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 .
Notice of Amendment
In response to the amendment filed on 12/18/2025, amended claims 1 and 5-6, cancelled claims 7-20, and new claims 21-32 are acknowledged. Claims 1-6 and 21-32 remain pending. The following new and reiterated grounds of rejection are set forth:
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-6, 25, and 29-32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ochs (US Publication No. 2015/0230758 A1) (previously cited).
Regarding claim 1, Ochs discloses a method comprising:
providing a first enclosure comprising an oximeter sensor comprising a sensor head (312) comprising a first structure and a second structure, wherein the first structure is an emitter (316), the second structure is a detector (318, 338) (see [0064] – “Sensor unit 312 may include one or more light source 316 for emitting light at one or more wavelengths into a subject's tissue. Detectors 318 and 338 may also be provided in sensor unit 312 for detecting the light that is reflected by or has traveled through the subject's tissue. Any suitable configuration of light source 316 and detectors 318 and 338 may be used”), and the first enclosure comprises a first processing circuit (150, 170), a first display (182, 320), and a first transceiver within the first enclosure (190; see [0062] – “Communications interface 190 may include one or more receivers, transmitters, transceivers, antennas, plug-in connectors, ports, communications buses, communications protocols, device identification protocols, any other suitable hardware or software, or any combination thereof”), wherein the first processing circuit is coupled to the first display and the first transceiver (see Figures 1 and 3);
wirelessly coupling the oximeter sensor to a system unit (326) contained within a second enclosure that is separate from the first enclosure (see Figure 3) via a second transceiver of the system unit that is within the second enclosure, wherein the second transceiver communicates with the first transceiver through a wireless communication connection (332) passing from the first transceiver through the first enclosure and the second enclosure to the second transceiver, and the system unit comprises a second processing unit (see Figure 3 and [0065] – “In another embodiment, the sensor may be wirelessly connected (not shown) to monitor 314”, [0066] – “In some embodiments, a wireless transmission device (not shown) or the like may be used instead of or in addition to cable 324”, and [0069] – “Monitor 314 may be communicatively coupled to multi-parameter physiological monitor 326 via a cable 332 or 334 that is coupled to a sensor input port or a digital communications port, respectively and/or may communicate wirelessly (not shown). In addition, monitor 314 and/or multi-parameter physiological monitor 326 may be coupled to a network to enable the sharing of information with servers or other workstations (not shown)”);
receiving light and converting the light into electrical signal information using the detector (see [0035] – “After converting the received light to an electrical signal, detectors 140 and 142 may send the detection signals to monitor 104, where the detection signals may be processed and physiological parameters may be determined (e.g., based on the absorption of the red and IR wavelengths in the subject's tissue at both detectors).”);
converting the electrical signal information of the received light into digital signal information (see [0070] – “For example, processing equipment may be configured to amplify, filter, sample and digitize an input signal from sensor 102 or 312 (e.g., using an analog-to-digital converter), calculate physiological information and metrics from the digitized signal, and display a trace of the physiological information”);
using the first transceiver, transmitting the digital signal information over the direct communication connection to the system unit separate from the oximeter sensor (see [0062] – “Communications interface 190 may include one or more receivers, transmitters, transceivers, antennas, plug-in connectors, ports, communications buses, communications protocols, device identification protocols, any other suitable hardware or software, or any combination thereof” and [0069] – “Monitor 314 may be communicatively coupled to multi-parameter physiological monitor 326 via a cable 332 or 334 that is coupled to a sensor input port or a digital communications port, respectively and/or may communicate wirelessly (not shown). In addition, monitor 314 and/or multi-parameter physiological monitor 326 may be coupled to a network to enable the sharing of information with servers or other workstations (not shown)”);
using the second transceiver, receiving the digital signal information from the first transceiver of the oximeter sensor (see [0062] – “Communications interface 190 may include one or more receivers, transmitters, transceivers, antennas, plug-in connectors, ports, communications buses, communications protocols, device identification protocols, any other suitable hardware or software, or any combination thereof” and [0069] – “Monitor 314 may be communicatively coupled to multi-parameter physiological monitor 326 via a cable 332 or 334 that is coupled to a sensor input port or a digital communications port, respectively and/or may communicate wirelessly (not shown). In addition, monitor 314 and/or multi-parameter physiological monitor 326 may be coupled to a network to enable the sharing of information with servers or other workstations (not shown)”);
