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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/13/2026 has been entered.
Applicant’s amendments and remarks filed on 02/13/2026 have been fully considered.
Claims 1-20 are pending for examination.
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.
Claims 1, 3-8, 10, 12, 14-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jain et al. (USPGPUB 2021/0236844 – applicant cited) in view of Lisogurski et al. (USPGPUB 2013/0324809). In regard to claim 1, Jain discloses a system for determining levels or concentrations of a substance in a patient's skin based on an optical property of the substance (Figs. 1-5 and associated descriptions), comprising: a computing device comprising a memory, a processor, and a software application stored in the memory of the computing device and configured to run on the processor of the computing device (Fig. 2 and associated descriptions; cellular telephone (cellphone)/ tablet computer… application program (“app”) that can be downloaded and run on the devices, [0041]. It is inherent that cellphone/ tablet computer has a memory and a processor), [0041]); and a module in communication with the computing device and separated and detached from the computing device (element 10, Fig. 2 and associated descriptions), said module comprising: a data communication capability, wherein the data includes voltage, current, light intensity and/or wavelength information (data or results associated with the optical elements 16/18 and communication capability with the local processor 28, Fig. 2 and associated descriptions); a display screen (elements 20, Fig. 2 and associated descriptions); one or more light sources that provide light which penetrates the patient's skin to a subcutaneous level (elements 16/16’/16’’, Figs. 2-3 and associated descriptions; skin, abstract; [0024]; [0030]); multiple optical pathways that transmit the light from the one or more light sources to two or more areas of the patient's skin, which penetrates the patient's skin to the subcutaneous level and is then reflected and scattered to two or more light sensors that detect the reflected and scattered light originating from the one or more light sources (areas and associated optical pathways under/ between elements 16’/16’’ and sensors 18/18’/18’’, Figs. 2-3 and associated descriptions; [0030-0032]); and a power source (element 38, Fig. 2 and associated descriptions); wherein the module determines the levels or concentrations of the substance in the patient's skin/ a standard numerical reading of the levels or concentrations of the substance in the patient's skin based on a measurement of voltage, current, light intensity, or wavelength from the two or more light sensors (bilirubin level, abstract; [0006-0008]; [0035-0036]; Fig. 5 and associated descriptions) and is configured to transmit the to the computer, via a wireless or a wired connection, the determined bilirubin level readings ([0041]).
Jain does not specifically disclose the module is configured to transmit to the computing device, via a wireless or a wired connection, the data including voltage, current, light intensity and/or wavelength information obtained by the two or more light sensors, and wherein the software application of the computing device is configured to determine the levels or concentrations of the substance in the patient's skin based on the data including voltage, current, light intensity, and/or wavelength from obtained by the two or more light sensors and transmitted by the module and the standard numerical reading of the levels or concentrations of the substance in the patient's skin, as determined by the computing device, is sent from the computing device to the module for display on the display screen of the module.
Lisogurski teaches an optical physiological sensor system (Figs. 1 and 3 associated descriptions) comprises a sensor/ local module (elements 100 or 312/314, Figs. 1 and 3 and associated descriptions) including optical sensor elements (elements 130/140 and/or 316/318, Figs. 1 and 3 and associated descriptions) configured to generate data including voltage, current, light intensity and/or wavelength information of optical information reflected by the subject’s tissue obtained by the sensors elements (detected optical data associated with voltage, current, light intensity and/or wavelength from detectors 140/318, Figs. 1 and 3 and associated descriptions; optical information reflected by the subject’s tissue, [0094]) and a remote computing equipment (element 326, Fig. 3 and associated descriptions; or processing equipment remote to the system, [0106] and [0129]) configured to receive data from the local sensor/ local module via wired or wireless communication (cables 332/334 or wireless communication, Fig. 3 and associated descriptions; [0099]) wherein the standard numerical reading of the levels or concentrations of the substance in the patient's skin (physiological parameters/ values derived from the optical detections associated with pulse rate, blood pressure, blood oxygen saturation (e.g., arterial, venous, or both), hemoglobin concentration (e.g., oxygenated, deoxygenated, and/or total), any other suitable physiological parameters, or any combination thereof, [0095]), as determined by the remote computing device, is sent from the remote computing device to the sensor/ local module for display on the display screen of the sensor/ local module (element 326, Fig. 3 and associated descriptions; or “processing equipment remote to the system may be used to determine physiological parameters. The system may display the determined physiological parameter using a local display (e.g., display 320 of FIG. 3)”, [0106] and [0129]; the calculations/ determinations can be performed by an operating system and one or more applications or software applications for the detected optical information, [0086]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the data communication and signal processing configuration of local processing and local/ remote display (Jain) with the communication and signal processing configuration of remote processing and local/ remote display as taught by Lisogurski to yield predictable results, since both devices are physiological/ optical systems and one of ordinary skill in the art would have recognized that the configuration as taught by Lisogurski is an alternative equivalent configuration for data communication and signal processing for local display of the calculated physiological parameters/ values and requires significantly less processing power at the sensor/ local module. The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.), KSR, 550, U.S. at 417.
