DETAILED ACTION
Claims 1-24 are hereby the present claims under consideration.
Examiner’s Note: all references to Applicant’s specification are made using the paragraph numbers assigned in the US publication of the present application US 20250311948 A1.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-4, 7-9, 12, and 19-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites “the instructions further direct the processor to detect a physical configuration of the substrate” but it is unclear how the processor makes such a detection. In particular, it is unclear through what mechanism the physical configuration of the substrate is detected. It would seem that a processor is incapable of making such a detection without some form of sensor, input, or other indicator to provide it with a signal to make the detection. For the purposes of this examination, the limitation is interpreted as any mechanism through which a processor may determine a physical configuration of a substrate. This rejection and interpretation are further applied to the similar limitations of claim 4.
Claim 3 recites “wherein detecting the one or more detectors of the substrate is based on the physical configuration” but it is unclear if the “detecting of the one or more detectors” is the same as, related to, or different from “identify a type of the one or more detectors of the substrate” of claim 1. It is unclear if “detecting” the detectors is a different operation than identifying the types of the detectors. For the purposes of this examination, these limitations will be interpreted as referring to the same process of identifying the detector types. This rejection and interpretation are further applied to the similar limitations of claim 4.
Claim 7 recites “adjusting an environmental property” but it is unclear how a processor carries out this feedback action. In particular, the transmitting of an alarm or activating of a separate feedback device are operations readily performed by a standard processor. However the recited action of adjusting an environmental property is not an action that appears to be capable of being carried out by a processor. In particular, it would seem that the processor would be required to control an external device in order to effect a desired change. The present claim language indicates that the processor itself is performing the adjustment and it is unclear how this adjustment could be carried out using a processor. For the purposes of this examination, the limitation is interpreted as the processor controlling a separate device to perform an environmental adjustment. This rejection and interpretation are further applied to the similar limitations of claim 19.
Claims 8-9 are rejected by virtue of their dependency on claim 7
Claims 20-21 are rejected by virtue of their dependency on claim 19
Claim 12 recites that the system further includes “a second electronics module communicatively and removably coupled to the substrate”. Thus claim 12 appears to indicate that both the first and second electronics modules are coupled to the substrate. However, each of these modules comprise the same elements and carry out the same function. It is unclear if the claim is intended to convey that the substrate is connected to two electronics modules, where each perform the same function at the same time, or if the claim is intended to convey the mere presence of a second electronics module in the system but not that the second electronics module is connected to the substrate at the same time as the electronics module of claim 1. For the purposes of this examination, the limitation will be interpreted as requiring the presence of the second electronics module but not requiring the substrate to be attached to two electronics modules at the same time.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1-2, 5-8, 10-12, and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Li US Patent Application Publication Number US 20110112379 A1 hereinafter Li.
Regarding claim 1, Li discloses An adaptable system (Abstract) comprising:
a substrate comprising one or more detectors capable of detecting one or more biometric properties (Paragraphs 0032-0034: the sensor array having a plurality of sensor elements on the flexible sheet, the sensor elements may include detectors); and
an electronics module communicatively and removably coupled to the substrate (Paragraphs 0034 and 0041: the monitor coupled to the sensor arrays; The connection being removable is at least suggested by Fig. 1b which illustrates the sensor arrays (12 and 13) connected to the monitor (14) through a cable (24) and that cable is seemingly plugged into a port on the monitor) and comprising:
a processor (Paragraph 0052: monitor may include a processor);
a memory device (Paragraph 0052: monitor may include memory);
an energy storage device configured to power the substrate and the electronics module (Paragraph 0043: the monitor may be powered by a battery; Paragraph 0041: the sensor arrays may draw power from the monitor); and
instructions stored on the memory device that (Paragraph 0052: the software), when executed, direct the processor to:
identify a type of the one or more detectors of the substrate (Paragraphs 0050-0052 and 0056: the processor received information from the encoder of the substrate such as the type of sensors and processes the data to determine the measurement type, or what physiological parameter is being measured); and
process a signal from the identified one or more detectors to calculate one or more biometric parameters (Paragraphs 0055: the processor determined the patient’s physiological parameters).
