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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/27/2024 has been considered by the examiner.
Claim Objections
Claims 1, 12, 14-18, and 22 are objected to because of the following informalities:
Claims 1 and 22 should be rearranged such that the claim is easier to read. The current iteration of the claims lumps the limitations into a bulky paragraph. The limitations should be delineated in a fashion more-consistent with accepted patent practice.
Although the courts have found that the use of the term “and/or” would not be indefinite, (Employers Mut. Liability Ins. Co. v. Tollefsen, 219 Wis. 434 (1935)), the board did note that the preferred way of writing the claim is through use of “at least one of A and B" in the future. Therefore, the Examiner object to the terms "and/or" in claims 12 and 14-18 such that it is written in accordance with the courts preferred way.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4-8, 14, and 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hatschek (US 5309916 A, published May 10, 1994), hereinafter referred to as Hatschek.
Regarding claim 1, and similarly for claim 22, Hatschek teaches a physiological parameters monitoring device comprising:
at least one coherent light source (laser) configured to emit light in one or more wavelengths onto a tissue of an examined subject at a measurement point (see col. 10, lines 11-18 – “In operation, the laser light emitting diodes of the light sources generate coherent, monochromatic light…such light, which lies in the near infrared range, is able to penetrate the tissue of the arm and the walls of all arteries present in arm 1…”);
at least one light detector configured to measure intensity of light received from said tissue, and generate measurement data/signals indicative thereof (see col. 10, lines 24-27 – “The light receivers 29 are also arranged in such a way that they are able to receive light exiting from the arm at approximately a right angle to the surface of arm 1.”); and
a control unit (includes supply and detector unit 61) configured to
control the operation and process the measurement data/signals generated by said at least one light detector and simultaneously determine therefrom a pulsating blood flow signal and a pulsating blood volume signal (see col. 11, lines 32-36 – “The supply and detector unit 61 further includes circuit means for determining, on the basis of the scattered-back light, the flow velocities of the pulsating arterial blood in the measuring regions of arm 1 covered by the two sensors 21, 23.”; see col. 21, lines 57-62 – “Device 311 thus enables the determination in the two measuring regions of a first value which is a relative measure for the volume and/or the flow quantity of the blood and/or the passage cross section area and/or the inner diameter of at least one blood vessel.”), and
determine from said pulsating blood flow and volume signals a blood pressure measure of the examined subject at the measurement point as a function of time (see col. 12, lines 20-24 – “As already discussed in the introduction, the pulsating pumping of the blood causes periodic changes in blood pressure over time which are synchronous with the pulse beat and which propagate at the pulse wave velocity.”; see col. 16, lines 1-9 – “Evaluation unit 65 is configured in such a way as to link values formed from the put-in calibration values and from values for the two measured variables-that is the flow velocity and/or the flow quantity [volume] and the pulse wave velocity-in a predetermined manner so that a value is formed and represented by an electrical signal which is a measure for at least one characteristic blood pressure value, preferably including the particularly important systolic blood pressure ps”.”).
Furthermore, regarding claim 4, Hatschek further teaches wherein the blood pressure measure is determined from the time derivative of the pulsating blood volume signal and from an amplitude of the pulsating blood flow signal measured at two separate time points (see col. 21, lines 50-53 – “The electronic circuit means of unit 341 may further be configured to perform an electrical differentiating process in analog or digital form and derive there from the first derivative of the volume over time.”).
Furthermore, regarding claim 5, Hatschek further teaches wherein the two separate time points are separated by at least two sample points (Fig. 9, flow velocity v vs. time t; see col. 23, lines 33-36 – “The time difference Td between the two maxima 501a and 501c [time/sample points] therefore is a measure for the travel time of the reflected pulse waves and thus for the pulse wave velocity.”).
Furthermore, regarding claim 6, Hatschek further teaches wherein the control unit is configured to determine a pulse-wave-velocity (PWV) time function measure M(t,t+Δt), based on the determined pulsating blood flow and volume signals, and use said PWV time function measure to compute the blood pressure measure of the examined subject (see col. 22, lines 1-6 – “The evaluation unit that is part of the electronic circuit means 343 may additionally be configured to determine the blood pressure from at least one of the variants measured as the first value in at least one measuring region for the pulse wave velocity cpw and the calibration values…”).
