DETAILED ACTION
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/29/2025 has been entered.
Claims 2-14 and 16-21 are hereby the present claims under consideration
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.
Claim 18 is 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 18 recites “the surface of a sensor head of the sensor frame” but it is unclear if this limitation is the same as, related to, or different from “the sensor frame comprises: a surface” of claim 17. In particular, the “surface” set forth in claim 17 is a surface of the “sensor frame” rather than the “sensor head” thus the limitation “the surface of a sensor head” lacks sufficient antecedent basis and it is unclear if the surface of the sensor head of claim 18 is the same surface of the sensor frame of claim 17. For the purposes of this examination, the limitations are interpreted as referring to the same surface.
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 2-7, 9-12, 14, 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Talmor US Patent Number US 5851181 A hereinafter Talmor in view of Tunnell US Patent Application Publication Number US 2017/0224220 A1 hereinafter Tunnell and further in view of Drury US Patent Application Publication Number US 2017/0188864 A1 hereinafter Drury.
Regarding claim 2, Talmor discloses a system for determining a physiological parameter using a plurality of noninvasive sensors arranged to interrogate tissue of a patient (Abstract), the system comprising:
first and second noninvasive sensors of the plurality of noninvasive physiological sensors disposed within nonparallel cavities fixed with respect to each other within a sensor frame (Fig. 2 reference 12: the housing having non-parallel cavities, references 18 and 20: the sensors including a camera and spectrometer arranged in the housing; Col 3 line 54- Col 4 line 9: the camera and spectrometer arranged in the housing), wherein the nonparallel cavities have central longitudinal axes that diverge by at least 10 degrees (Col 4 lines 43-65: the camera is disposed at an angle of between 10 and 20 degrees from perpendicular), wherein the first noninvasive sensor is configured to obtain first physiological data from a first tissue region of the patient, and wherein the second noninvasive sensor is configured to obtain second physiological data from a second tissue region of the patient, wherein the first and second tissue regions at least partially overlap in a common volumetric region of the tissue of the patient (Fig. 2: the overlap of the camera field of view with the light guide at the treatment site; Col 3 line 54 – Col 4 line 42: the light guide is within the field of view of the camera); and
a hardware processor (Col 5 lines 34-48: the computer) configured to:
receive a first data signal from the first noninvasive sensor, wherein the first data signal is associated with the first physiological data (Col 5 lines 34-48: the spectrum of light received from the spectrometer);
receive a second data signal from the second noninvasive sensor, wherein the second data signal is associated with second physiological data (Col 5 lines 49-64: the images received from the camera).
Talmor further discloses that the spectroscopy device determines an absorption spectra of the tissue (Col 5 lines 34-48).
Talmor fails to further disclose the system including: determine the physiological parameter based at least in part on the first and second data signals.
Tunnell teaches a fiber-optic probe for multi-modal characterization of a tissue. The fiber optic probe may comprise a first group of fibers associated with a first modality of light. The first group of fibers may comprise a first light delivery fiber and a first light collection fiber. The fiber optic probe may also comprise a second group of fibers associated with at least a second modality of light, the second group of fibers comprising a second light delivery fiber and a second light collection fiber; The fiber optic probe may also comprise a longpass filter positioned distal to the first group of fibers and a lens positioned distal to the filter. The fiber optic probe may also comprise. The fiber optic probe may include the second group of fibers bypassing the filter. The second group of fibers may bypass the filter (Abstract). Thus, Tunnell falls within the same field of endeavor as Applicant's invention.
Tunnell teaches a multi-spectroscopy probe to be placed in contact with the user's skin comprising a plurality of fibers grouped with a source light and at least one respective modality of light (Paragraph 0027). The fiber bundle allows for multiple types of spectroscopy to be performed (Paragraph 0030) Tunnell teaches that the multi-spectroscopic probe may be used to determine a variety of parameters from the interrogated tissue including oxygen saturation (Paragraph 0036).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the spectroscopy probe of Talmor to include the fiber bundle and multiple spectroscopy techniques as taught by Tunnell because the fiber bundle and spectroscopy techniques of taught by Tunnell would allow the system of Talmor to detect a wider variety of tissue parameters and swap between various type of spectroscopic analysis based on the desired use case of the invention thus making the device useful in a wider variety of applications.