Regarding claim 2, Li teaches the adaptable system of claim 1. Li further teaches the system wherein the one or more detectors comprise optical detectors (Paragraphs 0033 and 0038: the emitters and detectors for producing and receiving light.).
Regarding claim 5, Li teaches the adaptable system of claim 1. Li further teaches the system wherein, the one or more detectors comprise one or more of thermal detectors, mechanical detectors, electrophysiological detectors, biochemical detectors, or combinations thereof (Paragraphs 0031-0033: the sensors may be a variety of types such as electrode, or electrophysiological, sensors and/or temperature sensors along with any other type of physiological measurement sensor ).
Regarding claim 6, Li teaches the adaptable system of claim 1. Li further teaches the system wherein the instructions further direct the processor to: perform one or more first feedback actions based on the one or more biometric parameters (Paragraphs 0041-0042: the system includes a display for displaying the determined data and an audible alarm for generating an alert if the patient parameters are not within predefined normal ranges.).
Regarding claim 7, Li teaches the adaptable system of claim 6. Li further teaches the system wherein the one or more first feedback actions comprise one or more of transmitting an alarm, activating a feedback device, adjusting an environmental property, or combinations thereof (Paragraphs 0041-0042: the system includes a display for displaying the determined data and an audible alarm for generating an alert if the patient parameters are not within predefined normal ranges.).
Regarding claim 8, Li teaches the adaptable system of claim 7. Li further teaches the system wherein the feedback device comprises one or more of a display, a switch, a sensor, an audible feedback device, a haptic feedback device, a color-based feedback device, a fragrance-based feedback device, a tactile feedback device, or combinations thereof (Paragraphs 0041-0042: the system includes a display for displaying the determined data and an audible alarm for generating an alert if the patient parameters are not within predefined normal ranges).
Regarding claim 10, Li teaches the adaptable system of claim 1. Li further teaches the system wherein the substrate is a flexible substrate (Paragraph 0032: the flexible sheet).
Regarding claim 11, Li teaches the adaptable system of claim 10. Li further teaches the system wherein the flexible substrate is configured to conform to at least a portion of biological tissue (Paragraph 0032: the flexible sheet is worn by the patient. This limitation is considered to at least suggest the sheet conforms to the part of the patient to which it is attached).
Regarding claim 12, Li teaches the adaptable system of claim 1. Li fails to further disclose the system further comprising: a second electronics module communicatively and removably coupled to the substrate and comprising: a second processor; a second memory device; a second energy storage device configured to power the substrate and the second electronics module; and second instructions stored on the second memory device that, when executed, direct the second processor to: identify a type of the one or more detectors of the substrate; and process a second signal from the identified one or more detectors to calculate one or more second biometric parameters.
Li does teach the electronics module of claim 1. The second electronics module of claim 12 requires all the same components and functions as the electronics module of claim 1 and is thus considered a duplicate electronics module. The second electronics module does not perform any function or require any component not already also performed by the electronics module of claim 1. Thus the second electronics module is considered to be an obvious variation of Li as it is a mere duplication of parts that does not produce a surprising technical effect and per MPEP § 2144.04-VI-B. The second electronics module does not produce a new or unexpected result as it is a mere copy of the electronics module of claim 1 and is thus considered to be an obvious variation of Li.
