2 Measurements”, Chemosensors, vol. 2, pp. 108-120, July 2013 discloses the LED light is modulated at approximately 10 kHz, which helps to suppress the influence of ambient light. The light intensity is converted into a voltage by a transimpedance amplifier, and the fluorescence amplitude is quantified using an on- board synchronous detector. The LEDs are fired sequentially, and the fluorescence intensity is measured. The ratio of the emissions is computed and the pCO2 data are recovered from a calibration curve. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL . See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nyrobi Celestine whose telephone number is 571-272-0129. The examiner can normally be reached on Monday - Thursday, 7:00AM - 5:00PM EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached on 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /N.C./Examiner, Art Unit 3798 /PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798 Application/Control Number: 18/856,679 Page 2 Art Unit: 3798 Application/Control Number: 18/856,679 Page 3 Art Unit: 3798 Application/Control Number: 18/856,679 Page 4 Art Unit: 3798 Application/Control Number: 18/856,679 Page 5 Art Unit: 3798 Application/Control Number: 18/856,679 Page 6 Art Unit: 3798 Application/Control Number: 18/856,679 Page 7 Art Unit: 3798 Application/Control Number: 18/856,679 Page 8 Art Unit: 3798 Application/Control Number: 18/856,679 Page 9 Art Unit: 3798 Application/Control Number: 18/856,679 Page 10 Art Unit: 3798 Application/Control Number: 18/856,679 Page 11 Art Unit: 3798 Application/Control Number: 18/856,679 Page 12 Art Unit: 3798 Application/Control Number: 18/856,679 Page 13 Art Unit: 3798 Application/Control Number: 18/856,679 Page 14 Art Unit: 3798 Application/Control Number: 18/856,679 Page 15 Art Unit: 3798 Application/Control Number: 18/856,679 Page 16 Art Unit: 3798 Application/Control Number: 18/856,679 Page 17 Art Unit: 3798 Application/Control Number: 18/856,679 Page 18 Art Unit: 3798 Application/Control Number: 18/856,679 Page 19 Art Unit: 3798 Application/Control Number: 18/856,679 Page 20 Art Unit: 3798 Application/Control Number: 18/856,679 Page 21 Art Unit: 3798 Application/Control Number: 18/856,679 Page 22 Art Unit: 3798
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