Talmor is view of Tunnell fails to further teach the system including: determine the physiological parameter based at least in part on the first and second data signals.
Drury teaches a biosensor array device for physiological status monitoring (Abstract). Thus, Drury falls within the same field of endeavor as Applicant’s invention.
Drury teaches that CCD cameras may be configured to optically detect parameters such as heart rate (Paragraph 0102). Drury further teaches that inputs from various sensor types may be combined to determine physiological parameters (Paragraph 0135). Drury teaches one such combination as a combination of one or more optical sensors which detect heart rate and oxygen saturation in order to generate a PPG signal. Drury further teaches that optical sensors can be configured to detect a variety of different parameters (Paragraph 0113).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the CCD camera of Talmor (Talmor: Col 4 lines 43-65) to detect physiological parameters such as heart rate as taught by Drury and to further configure the system of Talmor in view of Tunnell to determine physiological parameters using a combination of inputs from the different sensors as taught by Drury because configuring the camera of Talmor to detect physiological parameters allows the system to detect a wider variety of parameters which may provide more useful insight into a patient’s condition and configuring the system to determine physiological parameters using a combination of different inputs may improve the accuracy of those determinations since multiple sources of sensor data may be less subject to interference, noise, or other affects that may affect the accuracy of the data and also may allow the device to determine a wider variety of parameters that would otherwise be possible if data from different sensors could not be considered in combination.
Regarding claim 3. Talmor in view of Tunnell further in view of Drury teaches the system of Claim 2. Modified Talmor further teaches the system wherein the sensor frame comprises: a surface configured to contact the tissue of the patient at the common volumetric region (Fig. 2 references 30 and 12: the window and the portion of the housing that contacts the patient; Col 4 lines 25-42: the window extending across the opening).
Regarding claim 4. Talmor in view of Tunnell further in view of Drury teaches the system of Claim 3. Modified Talmor further teaches the system, wherein the surface comprises an area equal to or greater than an area defined by an outer perimeter of the common volumetric region (Fig. 2 references 30 and 12: the window and the portion of the housing that contacts the patient; Col 4 lines 25-42: the window extending across the opening is equal to the area being interrogated and the portion of the housing that surrounds the window).
Regarding claim 5. Talmor in view of Tunnell further in view of Drury teaches the system of Claim 2. Modified Talmor fails to further teach the system further comprising: a third noninvasive sensor disposed within the sensor frame, the third noninvasive sensor configured to obtain third physiological data from a third tissue region of the patient, wherein the first, second, and third tissue regions at least partially overlap in the common volumetric region of the tissue of the patient wherein the hardware processor is further configured to: receive a third data signal from the third noninvasive sensor, wherein the third data signal is associated with the third physiological data, and determine the physiological parameter based at least in part on the third data signal.