Regarding claim 14, Li teaches an electronics module (Abstract; Paragraphs 0032-0033: the sensor array may include a processor and memory and perform the parameter calculations itself) comprising:
one or more detectors capable of detecting one or more biometric properties (Paragraphs 0032-0033: the various sensor types);
a processor (Paragraph 0032: the sensor array may include a processor);
a memory device (Paragraph 0032: the sensor array may include a memory);
an energy storage device configured to power the electronics module (Paragraph 0034: the sensor array may include its own battery); and
instructions stored on the memory device that, when executed, direct the processor (Paragraphs 0032: the processor; Paragraph 0055: the algorithms used to generate physiological parameters that would be executed on the sensor array of the embodiment where the sensor array performs the calculations itself) to:
identify a type of the one or more detectors; and process a signal from the identified one or more detectors to calculate one or more biometric parameters (Paragraphs 0032-0033: the sensor array itself may perform the calculations itself and includes various types of sensors for determining different parameters. The teachings of the sensor array performing the parameter calculations itself in combination with the plurality of sensor types present on the array are considered sufficient to render the limitation of “identifying a type of the one or more detectors” as obvious because the processor on the sensor array must know the type of signal being received and how to process it to provide the recited physiological parameters. Thus the processor is considered to “identify a type of the one or more detectors” wherever it receives a signal as it must know what type of sensor the signal originates from to perform the appropriate processing into a physiological parameter).
Regarding claim 15, Li teaches the module of claim 14. Li further teaches the module wherein the one or more detectors comprise optical detectors (Paragraphs 0032-0033: the red and infrared emitters and detectors).
Regarding claim 16, Li teaches the module of claim 15. Li further teaches the module further comprising: a first light source capable of emitting a first set of wavelengths of red or near- infrared light, wherein: the one or more detectors are further capable of detecting the first set of wavelengths and are mounted on the electronics module at a first distance from the first light source (Paragraphs 0032-0033 and 0038: the red and infrared emitters and detectors).
Regarding claim 17, Li teaches the module of claim 14. Li further teaches the module wherein the one or more detectors comprise one or more of thermal detectors, mechanical detectors, electrophysiological detectors, biochemical detectors, or combinations thereof (Paragraphs 0031-0033: the sensors may be a variety of types such as electrode, or electrophysiological, sensors and/or temperature sensors along with any other type of physiological measurement sensor.
Regarding claim 18, Li teaches the module of claim 14. Li further teaches the module wherein the instructions further direct the processor to: perform one or more first feedback actions based on the one or more biometric parameters (Paragraph 0033: the results of the calculations may be passed to a monitor. The transmission of data is considered a feedback action and is performed upon such data being detected and is thus “based on” the biometric parameters. Additionally, paragraphs 0041-0042 further teach the presence of a display for displaying the determined data and an audible alarm for generating an alert if the patient parameters are not within predefined normal ranges. An obvious variation of Li would be to implement the audible alarm and/or display into the sensor array itself in the embodiment where the sensor array is used for the determination of parameter rather than only collecting data. Such a variation would be obvious because it is a mere rearrangement of parts. The display and audible alarm still perform their intended function but are simply located on the sensor array itself where data is being locally processed rather than in a secondary location. Such a variation would not produce a surprising technical effect as all components are used for the same purpose as previously indicated. They are simply in different locations).
Regarding claim 19, Li teaches the module of claim 18. Li further teaches the module wherein the one or more first feedback actions comprise one or more of transmitting an alarm, activating a feedback device, adjusting an environmental property, or combinations thereof (Paragraphs 0033-0034: the results of the calculations may be passed to a monitor; The transmission of data is considered a feedback action and constitutes an activation of a feedback device (the wireless transmission circuitry) when data is being detected and is thus “based on” the biometric parameters. Additionally, paragraphs 0041-0042 further teach the presence of a display for displaying the determined data and an audible alarm for generating an alert if the patient parameters are not within predefined normal ranges. An obvious variation of Li would be to implement the audible alarm and/or display into the sensor array itself in the embodiment where the sensor array is used for the determination of parameter rather than only collecting data. Such a variation would be obvious because it is a mere rearrangement of parts. The display and audible alarm still perform their intended function but are simply located on the sensor array itself where data is being locally processed rather than in a secondary location. Such a variation would not produce a surprising technical effect as all components are used for the same purpose as previously indicated. They are simply in different location).