using the first processing circuit determining first oximeter information from the digital signal information using spatially resolved spectroscopy (see Figures 4 and 7 and [0030] – “For example, intensity signals for four wavelengths of light may be received at each of the near and far detectors, and the received intensity of each wavelength at the near detector may be subtracted from the received intensity of each wavelength at the far detector. The resulting light signals may be used to compute the regional blood oxygen saturation of a region of deep tissue through which light received at the far detector passed. Because the far detector receives light that passes through deep tissue in addition to the shallow tissue through which the light passes and is received at the near detector, the regional saturation may be computed for just the deep tissue by subtracting out the intensity received by the near detector. For example, a regional oximeter on a subject's forehead may include near and far detectors spaced from the light source such that the near detector receives light that passes through the subject's forehead tissue, including the superficial skin, shallow tissue covering the skull, and the skull, and the far detector receives light that passes through the forehead tissue and brain tissue (i.e., cerebral tissue). In the example, the differences in the light intensities received by the near and far detectors may be used to derive an estimate of the regional blood oxygen saturation of the subject's cerebral tissue (i.e., cerebral blood oxygen saturation)”);
displaying the first oximeter information on the first display (see [0065] – “Further, monitor 314 may include display 320 configured to display the physiological parameters or other information about the system” and [0088] – “When it is determined at step 608 that the curve fit for best fit reference is good enough, the processing equipment may, at step 612, display the rSO2 value. In some embodiments, the rSO2 value may be displayed on display 184 of FIG. 1, display 328 of multi-parameter physiological monitor 326 or display 320 of monitor 314 of FIG. 3, or any other suitable display for depicting physiological information”); and
displaying second oximeter information on a second display of the system unit determined from the digital signal information (see [0068] – “Multi-parameter physiological monitor 326 may be configured to calculate physiological parameters and to provide a display 328 for information from monitor 314 and from other medical monitoring devices or systems (not shown). For example, multi-parameter physiological monitor 326 may be configured to display an estimate of a subject's blood oxygen saturation and hemoglobin concentration generated by monitor 314” and [0088] – “When it is determined at step 608 that the curve fit for best fit reference is good enough, the processing equipment may, at step 612, display the rSO2 value. In some embodiments, the rSO2 value may be displayed on display 184 of FIG. 1, display 328 of multi-parameter physiological monitor 326 or display 320 of monitor 314 of FIG. 3, or any other suitable display for depicting physiological information”).
Regarding claim 2, Ochs discloses the first oximeter information and the second oximeter information are the same oximeter information (see [0068] – “Multi-parameter physiological monitor 326 may be configured to calculate physiological parameters and to provide a display 328 for information from monitor 314 and from other medical monitoring devices or systems (not shown). For example, multi-parameter physiological monitor 326 may be configured to display an estimate of a subject's blood oxygen saturation and hemoglobin concentration generated by monitor 314” and [0088] – “When it is determined at step 608 that the curve fit for best fit reference is good enough, the processing equipment may, at step 612, display the rSO2 value. In some embodiments, the rSO2 value may be displayed on display 184 of FIG. 1, display 328 of multi-parameter physiological monitor 326 or display 320 of monitor 314 of FIG. 3, or any other suitable display for depicting physiological information”).
Regarding claim 3, Ochs discloses the first oximeter information and the second oximeter information are different oximeter information (see [0068] – “Multi-parameter physiological monitor 326 may be configured to calculate physiological parameters and to provide a display 328 for information from monitor 314 and from other medical monitoring devices or systems (not shown). For example, multi-parameter physiological monitor 326 may be configured to display an estimate of a subject's blood oxygen saturation and hemoglobin concentration generated by monitor 314” and [0088] – “When it is determined at step 608 that the curve fit for best fit reference is good enough, the processing equipment may, at step 612, display the rSO2value. In some embodiments, the rSO2 value may be displayed on display 184 of FIG. 1, display 328 of multi-parameter physiological monitor 326 or display 320 of monitor 314 of FIG. 3, or any other suitable display for depicting physiological information”).