Drury teaches a third noninvasive sensor disposed within the sensor frame, the third noninvasive sensor configured to obtain third physiological data from a third tissue region of the patient (Paragraph 0035, Table 2, and 0365: Drury teaches a variety of physiological sensors including motion, contact, temperature, and electrodes. These various sensors may be positioned in a variety of ways), wherein the first, second, and third tissue regions at least partially overlap in the common volumetric region of the tissue of the patient (Paragraphs 0365 and 0368-0369: the sensors may all be present at a common interrogation site) wherein the hardware processor is further configured to: receive a third data signal from the third noninvasive sensor, wherein the third data signal is associated with the third physiological data, and determine the physiological parameter based at least in part on the third data signal (Paragraph 0135, 0365, and 0369: inputs from any number of sensors may be considered in combination to calculate corresponding physiological data).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement one or more of the various sensor types taught by Drury into the system of modified Talmor such that the sensors interrogate the contact area of Talmor because Drury teaches that various sensor types may interrogate the same area (Drury: Paragraphs 0365 and 0368-0369) and further teaches that various sensor inputs may be combined to determine a physiological parameter (Drury: Paragraph 0135) and thus it would be obvious to implement one or more of the sensors taught by Drury such as a temperature sensor, galvanic skin response sensor, and/or pressure sensor into the system of modified Talmor to interrogate or provide measurements from the common tissue site because Drury teaches that these sensor types may be considered in combination with other sensor inputs to determine physiological parameters (Paragraph 0135) and including additional sensors in the system of modified Talmor may provide the system with additional contextual information about the sensor site which may be useful in determining the state of the patient, for compensating other measurement modalities, and/or for determining signal validity or quality as taught by Drury (Drury: Paragraphs 0071 and 0090: skin temperature and galvanic skin response may be used to adjust the wavelength of light used in spectroscopy to improve signal quality; Paragraph 0101: contact-indicating sensors can be used to determine a signal quality for optical sensors)
Regarding claim 6, Talmor in view of Tunnell further in view of Drury teaches the system of Claim 3. Modified Talmor further teaches the system, wherein the first and second noninvasive sensors are configured to simultaneously obtain the first and second physiological data (Col 5 lines 49-64: the camera and spectroscopy system provide data simultaneously).
Modified Talmor is further consider to at least suggest the limitation: while the sensor frame is stationary relative to the tissue in Col 2 lines 23-33 where Talmor states that the system allows treatment of the treatment sight without requiring the light source to be moved while spectral emissions from the treatment site are measured. Talmor does not disclose any mechanism for moving the light source relative to the housing and states that the light source does not move during spectral measurement. Thus, Talmor is considered to at least suggest that the frame and all sensors therein remain stationary relative to the tissue site during measurement.
Regarding claim 7, Talmor in view of Tunnell further in view of Drury teaches the system of Claim 2. Modified Talmor fails to further teach the system, wherein the first and second noninvasive sensors are configured to obtain the first and second physiological data at non-overlapping time intervals.
Drury teaches that biosensors may perform measurements simultaneously, sequentially, or at other times (Paragraph 0369).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the sensors of modified Talmor to obtain data sequentially as taught by Drury because sequential data collection may prevent interference between the different modalities of data collection, and/or is a simple substitution of one known element (simultaneous data acquisition) for another known element (sequential data acquisition) with no surprising technical effect.
Regarding claim 9, Talmor in view of Tunnell further in view of Drury teaches the system of Claim 2. Modified Talmor fails to further teach the system, wherein the first noninvasive sensor comprises a Raman spectroscopy device, wherein the Raman spectroscopy device comprises a Raman lens tube coupled to a sensor head of the sensor frame.
Tunnell teaches a multi-spectroscopy probe to be placed in contact with the user's skin comprising a plurality of fibers grouped with a source light and at least one respective modality of light (Paragraph 0027). Tunnell teaches that the modality of light may include Raman spectroscopy including a lens tube coupled to the sensor head (Paragraphs 0030-0031; Fig. 1B references 114 and 180).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to combine the use of Raman spectroscopy and its associated components as described by Tunnell into the system of modified Talmor because the incorporation of Raman measurement modality as described by Tunnell provides Talmor with an additional optical measurement modality with which to create a more complete physiological picture of the patient
Regarding claims 10 and 11, Talmor in view of Tunnell further in view of Drury teaches the system of Claim 2. Modified Talmor fails to further teach the system, wherein the first noninvasive sensor comprises a pulse oximetry device, wherein the pulse oximetry device comprises an optic fiber bundle; or wherein the first noninvasive sensor comprises a pulse oximetry device, wherein the pulse oximetry device comprises a plurality of optical fibers.