Regarding claim 20, Li teaches the module of claim 19. An obvious variation of Li further teaches the module wherein the feedback device comprises one or more of a display, a switch, a sensor, an audible feedback device, a haptic feedback device, a color- based feedback device, a fragrance-based feedback device, a tactile feedback device, or combinations thereof
Li teaches the use of a display and audible alarm for delivering feedback based on the measured parameters in paragraphs 0041-0042. However these elements are recited as being present in the monitor rather than the sensor array itself. An obvious variation of Li would be to implement the audible alarm and/or display into the sensor array itself in the embodiment where the sensor array is used for the determination of parameter rather than only collecting data. Such a variation would be obvious because it is a mere rearrangement of parts. The display and audible alarm still perform their intended function but are simply located on the sensor array itself where data is being locally processed rather than in a secondary location. Such a variation would not produce a surprising technical effect as all components are used for the same purpose as previously indicated. They are simply in different location
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Li US Patent Application Publication Number US 20110112379 A1 hereinafter Li as applied to claim 2 above and further in view of Shemwell US Patent Number US 6095974 A hereinafter Shemwell in view of Silveira US Patent Application Publication Number US 20150230743 A1 hereinafter Silveira.
Regarding claim 3, Li teaches the adaptable system of claim 2. Li further teaches the system wherein:
the one or more detectors are capable of detecting a first set of wavelengths and are mounted on the substrate at a first distance from a first light source (Paragraphs 0033, 0035, 0038, and 0049: the one or more detectors for receiving one or more wavelengths of light; Each of the sensors may be at the same or different distances from each other; Fig. 1a );
Li further teaches the presence of an encoder on the substrate. The encoder stores information relating to the sensor array such as the type of sensors, the wavelengths utilized by the emitters and what location the sensor array is intended to be placed at (Paragraphs 0050-0051). Li teaches that the wavelengths utilized by the sensor may depend of the location of the sensor on the body (Paragraph 0047). Li further teaches that the sensor array may take any shape may have the sensors laid out in any suitable geometry with equal or unequal spacing (Paragraph 0035).
Li fails to further teach the system wherein the electronics module further comprises the first light source capable of emitting the first set of wavelengths of red or near-infrared light; and the instructions further direct the processor to: detect a physical configuration of the substrate; select, based on the physical configuration, the first set of wavelengths; and select, based on the physical configuration, the first distance from the first light source, wherein detecting the one or more detectors of the substrate is based on the physical configuration.
Shemwell teaches an apparatus for transferring two frequencies of electromagnetic energy to and from a portion of a living body for the purpose of blood oxygen saturation measurements (Abstract). Thus, Shemwell falls within the same field of endeavor as Applicant’s invention.
Shemwell teaches a detachable probe for transmitting laser light to a patient. The probe comprises a flexible substrate for holding the emitting and receiving fiber optics (Col 8 lines 20-31). Shemwell teaches that a fiber optic connection may be used to transmit light to a probe for emission and the probe may contain the photodetector to send received absorption information back to the measurement instrument (Col 10 line 63 – Col 11 line 11: Fig. 4). The light sources in the measuring instrument may be red or infrared sources (Col 4 lines 30-54).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to configure the system of Li to utilize light sources in the monitor that transmit light via fiber optics to the emitter areas of the patch as taught by Shemwell because Shemwell teaches that such a configuration may reduce the cost of the patches and allows an operator to throw away the portion of the system that contacts the patient, or the measurement patch, while keeping costs low (Col 5 lines 18-46).
Li in view of Shemwell fails to further teach the system wherein the instructions further direct the processor to: detect a physical configuration of the substrate; select, based on the physical configuration, the first set of wavelengths; and select, based on the physical configuration, the first distance from the first light source, wherein detecting the one or more detectors of the substrate is based on the physical configuration.
Silveira teaches a medical sensor includes a first set of optical components configured to obtain a first set of signals for determining a first regional oxygen saturation measurement (Abstract). Thus, Silveira falls within the same field of endeavor as Applicant’s invention.