In regard to claim 3, Jain as modified by Lisogurski discloses the one or more light sources are configured to emit blue and green wavelength light ([0031] of Jain).
In regard to claim 4, Jain as modified by Lisogurski discloses the one or more light sources are configured to emit white light (polychromatic probe light, [0031] of Jain; it is evidenced by Dobson et al., USPN 6,466,807 – cited in previous action, that polychromatic light is white light), and wherein the module further comprises two or more photodiodes or light filters to separate the white light reflected and scattered from the patient's skin into two or more wavelengths of light (bandpass filter(s) and associated photodetectors for detecting green/blue lights, [0031] of Jain).
In regard to claim 5, Jain as modified by Lisogurski discloses the two or more photodiodes or light filters are configured to separate the white light reflected and scattered from the patient's skin into blue and green wavelength light (referring to claim 4 above; [0031] of Jain).
In regard to claim 6, Jain as modified by Lisogurski discloses the two or more photodiodes or light filters are configured to separate the white light reflected and scattered from the patient's skin into two or more wavelengths of light (referring to claims 4-5 above; [0031] of Jain) to determine the levels or concentrations of one or more of a bodily fluid, a body product, a drug marked for a color marker, a drug containing a color marker, a biologic marked for a color marker, and a biologic containing a color marker (body product/ bilirubin, [0035]; Fig. 5 and associated descriptions of Jain).
In regard to claim 7, Jain as modified by Lisogurski discloses the substance is bilirubin (bilirubin, abstract and [0035]; Fig. 5 and associated descriptions of Jain).
In regard to claim 8, Jain as modified by Lisogurski discloses the substance is a bodily fluid, a body product, a drug marked for a color marker, a drug containing a color marker, a biologic marked for a color marker, or a biologic containing a color marker (body product/ bilirubin, [0035]; Fig. 5 and associated descriptions of Jain).
In regard to claim 10, Jain as modified by Lisogurski discloses the power source is a battery or a wired power source (battery/ wired design, [0041] of Jain).
In regard to claim 12, Jain as modified by Lisogurski discloses the software application is configured to calculate light intensity of two or more wavelengths of light detected by the two or more light sensors ([0035]; Fig. 5 and associated descriptions of Jain).
In regard to claim 14, Jain as modified by Lisogurski discloses the software application is configured to calculate and transmit or display the levels or concentrations of the substance in the patient's skin to a recipient, and wherein the recipient is the patient, a user of the system, a parent, a caregiver, one or more healthcare providers, and/or a secure website (Fig. 2 and associated descriptions; medical professional/ doctor/ nurse, [0033] of Jain; website, [0106] and [0129] of Lisogurski).
In regard to claim 15, Jain as modified by Lisogurski discloses the software application is configured to track a history of results associated with the levels or concentrations of the substance in the patient's skin, the history of results including both current results and prior results ([0038] of Jain).