Tunnell teaches a multi-spectroscopy probe to be placed in contact with the user's skin comprising a plurality of fibers grouped with a source light and at least one respective modality of light (Paragraph 0027). The fiber bundle allows for multiple types of spectroscopy to be performed (Paragraph 0030) Tunnell teaches that the multi-spectroscopic probe may be used to determine a variety of parameters from the interrogated tissue including oxygen saturation (Paragraph 0036).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to combine the use of a fiber optic bundle as described by Tunnell into the system of modified Talmor because the incorporation of a fiber optic bundle would allow the modified Talmor to perform multiple types of optical analysis using different configurations of emitting and receiving fibers which would allow the system to accommodate a wider variety of measurement modalities.
Modified Talmor in view of Tunnell fails to further teach the system wherein the first noninvasive sensor comprises a pulse oximetry device, wherein the pulse oximetry device comprises an optic fiber bundle.
Drury teaches the use of optical PPG sensors and blood oxygen sensors (Paragraphs 0035, 0069, 0084, 0365) and further teaches that light transmissive structures such as light pipes may be employed to facilitate transmission of light to and from the user’s body and skin (Paragraph 0073).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the PPG sensors of Drury as part of the optical measurement modalities of modified Talmor in view of Tunnell because the fiber optic bundle of modified Talmor in view of Tunnell permits a variety of optical measurement modalities and incorporating the PPG or pulse oximetry sensing of Drury would provide the system with additional information about the user and the tissue being imaged which may provide additional contextual information to a clinician evaluating the patient and improve patient outcomes.
Regarding claim 12, Talmor in view of Tunnell further in view of Drury teaches the system of Claim 11. Modified Talmor fails to further teach the system, wherein the pulse oximetry device further comprises an emitter coupled to at least a first optic fiber of the plurality of optic fibers and having an emitter sensing region and a detector coupled to at least a second optic fiber of the plurality of optic fibers and having a detector sensing region.
Drury teaches that the PPG sensor is an optical sensor (Paragraphs 0048-0049) and that optical sensors include light emitters and detectors to direct light into and then sample light from the user’s skin in order to determine the associated physiological parameters (Paragraph 0069). Drury further teaches that light pipes may be used to facilitate transportation to and from the light sources and detectors and the user’s skin (Paragraph 0073).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the PPG sensor using a fiber optic bundle of modified Talmor (as presented in the above rejection of claim 11) such that the emitters and detectors of the PG sensor are each coupled to a respective Fiber of the fiber bundle as taught by Drury which teaches that light pipes may facilitate the transportation of optical signals to and from these elements and the user’s skin because the use of light pipes in the fiber optic bundle to transport the optical signals to and from the PPG allows the emitters and detectors to be located away from the measurement site which may reduce the required size of the measurement site and thus the bulk of the senor contact area. Additionally the use of a fiber bundle allows the particular arrangement of emitter and detector fibers to be changed by changing what element is connected to each fiber. This allows the system to measure in multiple configurations and may produce more accurate results. It is further noted that an emitter sensing region and detector sensing region are implicitly taught as the points where the respective fibers contact the user’s skin.
Regarding claim 14, Talmor in view of Tunnell further in view of Drury teaches the system of Claim 2. Modified Talmor fails to further teach the system, wherein the physiological parameter comprises a concentration of blood glucose.
Drury teaches that blood glucose may be determined using one or more optical sensors (Paragraphs 0069 and 0113). Drury further teaches that heart rate measurements may be related to blood glucose levels (Paragraphs 0292 and 0353-0354). Drury teaches that inputs from multiple sensors may be considered in combination to calculate corresponding physiological parameters (Paragraph 0135).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the system of modified Talmor to measure blood glucose using a combination of sensor measurements as taught by Drury because it is a simple substitution of measuring one parameter (the PPG measurement described in the rejection of claim 2) for measuring another parameter (blood glucose as taught by Drury) with no surprising technical effect. It would seem that the optical measurement system of modified Talmor may be optimized to monitor a wide variety of different physiological parameters using a combination of the input sensor data based on the desired use case of the system.