Silveira teaches a sensor patch which may include an encoder which stores information related to the sensor patch including the configuration or number and spacing of emitter and detectors (Paragraphs 0036-0038).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to configure the system of Li in view of Shemwell to further have the encoders of Li include information relating to the configuration and/or spacing of sensors on the substrate as taught by Silveira, because such configuration information may be used by the monitor to select appropriate processing and calibration algorithms for the signals received from the sensor patch (Silveira: Paragraphs 0036-0038).
Thus, Li in view of Shemwell further in view of Silveira teaches that the encoder in the patch of Li may include information relating to the physical layout of sensors on the patch (Silveira: Paragraphs 0036-0038). This information is received by the monitor which detects the physical configuration including the distances from the emitter to each of the light sources. The encoder further includes information relating to what wavelengths of light will be utilized by the patch (Li: Paragraphs 0050-0051). The modified system utilizes a light source in the monitor to transmit the appropriate wavelengths of light to the emitter site (Shemwell: Col 10 line 63 – Col 11 line 11: Fig. 4). Therefore, the sensor patch conveys the configuration of the sensors and the required light wavelengths for the particular configuration, sensor location, and parameter type being measured to the monitor. The monitor then supplies the appropriate wavelengths according to the supplied information.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Li US Patent Application Publication Number US 20110112379 A1 hereinafter Li as applied to claim 2 above and further in view of Silveira US Patent Application Publication Number US 20150230743 A1 hereinafter Silveira.
Regarding claim 4, Li teaches the adaptable system of claim 2. Li further teaches the system wherein: the substrate further comprises a first light source capable of emitting a first set of wavelengths of red or near-infrared light (Paragraphs 0032-0033, 0038, and 0048: the substrate includes emitters which may emit red and/or infrared light); the one or more detectors are capable of detecting the first set of wavelengths and are mounted on the substrate at a first distance from the first light source (Paragraphs 0032-0033, 0035, and 0038: the emitters and detectors on the substrate may be mounted at various distances; Fig. 1a).
Li fails to further teach the system wherein the instructions further direct the processor to: detect a physical configuration of the substrate, wherein detecting the one or more detectors of the substrate is based on the physical configuration.
Silveira teaches a sensor patch which may include an encoder which stores information related to the sensor patch including the configuration or number and spacing of emitter and detectors (Paragraphs 0036-0038).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to configure the system of Li to further have the encoders of Li include information relating to the configuration and/or spacing of sensors on the substrate as taught by Silveira, because such configuration information may be used by the monitor to select appropriate processing and calibration algorithms for the signals received from the sensor patch (Silveira: Paragraphs 0036-0038).
Claims 9 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Li US Patent Application Publication Number US 20110112379 A1 hereinafter Li as applied to claims 7 and 19 above and further in view of Lee US Patent Application Publication Number US 20070083079 A1 hereinafter Lee.
Regarding claims 9 and 21, Li teaches the adaptable system and module of claims 7 and 19 respectively. Li fails to further teach the system wherein the environmental property comprises one or more of temperature, pressure, chemical composition, sound, light, motion, or combinations thereof.
Lee teaches a method and apparatus to induce sound sleep and waking, selecting a protocol to control a sound sleep and waking environment depending on a sleep type selected by a user; adjusting the sleep environment of the user according to the selected protocol; determining a sleep state of the user by measuring physiological signals of the user during sleep in the sleep environment (Abstract). Thus, Lee is reasonably pertinent to the problem of physiological monitoring and feedback at hand.
Lee teaches a system which measures physiological signals of a patient to determine a sleep state (Paragraph 0034) and when predetermined variations occur in the physiological signals, an environmental control module performs an adjustment to the environment as feedback (Paragraphs 0038-0039). The environmental control may include adjusting one or more of the room temperature, light levels, sound levels, humidity, aroma, and/or oxygen in the room (Paragraphs 0024, 0033, and 0043; Fig. 1).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to configure the system and/or module of Li to monitor sleep state and be connected with an environmental adjustment feedback unit as taught by Lee because Li already determines the required parameters for sleep state determination (Li: paragraphs 0033 and 0041 :the system determines heart rate and respiration rate) and Lee teaches that such parameters can be used to determine sleep state (Lee: Paragraph: 0034) and configuring the system and module of Li to perform the operations taught by Lee would improve the applicability of the system of Li to a wider range of use cases and monitoring scenarios. Additionally, incorporating the environmental control of Lee into the system and module of Li may allow the system to have greater control of the measurement environment and adjust environmental parameters when possible interference may be occurring.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Li US Patent Application Publication Number US 20110112379 A1 hereinafter Li as applied to claim 1 above and further in view of Silveira US Patent Application Publication Number US 20150230743 A1 hereinafter Silveira in view of Charlton US Patent Application Publication Number US 20080301665 A1 hereinafter Charlton.