Regarding claim 4, Ochs discloses using a second processing unit of the system unit determining the second oximeter information from the digital signal information using spatially resolved spectroscopy (see Figures 4 and 7 and [0030] – “For example, intensity signals for four wavelengths of light may be received at each of the near and far detectors, and the received intensity of each wavelength at the near detector may be subtracted from the received intensity of each wavelength at the far detector. The resulting light signals may be used to compute the regional blood oxygen saturation of a region of deep tissue through which light received at the far detector passed. Because the far detector receives light that passes through deep tissue in addition to the shallow tissue through which the light passes and is received at the near detector, the regional saturation may be computed for just the deep tissue by subtracting out the intensity received by the near detector. For example, a regional oximeter on a subject's forehead may include near and far detectors spaced from the light source such that the near detector receives light that passes through the subject's forehead tissue, including the superficial skin, shallow tissue covering the skull, and the skull, and the far detector receives light that passes through the forehead tissue and brain tissue (i.e., cerebral tissue). In the example, the differences in the light intensities received by the near and far detectors may be used to derive an estimate of the regional blood oxygen saturation of the subject's cerebral tissue (i.e., cerebral blood oxygen saturation)”).
Regarding claim 5, Ochs discloses the first and second transceivers are both wireless transceivers and the wireless communication connection is a direct wireless connection (see [0062] – “Communications interface 190 may include one or more receivers, transmitters, transceivers, antennas, plug-in connectors, ports, communications buses, communications protocols, device identification protocols, any other suitable hardware or software, or any combination thereof. Communications interface 190 may be configured to allow wired communication (e.g., using USB, RS-232, Ethernet, or other standards), wireless communication (e.g., using WiFi, IR, WiMax, BLUETOOTH, USB, or other standards), or both”, [0066] – “In some embodiments, a wireless transmission device (not shown) or the like may be used instead of or in addition to cable 324”, and [0069] – “Monitor 314 may be communicatively coupled to multi-parameter physiological monitor 326 via a cable 332 or 334 that is coupled to a sensor input port or a digital communications port, respectively and/or may communicate wirelessly (not shown)”).
Regarding claim 6, Ochs discloses transmitting light from the first structure and the received light is based on the transmitted light (see [0033] – “Light source 130 may be configured to emit photonic signals having two or more wavelengths of light (e.g., red and IR) into a subject's tissue. For example, light source 130 may include a red light emitting light source and an IR light emitting light source, (e.g., red and IR light emitting diodes (LEDs)), for emitting light into the tissue of a subject to generate physiological signals. In one embodiment, the red wavelength may be between about 600 nm and about 700 nm, and the IR wavelength may be between about 800 nm and about 1000 nm. It will be understood that light source 130 may include any number of light sources with any suitable characteristics. In embodiments where an array of sensors is used in place of single sensor 102, each sensor may be configured to emit a single wavelength. For example, a first sensor may emit only a red light while a second may emit only an IR light. In some embodiments, light source 130 may be configured to emit two or more wavelengths of near-infrared light (e.g., wavelengths between 600 nm and 1000 nm) into a subject's tissue. In some embodiments, light source 130 may be configured to emit four wavelengths of light (e.g., 724 nm, 770 nm, 810 nm, and 850 nm) into a subject's tissue” and [0035] – “In some embodiments, an array of sensors may be used and each sensor in the array may be configured to detect an intensity of a single wavelength. In operation, light may enter detector 140 after passing through the subject's tissue, including skin, bone, and other shallow tissue (e.g., non-cerebral tissue and shallow cerebral tissue). Light may enter detector 142 after passing through the subject's tissue, including skin, bone, other shallow tissue (e.g., non-cerebral tissue and shallow cerebral tissue), and deep tissue (e.g., deep cerebral tissue). Detectors 140 and 142 may convert the intensity of the received light into an electrical signal. The light intensity may be directly related to the absorbance and/or reflectance of light in the tissue. That is, when more light at a certain wavelength is absorbed or reflected, less light of that wavelength is received from the tissue by detectors 140 and 142. After converting the received light to an electrical signal, detectors 140 and 142 may send the detection signals to monitor 104, where the detection signals may be processed and physiological parameters may be determined (e.g., based on the absorption of the red and IR wavelengths in the subject's tissue at both detectors)”).
Regarding claim 25, Ochs discloses the sensor head comprises a third structure and a fourth structure, the third structure is an emitter, and the fourth structure is a detector (see [0029] – “In some embodiments, the regional oximeter's light source may include two or more emitters and one or more detectors” and [0033] – “Sensor 102 of physiological monitoring system 100 may include light source 130, detector 140, and detector 142. Light source 130 may be configured to emit photonic signals having two or more wavelengths of light (e.g., red and IR) into a subject's tissue. For example, light source 130 may include a red light emitting light source and an IR light emitting light source, (e.g., red and IR light emitting diodes (LEDs)), for emitting light into the tissue of a subject to generate physiological signals”).