Regarding claim 16, Talmor discloses a system for determining a physiological parameter from a plurality of noninvasive physiological sensors arranged to interrogate tissue of a patient (Abstract), the system comprising:
the plurality of noninvasive physiological sensors disposed within nonparallel cavities fixed with respect to each other within a sensor frame (Fig. 2 reference 12: the housing having non-parallel cavities, references 18 and 20: the sensors including a camera and spectrometer arranged in the housing; Col 3 line 54- Col 4 line 9: the camera and spectrometer arranged in the housing), wherein at least some of the plurality of noninvasive sensors are configured to obtain physiological data from one of a plurality of tissue regions of the patient, wherein the plurality of tissue regions overlap in a common volumetric region of a tissue of the patient (Fig. 2: the overlap of the camera field of view with the light guide at the treatment site; Col 3 line 54 – Col 4 line 42: the light guide is within the field of view of the camera); and
a hardware processor (Col 5 lines 34-48: the computer) configured to:
receive a plurality of data signals from the plurality of noninvasive physiological sensors, wherein each of the plurality of data signals is associated with physiological data obtained by one of the plurality of noninvasive sensors (Col 5 lines 34-48: the spectrum of light received from the spectrometer; Col 5 lines 49-64: the images received from the camera).
Talmor further discloses that the spectroscopy device determines an absorption spectra of the tissue (Col 5 lines 34-48).
Talmor fails to further disclose the system including: determine the physiological parameter based at least in part on the plurality of data signals.
Tunnell teaches a multi-spectroscopy probe to be placed in contact with the user's skin comprising a plurality of fibers grouped with a source light and at least one respective modality of light (Paragraph 0027). The fiber bundle allows for multiple types of spectroscopy to be performed (Paragraph 0030) Tunnell teaches that the multi-spectroscopic probe may be used to determine a variety of parameters from the interrogated tissue including oxygen saturation (Paragraph 0036).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the spectroscopy probe of Talmor to include the fiber bundle and multiple spectroscopy techniques as taught by Tunnell because the fiber bundle and spectroscopy techniques of taught by Tunnell would allow the system of Talmor to detect a wider variety of tissue parameters and swap between various type of spectroscopic analysis based on the desired use case of the invention thus making the device useful in a wider variety of applications.
Talmor is view of Tunnell fails to further teach the system including: determine the physiological parameter based at least in part on the plurality of data signals.
Drury teaches a biosensor array device for physiological status monitoring (Abstract). Thus, Drury falls within the same field of endeavor as Applicant’s invention.
Drury teaches that CCD cameras may be configured to optically detect parameters such as heart rate (Paragraph 0102). Drury further teaches that inputs from various sensor types may be combined to determine physiological parameters (Paragraph 0135). Drury teaches one such combination as a combination of one or more optical sensors which detect heart rate and oxygen saturation in order to generate a PPG signal. Drury further teaches that optical sensors can be configured to detect a variety of different parameters (Paragraph 0113).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the CCD camera of Talmor (Talmor: Col 4 lines 43-65) to detect physiological parameters such as heart rate as taught by Drury and to further configure the system of Talmor in view of Tunnell to determine physiological parameters using a combination of inputs from the different sensors as taught by Drury because configuring the camera of Talmor to detect physiological parameters allows the system to detect a wider variety of parameters which may provide more useful insight into a patient’s condition and configuring the system to determine physiological parameters using a combination of different inputs may improve the accuracy of those determinations since multiple sources of sensor data may be less subject to interference, noise, or other affects that may affect the accuracy of the data and also may allow the device to determine a wider variety of parameters that would otherwise be possible if data from different sensors could not be considered in combination.