In regard to claim 16, Jain as modified by Lisogurski discloses the software application is configured to provide a history of increases or decreases associated with the history of results (both increase or decrease of the level would be included in the trend, [0038] of Jain).
In regard to claim 17, Jain as modified by Lisogurski discloses the software is configured to include decision support to the patient, a user of the system, a parent, a caregiver, one or more healthcare providers, and/or a secure website based on the history of results compared to clinical standards (medical professional/ doctor/ nurse, [0033]; trend and safe bilirubin level, [0038] of Jain; it is noted that the trend includes multiple values that were current/ real-time values in the past. Each message/ alarm associated with the comparison to the safe bilirubin level in the trend provides “decision support” to the medical professional).
In regard to claim 19, Jain as modified by Lisogurski discloses the computing device is a smartphone, a tablet, a laptop computer, or a desktop computer ([0041] of Jain; element 326, Fig. 3 and associated descriptions of Lisogurski).
In regard to claim 20, Jain as modified by Lisogurski discloses the data communication capability includes BLUETOOTH or other wireless communication (Bluetooth/ WiFi, [0041] of Jain; Bluetooth/ WiFi, [0088] of Lisogurski).
Claims 2 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Jain and Lisogurski as applied to claims 1, 3-8, 10, 12, 14-17, and 19-20 above, and further in view of Mannheimer (USPN 5,524,617, hereinafter Mannheimer ‘617 – cited in previous action). In regard to claims 2 and 9, Jain as modified by Lisogurski discloses the one or more light sources include two or more light sources configured to emit different wavelengths of light that penetrate the patient's skin to a subcutaneous level in the two or more areas (referring to claim 1 above); or the one or more light sources are configured to emit different wavelengths of light to determine the levels or concentrations of one or more of a bodily fluid, a body product, a drug marked for a color marker, a drug containing a color marker, a biologic marked for a color marker, and a biologic containing a color marker (referring to claims 6-7 above) but does not specifically disclose the one or more light sources are configured to illuminate sequentially at multiple points in time in rapid succession.
Mannheimer ‘617 teaches an optical tissue monitoring device (Figs. 1-5 and associated descriptions) comprises at least two detectors (elements 20 and 24, Fig. 4 and associated descriptions) and at least two emitters (element 16, Fig. 4 and associated descriptions; red and infrared LED's 16 , Col 6 lines 29-48) being driven sequentially at multiple points in time in rapid succession (two wavelength driver 34 alternately turn on the red and infrared LED's 16 at a desired chop frequency (e.g. 1,600 hz), Col 6 lines 29-48; Figs. 4-5 and associated descriptions).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the driving and detecting configuration(s) (Jain as modified by Lisogurski) with the driving and detecting configuration(s) and associated elements/ functions as taught by Mannheimer to yield predictable results, since both device are optical sensing systems utilizing two wavelengths and multiple emitters/ detectors and one of ordinary skill in the art would have recognized that the driving and detecting configuration as taught by Mannheimer ‘617 is an alternative equivalent configuration for obtaining reflection data of two wavelengths from the skin (see Mannheimer). The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.), KSR, 550, U.S. at 417.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Jain and Lisogurski as applied to claims 1, 3-8, 10, 12, 14-17, and 19-20 above, in view of Clemente et al. (USPGPUB 2016/0012610 – applicant cited), and further in view of Brumback et al. (USPGPUB 2014/0142403). In regard to claim 11, Jain as modified by Lisogurski discloses all the claimed limitations except an ambient light sensor, and wherein the software application is configured to account for light intensity of ambient light measured from the ambient light sensor in calculating a net light intensity of light reflected and scattered from the patient's skin.
Clemente teaches an optical bilirubin monitoring device (Figs. 2A-2F and associated descriptions) comprises an ambient light sensor disposed near the detection area (element 2h, Fig. 2B and associated descriptions; [0030]; [0032]; claim 6), and wherein the software application is configured to account for light intensity of ambient light measured from the ambient light sensor in calculating a net light intensity of light reflected and scattered from the patient's skin (Fig. 2B and associated descriptions; [0030]; [0032]; claim 6).