Regarding claim 29, Ochs discloses coupling a first battery to the first transceiver, wherein the battery is enclosed in the first enclosure (see [0065] – “Sensor unit 312 may be powered by an internal power source, e.g., a battery (not shown)”).
Regarding claim 30, Ochs discloses the system unit comprises a second battery that is different and independent of the first battery (see [0069] – “Monitor 314 may be powered by a battery (not shown) or by a conventional power source such as a wall outlet”).
Regarding claim 31, Ochs discloses transmitting light from the first structure generated by the emitter into tissue, wherein the receiving the light comprises receiving the received light at the second structure from the tissue based on the transmitted light transmitted into tissue (see [0035] – “Light may enter detector 142 after passing through the subject's tissue, including skin, bone, other shallow tissue (e.g., non-cerebral tissue and shallow cerebral tissue), and deep tissue (e.g., deep cerebral tissue). Detectors 140 and 142 may convert the intensity of the received light into an electrical signal. The light intensity may be directly related to the absorbance and/or reflectance of light in the tissue. That is, when more light at a certain wavelength is absorbed or reflected, less light of that wavelength is received from the tissue by detectors 140 and 142. After converting the received light to an electrical signal, detectors 140 and 142 may send the detection signals to monitor 104, where the detection signals may be processed and physiological parameters may be determined (e.g., based on the absorption of the red and IR wavelengths in the subject's tissue at both detectors). In some embodiments, one or more of the detection signals may be preprocessed by sensor 102 before being transmitted to monitor 104”).
Regarding claim 32, Ochs discloses controlling the emitter by the first processing circuit to generate the generated light that is transmitted by the source structure (see [0038] – “Light drive circuitry 120, as discussed above, may be configured to generate a light drive signal that is provided to light source 130 of sensor 102. The light drive signal may, for example, control the intensity of light source 130 and the timing of when light source 130 is turned on and off. In some embodiments, light drive circuitry 130 provides one or more light drive signals to light source 130. Where light source 130 is configured to emit two or more wavelengths of light, the light drive signal may be configured to control the operation of each wavelength of light. The light drive signal may comprise a single signal or may comprise multiple signals (e.g., one signal for each wavelength of light)”).
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ochs, further in view of Bechtel et al. (US Publication No. 2013/0317331 A1).
Regarding claim 21, it is noted Ochs does not specifically teach the digital signal information comprises first information and second information for absorption coefficient information and scattering coefficient information, the absorption coefficient information and scattering coefficient information are independent information; and the method further comprising using the first processing circuit, determining a first value for the absorption coefficient information from the digital signal information using spatially resolved spectroscopy, wherein the first value for the absorption coefficient information is independent of scattering coefficient information; using the first processing circuit, determining first oximeter information based on the determining of the first value for the absorption coefficient information from the digital signal information; using the second processing circuit, determining a second value for the absorption coefficient information from the digital signal information using spatially resolved spectroscopy, wherein the second value for the absorption coefficient information is independent of scattering coefficient information; and using the second processing circuit, determining second oximeter information based on the determining of the second value for the absorption coefficient information from the digital signal information. However, Bechtel et al. teaches the digital signal information comprises first information and second information for absorption coefficient information and scattering coefficient information, the absorption coefficient information and scattering coefficient information are independent information (see [0061] – “Thus, by measuring reflectance at relatively small source-detector distances (e.g., D1 between light source 120a and detector 125e and D9 between light source 120c and detector 125a) and relatively large source-detector distances (e.g., D5 between light source 120a and detector 125a and D10 between light source 120c and detector 125e), both .mu..sub.a and .mu..sub.s' can be independently determined from one another”); and the method further comprising using the first processing circuit, determining a first value for the absorption coefficient information from the digital signal information using spatially resolved spectroscopy, wherein the first value for the absorption coefficient information is independent of scattering coefficient information (see Figure 5A and [0044] – “According to one specific implementation, a relatively small set of simulated reflectance curves that are a "coarse" grid of the database of the simulated reflectance curves is selected and utilized for fitting step 520. For example, given 39 scattering coefficient .mu..sub.s' values and 150 absorption coefficient .mu..sub.a values, a coarse grid of simulated reflectance curves might be determined by processor 116 by taking every 5th scattering coefficient .mu..sub.s' value and every 8th absorption coefficients .mu..sub.a for a total of 40 simulated reflectance curves in the coarse grid”); using the first processing circuit, determining first oximeter