Regarding claim 17, Talmor in view of Tunnell further in view of Drury teaches the system of Claim 16. Modified Talmor further teaches the system wherein the sensor frame comprises: a surface configured to contact a zone of tissue of the patient at the common volumetric region (Fig. 2 references 30 and 12: the window and the portion of the housing that contacts the patient; Col 4 lines 25-42: the window extending across the opening), wherein the sensor frame is configured to support at least a portion of each of the plurality of noninvasive physiological sensors (Fig. 4 references 12, 18, and 22: the housing may support the sensors; Col 3 lines 54-65 and Col 5 lines 26-34: the sensors may be disposed in the housing), wherein the zone of tissue overlaps at least a portion of each of the plurality of tissue regions (Fig. 2 references 30 and 12: the window and the portion of the housing that contacts the patient; Col 4 lines 25-42: the window extending across the opening).
Regarding claim 18, Talmor in view of Tunnell further in view of Drury teaches the system of Claim 17. Modified Talmor further teaches the system wherein, wherein the plurality of tissue regions are within an area defined by a perimeter of the surface of a sensor head of the sensor frame (Fig. 2 references 30 and 12: the window and the portion of the housing that contacts the patient and surrounds the window; Col 4 lines 25-42: the window extending across the opening).
Regarding claim 19, Talmor in view of Tunnell further in view of Drury teaches the system of Claim 17. Modified Talmor further teaches the system wherein, wherein at least two of the plurality of noninvasive physiological sensors are configured to simultaneously obtain the physiological data (Col 5 lines 49-64: the camera and spectroscopy system provide data simultaneously)
Modified Talmor is further consider to at least suggest the limitation: while the sensor frame is stationary relative to the tissue in Col 2 lines 23-33 where Talmor states that the system allows treatment of the treatment sight without requiring the light source to be moved while spectral emissions from the treatment site are measured. Talmor does not disclose any mechanism for moving the light source relative to the housing and states that the light source does not move during spectral measurement. Thus, Talmor is considered to at least suggest that the frame and all sensors therein remain stationary relative to the tissue site during measurement.
Regarding claim 20, Talmor in view of Tunnell further in view of Drury teaches the system of Claim 16. Modified Talmor fails to further teach the system wherein, wherein at least two of the plurality of noninvasive physiological sensors are configured to obtain the physiological data at non-overlapping time intervals.
Drury teaches that biosensors may perform measurements simultaneously, sequentially, or at other times (Paragraph 0369).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the sensors of modified Talmor to obtain data sequentially as taught by Drury because sequential data collection may prevent interference between the different modalities of data collection, and/or is a simple substitution of one known element (simultaneous data acquisition) for another known element (sequential data acquisition) with no surprising technical effect.
Claims 8 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Talmor US Patent Number US 5851181 A hereinafter Talmor in view of Tunnell US Patent Application Publication Number US 2017/0224220 A1 hereinafter Tunnell in view of Drury US Patent Application Publication Number US 2017/0188864 A1 hereinafter Drury as applied to claims 2 and 16 above and further in view of Lee US Patent Application Publication Number US 2014/0303502 A1 hereinafter Lee
Regarding claims 8 and 21, Talmor in view of Tunnell further in view of Drury teaches the system of Claims 2 and 16 respectively. Modified Talmor fails to further teach the system, wherein the first noninvasive sensor comprises at least one of an optical coherence tomography (OCT) device, a Raman spectroscopy device, a bio-impedance-sensing device, a temperature-sensing device, or a pulse oximetry device, wherein the second noninvasive sensor comprises a different one of the optical coherence tomography (OCT) device, the Raman spectroscopy device, the bio-impedance-sensing device, the temperature-sensing device, or the pulse oximetry device.
Tunnell teaches a multi-spectroscopy probe to be placed in contact with the user's skin comprising a plurality of fibers grouped with a source light and at least one respective modality of light. The spectroscopy modalities may include Raman spectroscopy (Paragraphs 0027-0028). The fiber bundle allows for multiple types of spectroscopy to be performed (Paragraph 0030) Tunnell teaches that the multi-spectroscopic probe may be used to determine a variety of parameters from the interrogated tissue including oxygen saturation (Paragraph 0036).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the spectroscopy probe of modified Talmor to include the fiber bundle and multiple spectroscopy techniques including Raman spectroscopy as taught by Tunnell because the fiber bundle and spectroscopy techniques of taught by Tunnell would allow the system of Talmor to detect a wider variety of tissue parameters and swap between various type of spectroscopic analysis based on the desired use case of the invention thus making the device useful in a wider variety of applications.