Regarding claim 13, Li teaches the adaptable system of claim 1. Li further teaches the system wherein: the electronics module further comprises software and firmware (Paragraphs 0052-0053: the module includes processors and memories as well as software executed thereon), and
Li fails to further disclose the system wherein the instructions further direct the processor to: determine whether the substrate is compatible with the software and firmware; and responsive to determining the substrate is not compatible with the software and/or firmware, the electronics module performs at least one of the following: transmit an alert; and perform an update to the software and/or firmware.
Silveira teaches a sensor patch which may include an encoder which stores information related to the sensor patch including the configuration or number and spacing of emitter and detectors. The encoder may also include an encryption that prevents the substrate from being utilized by a processor that is unable to decode the encryption (Paragraphs 0036-0038).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to configure the system of Li to further have the encoders of Li include information a specific encryption as taught by Silveira, because such an encryption may improve the security or the system and ensure that the substrate is being connected to an appropriate monitor capable of interpreting the signals that will be produced by the sensor substrate.
Li in view of Silveira fails to further disclose the system wherein the instructions further direct the processor to: determine whether the substrate is compatible with the software and firmware; and responsive to determining the substrate is not compatible with the software and/or firmware, the electronics module performs at least one of the following: transmit an alert; and perform an update to the software and/or firmware.
Charlton teaches an architecture that allows individual system components to be developed and tested individually, i.e., as distinct modules, and to be subsequently combined through standardized electrical and communication interfaces. Any combination of these modules can be implemented to form different products that provide any number of functions, such as an integrated system for monitoring a health condition and/or delivering a medication (Abstract). Thus, Charlton is reasonably pertinent to the problem at hand.
Charlton teaches a system which utilizes a common central engine or computing device which operates a plurality of different interchangeable modules. The central engine communicates with the modules but also communicates with an external network for receiving updates to the software and/or firmware of the central module to ensure compatibility. Charlton teaches that certain sensor modules may be incompatible when connected but the central module may receive an update to the software and/or firmware to enable compatibility (Paragraphs 0069-0073).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to configure the system of Li in view of Silveira to include the network update configuration as taught by Charlton because such a configuration would allow the monitor of Li in view of Silveira to perform an update when a substrate is connected that includes an encryption not recognized by the encoder. The inability to decode the encryption, or identification of incompatibility, may be used as a trigger to perform an update as taught by Charlton for the monitor to receive processing algorithms and/or decryption methods that correspond to the attached sensor substrate. Such a combination would ensure that sensor substrates cannot be utilized by monitors that lack the appropriate processing algorithms to produce the parameters intended to be measured by the substrate. This would prevent inaccurate data from being produced and display to patients when a monitor is using an algorithm that is incompatible with the particular substrate connected.
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Li US Patent Application Publication Number US 20110112379 A1 hereinafter Li as applied to claim 1 above and further in view of Wiese US Patent Application Publication Number US 20210045671 A1 hereinafter Wiese in view of Everman US Patent Application Publication Number US 20180310893 A1 hereinafter Everman.
Regarding claim 22, Li teaches a method of calculating one or more biometric parameters (Abstract), the method comprising: mounting at least a portion of the adaptable system of claim 1 (See the above rejection of claim 1) on biological tissue (Paragraph 0039: the sensor array may be mounted to the user’s forehead); and regularly executing the instructions to calculate the one or more biometric parameters (Paragraph 0058: the measurements may be taken continuously or at predefined intervals).