information based on the determining of the first value for the absorption coefficient information from the digital signal information (see [0054] – “According to a first implementation, processor 116 determines the oxygen saturation for tissue that is probed by tissue oximetry device 100 by utilizing the absorption coefficients .mu..sub.a (e.g., 3 or 4 absorption coefficients .mu..sub.a) that are determined (as described above) for the 3 or 4 wavelengths of light that are generated by each light source 120. According to a first implementation, a look-up table of oxygen saturation values is generated for finding the best fit of the absorption coefficients .mu..sub.a to the oxygen saturation”); using the second processing circuit, determining a second value for the absorption coefficient information from the digital signal information using spatially resolved spectroscopy, wherein the second value for the absorption coefficient information is independent of scattering coefficient information (see Figure 5A and [0044] – “According to one specific implementation, a relatively small set of simulated reflectance curves that are a "coarse" grid of the database of the simulated reflectance curves is selected and utilized for fitting step 520. For example, given 39 scattering coefficient .mu..sub.s' values and 150 absorption coefficient .mu..sub.a values, a coarse grid of simulated reflectance curves might be determined by processor 116 by taking every 5th scattering coefficient .mu..sub.s' value and every 8th absorption coefficients .mu..sub.a for a total of 40 simulated reflectance curves in the coarse grid”); and using the second processing circuit, determining second oximeter information based on the determining of the second value for the absorption coefficient information from the digital signal information (see [0054] – “According to a first implementation, processor 116 determines the oxygen saturation for tissue that is probed by tissue oximetry device 100 by utilizing the absorption coefficients .mu..sub.a (e.g., 3 or 4 absorption coefficients .mu..sub.a) that are determined (as described above) for the 3 or 4 wavelengths of light that are generated by each light source 120. According to a first implementation, a look-up table of oxygen saturation values is generated for finding the best fit of the absorption coefficients .mu..sub.a to the oxygen saturation”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Ochs to include the digital signal information comprises first information and second information for absorption coefficient information and scattering coefficient information, the absorption coefficient information and scattering coefficient information are independent information; and the method further comprising using the first processing circuit, determining a first value for the absorption coefficient information from the digital signal information using spatially resolved spectroscopy, wherein the first value for the absorption coefficient information is independent of scattering coefficient information; using the first processing circuit, determining first oximeter information based on the determining of the first value for the absorption coefficient information from the digital signal information; using the second processing circuit, determining a second value for the absorption coefficient information from the digital signal information using spatially resolved spectroscopy, wherein the second value for the absorption coefficient information is independent of scattering coefficient information; and using the second processing circuit, determining second oximeter information based on the determining of the second value for the absorption coefficient information from the digital signal information, as disclosed in Bechtel et al., so as to provide sufficient information for the calculation of oxygenated hemoglobin and deoxygenated hemoglobin concentrations and hence the oxygen saturation of the tissue (see Bechtel et al.: [0061]).
Regarding claim 22, Bechtel et al. teaches independence of the absorption coefficient information and scattering coefficient information of the digital signal information is based on a separation of the first and second structures (see [0061] – “Thus, by measuring reflectance at relatively small source-detector distances (e.g., D1 between light source 120a and detector 125e and D9 between light source 120c and detector 125a) and relatively large source-detector distances (e.g., D5 between light source 120a and detector 125a and D10 between light source 120c and detector 125e), both .mu..sub.a and .mu..sub.s' can be independently determined from one another”).
Claim(s) 23-24 and 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ochs, further in view of Bechtel et al. (US Publication No. 2014/0046152 A1; hereinafter referred to as Bechtel #2) (cited by Applicant).
Regarding claim 23, it is noted Ochs does not specifically teach the sensor head comprises a surface area that will contact a tissue to be measured is from about 28 square millimeters to about 63 square millimeters. However, Bechtel #2 teaches a surface area that will contact a tissue to be measured is from about 28 square millimeters to about 63 square millimeters (see [0122] – “That is, the circle on which light detectors 170 are arranged may have a diameter of about 3 millimeters to about 10 millimeters (e.g., 4 millimeters according to one specific embodiment)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Ochs to include the sensor head comprises a surface area that will contact a tissue to be measured is from about 28 square millimeters to about 63 square millimeters, as disclosed in Bechtel #2, so as to substantially limit reflectance data to light that propagated within the top layer of tissue wherein little or no underlying subcutaneous fat or muscular layers contributes to the reflectance data generated by the light detectors from light reflected from tissue (see Bechtel #2: [0123]).