Modified Talmor in view of Tunnell fails to further teach the system wherein the second noninvasive sensor comprises a different one of the optical coherence tomography (OCT) device, the Raman spectroscopy device, the bio-impedance-sensing device, the temperature-sensing device, or the pulse oximetry device.
Lee teaches a method of measuring heartbeats without contact and wirelessly. The method includes searching for a sport point on which heartbeats are measured; imaging a found spot point through a thermal graphic camera and obtaining temperature related data wirelessly; and analyzing the obtained temperature related data and calculating heartbeats (Abstract). Thus, Lee is reasonably pertinent to the problem at hand.
Lee teaches that a thermal camera may be used to collect temperature data and to determine heartbeats (Paragraphs 0007-0008 and 0012-0013). The thermal camera may capture images which are analyzed to detect heartbeats from the temperature data (Paragraphs 0026-0029).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the camera of modified Talmor to be a thermal graphic camera as taught by Lee because Lee teaches that such cameras provide temperature information and may be used to calculate heartbeats and thus configuring the camera of modified Talmor to be a thermal camera would allow the system to collect an additional parameter of temperature which may provide additional contextual information about the patient and/or sensor site and may be used to for calibrating the spectroscopy sensors. The thermal camera further retains the functionality of the CCD camera of being capable of detecting heart beats and thus heart rate and providing an image of the measurement site.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Talmor US Patent Number US 5851181 A hereinafter Talmor in view of Tunnell US Patent Application Publication Number US 2017/0224220 A1 hereinafter Tunnell in view of Drury US Patent Application Publication Number US 2017/0188864 A1 hereinafter Drury as applied to claim 2 above and further in view of Chen US Patent Application Publication Number US 2011/0098572 A1 hereinafter Chen
Regarding claim 13, Talmor in view of Tunnell further in view of Drury teaches the system of Claim 2. Modified Talmor fails to further teach the system wherein the first noninvasive sensor comprises an OCT device, wherein the OCT device comprises an optical fiber and a mirror.
Chen teaches an imaging probe for a biological sample includes an OCT probe and an ultrasound probe combined with the OCT probe in an integral probe package capable of providing by a single scanning operation images from the OCT probe and ultrasound probe to simultaneously provide integrated optical coherence tomography (OCT) and ultrasound imaging of the same biological sample. A method to provide high resolution imaging of biomedical tissue includes the steps of finding an area of interest using the guidance of ultrasound imaging, and obtaining an OCT image and once the area of interest is identified where the combination of the two imaging modalities yields high resolution OCT and deep penetration depth ultrasound imaging (Abstract). Thus, Chen falls within the same field of endeavor as Applicant's invention.
Chen teaches a noninvasive and portable probe for providing superior images and image resolution for tissue and blood vessel cross-sectional imaging (Paragraph 0026). The probe includes an optical coherence tomography (OCT) fiber for transmitting light and lens with an adjustable focal length (Paragraph 0077). The OCT probe further comprises a mirror or reflector (Paragraphs 0082 and 0084).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the OCT imaging modality taught by Chen into the system of modified Talmor because the OCT imaging of Chen provides high resolution images of the skin and structures a few millimeters below the skin (Chen: Paragraph 0012) and Talmor is directed towards monitoring the users skin (Col 5 lines 34-64). Thus incorporating the OCT imaging of Chen into modified Talmor would provide Talmor with an additional method of monitoring the user's skin and potentially identifying structures of interest below the surface of the skin.
Response to Arguments
Applicant’s arguments with respect to claim(s) 2 and 16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791