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 system (Jain as modified by Lisogurski) to incorporate the ambient light sensor and associated functions/elements as taught by Clemente, since both devices are optical bilirubin monitoring systems and one of ordinary skill in the art would have recognized that environmental/ ambient light reduces the accuracy of the measurements and the ambient light sensor facilitates detection and removal of the noise (see Clemente). The rationale would have been to obtain more accurate optical measurements.
Jain as modified by Lisogurski and Clemente discloses all the claimed limitation except the module comprises an ambient light sensor.
Brumback teaches a wearable biometric monitoring device/ module (Figs. 1-8 and associated descriptions) comprises an ambient light sensor (element 110, Fig. 1 and associated descriptions; ambient light sensor, [0024]) and a wireless connection (e.g. Bluetooth) … Indirect communication refers to the transmission of data between a first device and a secondary device with the aid of one or multiple intermediary third devices which relay the data ([0051]) and a secondary device such as a computer or smart phone that communicates with the device wirelessly (]0052]).
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 system (Jain as modified by Lisogurski and Clemente) to incorporate the ambient light sensor in the module, since both modules are wearable physiological monitoring devices and one of ordinary skill in the art would have recognized that disposing ambient light sensor in the module facilitate detecting ambient light information near the module. The rationale would have been to obtain ambient light information near the measurement site.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Jain and Lisogurski as applied to claims 1, 3-8, 10, 12, 14-17, and 19-20 above, and further in view of Rastegar et al. (USPGPUB 2013/0296667 – cited in previous action). In regard to claim 13, Jain as modified by Lisogurski discloses all the claimed limitations except the software application is configured to register an identity of and relevant contact information for the patient, a user of the system, a parent, a caregiver, one or more healthcare providers, and/or a secure website.
Rastegar teaches a sensor systems (Figs. 1-3 and associated descriptions) comprises a computing device (cellphone 302, Fig. 3 and associated descriptions) with a software application (element 304, Fig. 3 and associated descriptions) configured to register an identity of and relevant contact information for the patient, a user of the system, a parent, a caregiver, one or more healthcare providers, and/or a secure website ([0033]).
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 system (Jain as modified by Lisogurski) to incorporate the registration information as taught by Rastegar, since both devices are cellphone based medical systems and one of ordinary skill in the art would have recognized that the identity of patient/ user/ personal physician and associated emergency contact information facilitate emergency contacting/ reporting the medical condition (see Rastegar). The rationale would have been to register emergency contact information for the patient/ user.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Jain and Lisogurski as applied to claims 1, 3-8, 10, 12, 14-17, and 19-20 above, and further in view of Mannheimer et al. (USPN 8,352,004, hereinafter Mannheimer ‘004 – cited in previous action). In regard to claim 18, Jain as modified by Lisogurski discloses all the claimed limitations except a skin sensor located on the module at a region configured to contact the patient's skin, the skin sensor detecting tissue proximity or pressure.
Mannheimer ‘004 teaches an optical sensor (Figs. 1 and 10-11 and associated descriptions) comprises a skin sensor located on the module at a region configured to contact the patient's skin, the skin sensor detecting tissue proximity or pressure (element 12C, Fig. 4 and associated descriptions; strain gauge sensor/ pressure, Col 5 lines 38-54).
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 system (Jain as modified by Lisogurski) to incorporate the pressure sensor and associated functions/ elements as taught by Mannheimer ‘004, since both devices are optical sensing systems and one of ordinary skill in the art would have recognized that the strain gauge sensor facilitates detection of “sensor on” or “sensor off” based on the detected signal (see Mannheimer ‘004). The rationale would have been to detect whether the device is properly contact the measuring site for optical sensing.
Response to Arguments
Applicant’s amendment and argument with respect to claim 1 filed on 02/13/2026 have been fully considered but they are deemed to be moot in views of the new grounds of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHU CHUAN LIU whose telephone number is (571)270-5507. The examiner can normally be reached M-Th (6am-6pm).
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791