Li further teaches determining user-specific threshold values based on user characteristics (Paragraph 0051) but fails to further disclose a method including: mounting the electronics module on biological tissue; and executing the instructions for a period of time to determine a baseline level associated with the one or more biometric parameters
Wiese teaches a wearable optical device is described for optically detecting parameters of interest within muscle, such as during physical activity or when at rest. The parameters of interest include oxygenation level and/or hemoglobin concentrations in some situations (Abstract). Thus, Wiese falls within the same field of endeavor as Applicant’s invention.
Wiese teaches a control module connected to detector strips. The control module may be mounted on the user (Paragraphs 0101-0102)
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to configure the method of Li to include configuring the monitor of Li to be sized for and capable of mounting on the user as taught by Wiese because attaching the monitor of Li to the user would improve the usability of the system by improving the ability of the patient to move while being monitored since the entire system is located on their person they are not constrained to the range of the wires attaching the sensor array to a monitoring device.
Li in view of Wiese fails to further teach the method including executing the instructions for a period of time to determine a baseline level associated with the one or more biometric parameters.
Everman teaches a system for measuring physiological parameters includes a housing mounted to an exterior body surface of a user. The system includes at least a sensor attached to the housing and contacting the exterior body surface at a locus on a head of the user, the at least a sensor configured to detect at least a physiological parameter and transmit an electrical signal as a result of the detection (Abstract). Thus, Everman falls within the same field of endeavor as Applicant’s invention.
Everman teaches that baseline, or normal, values for a patient may be established by monitoring the physiological parameters of interest for the patient over a period of time or when certain other parameters such as environmental parameters are at a desired level (Paragraphs 0032-0036).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to configure the method of Li in view of Weise to include determining a baseline level for the patient based on the monitored parameters as taught by Everman because Li already contemplates generating user-specific threshold values (Paragraph 0051) and the baseline determination methods of Everman would allow the method to be more adaptable and customizable to fit the particular user’s normal biometric parameters which may reduce the number of false positive or false negative alarms generated.
Regarding claim 23, Li in view of Weise further in view of Everman teaches the method of claim 22. Modified Li further teaches the method further comprising: performing one or more first feedback actions based on the one or more biometric parameters (Paragraph 0041: the generation of an alarm if the patient’s physiological parameters are not within predefined normal ranges).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Li US Patent Application Publication Number US 20110112379 A1 hereinafter Li as applied to claim 1 above and further in view of Everman US Patent Application Publication Number US 20180310893 A1 hereinafter Everman
Regarding claim 24, Li teaches a method of calculating one or more biometric parameters (Abstract), the method comprising: mounting the electronics module of claim 12 (See the above rejection of claim 1) on biological tissue (Paragraph 0039: the sensor array may be mounted to the user’s forehead; Paragraphs 0032-0033: the sensor array may perform the parameter calculations); and regularly executing the instructions to calculate the one or more biometric parameters (Paragraph 0058: the measurements may be taken continuously or at predefined intervals; Paragraphs 0032-0033: the sensor array may perform the parameter calculations).
Li fails to further teach the method including executing the instructions for a period of time to calculate a baseline level associated with the one or more biometric parameters
Everman teaches that baseline, or normal, values for a patient may be established by monitoring the physiological parameters of interest for the patient over a period of time or when certain other parameters such as environmental parameters are at a desired level (Paragraphs 0032-0036).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to configure the method of Li to include determining a baseline level for the patient based on the monitored parameters as taught by Everman because Li already contemplates generating user-specific threshold values (Paragraph 0051) and the baseline determination methods of Everman would allow the method to be more adaptable and customizable to fit the particular user’s normal biometric parameters which may reduce the number of false positive or false negative alarms generated.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW ERIC OGLES whose telephone number is (571)272-7313. The examiner can normally be reached M-F 8:00AM - 5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached on Monday-Friday from 9:00AM – 4:00PM at (571) 272 – 7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
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