Regarding claim 24, it is noted Ochs does not specifically teach a distance between the first and second structures is from about 10 millimeters or less. However, Bechtel #2 teaches a distance between the first and second structures is from about 10 millimeters or less (see Figures 9A-B and [0128] – “At least one source-to-detectors distances is about 1.5 millimeters or less (e.g., 0.5 millimeters up to about 1.7 millimeters), and at least one source-to-detectors distances is about 2.5 millimeters or greater (e.g., 1.5 millimeters up to about 3.2 millimeters)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Ochs to include a distance between the first and second structures is from about 10 millimeters or less, as disclosed in Bechtel #2, so as to obtain greater accuracy, faster calibration, and redundancy (see Bechtel #2: [0128]).
Regarding claim 26, it is noted Ochs does not specifically teach a distance between the first and fourth structures is about 10 millimeters. However, Bechtel #2 teaches a distance between the first (e.g. 150a) and fourth structures (e.g. 170a) is about 10 millimeters (see Figures 9A-B and [0122] – “That is, the circle on which light detectors 170 are arranged may have a diameter of about 3 millimeters to about 10 millimeters (e.g., 4 millimeters according to one specific embodiment)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Ochs to include a distance between the first and fourth structures is about 10 millimeters, as disclosed in Bechtel #2, so as to obtain greater accuracy, faster calibration, and redundancy (see Bechtel #2: [0128]).
Regarding claim 27, it is noted Ochs does not specifically teach a distance between the third and fourth structures is from about 10 millimeters or less. However, Bechtel #2 teaches a distance between the third and fourth structures is from about 10 millimeters or less (see Figures 9A-B and [0128] – “At least one source-to-detectors distances is about 1.5 millimeters or less (e.g., 0.5 millimeters up to about 1.7 millimeters), and at least one source-to-detectors distances is about 2.5 millimeters or greater (e.g., 1.5 millimeters up to about 3.2 millimeters)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Ochs to include a distance between the third and fourth structures is from about 10 millimeters or less, as disclosed in Bechtel #2, so as to obtain greater accuracy, faster calibration, and redundancy (see Bechtel #2: [0128]).
Regarding claim 28, it is noted Ochs does not specifically teach a first distance between the first and second structures, a second distance between the first and fourth structures, a third distance is between the second and third structures, and the first, second, and third distances are different from each other. However, Bechtel #2 teaches a first distance between the first and second structures, a second distance between the first and fourth structures, a third distance is between the second and third structures, and the first, second, and third distances are different from each other (see Figures 9A-B and [0129] – “For example, in one embodiment, a first source-to-detector distance is about 1.5 millimeters or less. A second source-to-detector distance is about 1.5 millimeters or less. A third source-to-detector distance is about 2.5 millimeters or greater. A fourth source-to-detector distance is about 2.5 millimeters or greater”; see also [0130] and [0133]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Ochs to include a first distance between the first and second structures, a second distance between the first and fourth structures, a third distance is between the second and third structures, and the first, second, and third distances are different from each other, as disclosed in Bechtel #2, so as to obtain greater accuracy, faster calibration, and redundancy (see Bechtel #2: [0128]).
Response to Arguments
Applicant's arguments filed 12/18/2025 have been fully considered but they are not persuasive.
Applicant argues that the Ochs sensor head is separated from any of Ochs enclosures that include any of Ochs processing units and transceivers and thus Ochs transmissions are not transmitted through any enclosures that include Ochs’s sensor head. The Examiner respectfully disagrees and notes that Ochs describes sensor unit (312), monitor (314), and monitor (326) that are all in separate enclosures (see Figure 3). Ochs further describes that the sensor unit and monitors may communicate wirelessly (see [0066]) via a communications interface that includes one or more transceivers (see [0062]). In order for sensor unit and monitors to be able to communicate wirelessly, it is necessary and inherent for each to include a transceiver. Moreover, Ochs describes processing units that can be separate components, combined in a single component, and/or divided over multiple components (see [0063]). Thus, Ochs reasonably maps to the claim limitations “a first transceiver within the first enclosure” and “wirelessly coupling the oximeter sensor to a system unit contained within a second enclosure that is separate from the first enclosure via a second transceiver of the system unit that is within the second enclosure wherein the second transceiver communicates with the first transceiver through a wireless communication connection passing from the first transceiver through the first enclosure and the second enclosure to the second transceiver”.
Conclusion
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 DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEVIN B HENSON/ Primary Examiner, Art Unit 3791