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 .
Applicant’s amendments and remarks filed on 05/22/2026 have been fully considered.
Claims 1-9 and 11-21 are pending for examination. Claim 10 is cancelled.
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, 12, 14-17, and 19-21 is/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 – cited in previous action). In regard to claims 1 and 21, 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/ consisting of: 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 for running the app); and a remote, hand-held device in communication with the computing device and separated and detached from the computing device (element 10, Fig. 2 and associated descriptions; it is noted the device 10 can be held by hand and is remote and separated from the computing device, e.g. cellphone or tablet computer, [0041]), said remote, hand-held device comprising: an external data communication capability (element 24, Fig. 2 and associated descriptions; “app communicates with the phototherapy monitoring device 10 via the wireless communication interface 24 (e.g. a Bluetooth and/or WiFi interface)”, [0041]; element 190, [0088]); a display screen for displaying a standard numerical reading (bilirubin level readings/ standard numerical reading of 120 as illustrated in Fig. 2; display the continuously estimated current bilirubin level, [0038]; element 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 remote, hand-held device is configured to transmit to the computing device, 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]; [0035-0038]; 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 remote, hand-held device 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 obtained by the two or more light sensors and transmitted by the remote, hand-held device 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 remote, hand-held device for display on the display screen of the remote, hand-held device.
Lisogurski teaches an optical physiological sensor system (Figs. 1 and 3 associated descriptions) comprises a computing device (processing equipment remote to the system, [0106] and [0129]); a remote, hand-held device (element 100 or combination of elements 314/324/312, Figs. 1 and 3 and associated descriptions; it is noted that the device 100 or combination of elements 314/324/312 is remote to the computing device and can be held by hand ) 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 sensor 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 the computing device (processing equipment, [0106] and [0129]) configured to receive data from the remote, hand-held device via wired or wireless communication (element 190, Fig. 1 and associated descriptions; [0088] or cables 332/334 or wireless communication, Fig. 3 and associated descriptions; [0099]; it is inherent that the processing equipment determines the physiological parameters using the obtained optical information, [0106] and [0129] being wired or wireless transmitted from the remote, hand-held device, since device 100 or combination of elements 314/324/312 comprises wired or wireless communication and the processing equipment cannot perform the determination functions without detected optical data); 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 computing device, is sent from the computing device to the remote, hand-held device for display on the display screen of the remote, hand-held device (displays 184 or 320, Figs. 1 and 3 and associated descriptions; “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 configurations of remote processing (at the hand-held device) and remote display (at the hand-held device) (Jain) with the communication and signal processing configurations of processing (processing equipment remote to the system, [0106] and [0129]) and remote display (at displays 184 or 320 of the hand-held device, Figs. 1 and 3) 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 remote signal processing for display of the calculated physiological parameters/ values at the hand-held device and requires significantly less processing power at the remote, hand-held device. 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 remote, hand-held device 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 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, 12, 14-17, and 19-21 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, 12, 14-17, and 19-21 above, in view of Clemente et al. (USPGPUB 2016/0012610 – applicant cited), and further in view of Brumback et al. (USPGPUB 2014/0142403 – cited in previous action). 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 remote, hand-held device comprises an ambient light sensor.
Brumback teaches a wearable biometric monitoring device (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 remote, hand-held device, since both devices are wearable physiological monitoring devices and one of ordinary skill in the art would have recognized that disposing ambient light sensor in the remote, hand-held device facilitate detecting ambient light information near the remote, hand-held device. 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, 12, 14-17, and 19-21 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 19-21 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 remote, hand-held device 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 device 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 arguments filed on 05/22/2026 have been fully considered but they are not persuasive. In regard to claim 1, applicant alleged that Jain does not teach or suggest “a remote, hand-held device”. In response, Jain discloses this feature. Under the BRI, a hand-held device is interpreted at a device can be held by hand and the “remote” is a relative term which can be defined with respect to a local/ comparable device or location. In the teachings of Jain, the device is interpreted as a device can be held by hand and remote to the cellphone/ tablet computing device (see the rejections above). If the remote, hand-held device is essential to the invention, applicant should consider reciting more structural limitations/ details of the device in the claims.
The applicant further alleged that the combination of Jain and Lisogurski does not teach or suggest the claimed computing device and the “app” running on the device is not performing (1) receiving data including voltage, current, light intensity and/or wavelength information from the remote, hand-held device, (2) determining the relevant substance levels/concentrations based on this data, and (3) transmitting a standard numerical reading of the relevant substance levels/concentrations to the remote, hand-held device for display on the display screen of the remote, hand-held device. In response, the features are taught by the combination of Jain and Lisogurski (see the rejection above). In the teachings of Lisogurski, both “remote, hand-held device” of device 100 or combination of elements 314/324/312, Figs. 1 and 3, have wired or wireless communication capability (see the rejection above) and a processing equipment remote to the system determines physiological parameters based on optical information obtained from the remote, hand-held device (see the rejection above) and the calculations/ determinations can be performed by an operating system and one or more applications or software applications for the detected optical information (see the rejection above; [0086]). As compared to the system of Jain, both systems comprise a computing device (e.g. cellphone/ tablet computer running “app” of Jain; a processing equipment remote to the system and a computer with an operating system and one or more applications or software applications is capable of determining physiological parameters from the detected optical information of Lisogurski), a remote, hand-held device, and wireless communication capability for transmitting data and/or determined physiological parameters/ values (e.g. Bluetooth or WiFi , see both Jain and Lisogurski). One of ordinary skill in the art would have recognized that the computing device as taught by Jain (e.g. cellphone or tablet computer) is capable of running “application(s)/ app(s)” and Lisogurski teaches applications or software applications in a computer with an operation system is capable of determining physiological parameters based on detected optical information and incorporation of calculation(s) or other functions in softwares/ applications are commonly known in the art. The combination of Jain and Lisogurski (see above) is made by substitution of data communication and data processing configurations/ functions to yield predictable results and reduce processing power at the remote, hand-held device (see the rejection above). The combination provides similar function(s) of calculating and displaying the results/ values on the display of the remote, hand-held device which does not change the scope(s) of the teachings of Jain.
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 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
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