Furthermore, regarding claim 7, Hatschek further teaches wherein the control unit is configured to receive blood pressure measurement data/signals generated by an auxiliary sensor device associated with a different tissue of the examined subject, and use said blood pressure measurement data/signals to determine a calibration biasing value β and a calibration factoring value ϵ for the computation of the blood pressure measure of the examined subject from the determined PWV time function measure (see col. 16, lines 53-61 – “The blood pressure values measured by calibration measuring unit 71 can be fed by means of calibration value input unit 63 to the evaluation unit 65, which determines the two constants k1 and p1 and then stores them in an erasable memory until the next calibration. The evaluation unit, moreover, may be configured and/or programmed to associate a value of the function f1(v, cpw) from the stored table with the values of v and cpw [pulse wave velocity (PWV)] and calculate the momentary blood pressure from these values according to Equation (9).”).
Furthermore, regarding claim 8, Hatschek further teaches wherein the control unit is configured to determine the blood pressure measure of the examined subject by computation of the expression ϵ*M(t,t+Δt)2+β (see col. 16, lines 57-61 – “The evaluation unit, moreover, may be configured and/or programmed to associate a value of the function f1(v, cpw) from the stored table with the values of v and cpw [pulse wave velocity (PWV)] and calculate the momentary blood pressure from these values according to Equation (9).”).
Furthermore, regarding claim 14, Hatschek further teaches wherein the control unit is configured to issue alerts indicative of changes in a clinical or physiological state of the examined subject based on one or more of the pulsating blood volume and/or flow signals, and/or the determined blood pressure measure, and/or a correlation thereof (see col. 19, lines 20-27 – “Evaluation unit 65 of device 11 is then able to compare, during the measurement, the continuously newly determined values of ps [systolic blood pressure] and f [pulse rate] with predetermined cutoff values and to generate an appropriate electrical signal if a cutoff value is exceeded or not reached and to feed such signal to alarm unit 51 and, if required, to the possibly additionally provided central monitoring and alarm unit.”).
Furthermore, regarding claim 21, Hatschek further teaches where the device is configured as a wearable device (see col. 9, lines 49-56 – “A device 11 shown in FIGS. 1 and 2 serves to measure blood pressure and pulse rate and is provided with sensor means 13 that are disposed on the exterior of arm 1-namely at the forearm. These sensor means include a holder 15 that is releasably fastened to arm 1 and is composed of an elongate, plate or strip-shaped holding member 17, made, for example, of a not very flexible, electrically insulating plastic.”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hatschek in view of Carek et al. (US 20230225623 A1, published July 20, 2023 with a priority date of March 20, 2020), hereinafter referred to as Carek.
Regarding claim 3, Hatschek teaches all of the elements disclosed in claim 1 above.
Hatschek teaches acquiring measurement data, but does not explicitly teach acquiring measurement data at a sample rate greater than 100Hz.
Whereas, Carek, in an analogous field of endeavor, teaches wherein the control unit is configured to acquire the measurement data/signals at a sample rate greater than 100Hz (see para. 0185 – “When an object approaches the sensor, as when the user places the watch on the wrist (FIG. 6B) an interrupt flag is set, and the watch transitions to continuous mode. During this mode, the green PPGs, accelerometer, and gyroscope are active and sample at 125 Hz.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified acquiring measurement data, as disclosed in Hatschek, by acquiring measurement data at a sample rate greater than 100Hz, as disclosed in Carek. One of ordinary skill in the art would have been motivated to make this modification in order to save power while providing enough context for activity classification of the user, as taught in Carek (see para. 0143).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hatschek in view of Shim et al. (US 20210255092 A1, published August 19, 2021), hereinafter referred to as Shim.
Regarding claim 9, Hatschek teaches all of the elements disclosed in claim 1 above.
Hatschek teaches an ultrasound transducer configured to induce acoustic signals in the examined tissue (see col. 20, lines 2-5 – “…the ultrasound transducers project pulsed ultrasonic waves into the arm and, between successive pulses, receive ultrasonic waves that are reflected or scattered back.”), but does not explicitly teach the ultrasound transducer is configured to induce acoustic signals in the examined tissue for modulating the light received by the at least one light detector.
Whereas, Shim, in an analogous field of endeavor, teaches an ultrasound transducer configured to induce acoustic signals in the examined tissue for modulating the light received by the at least one light detector (see para. 0062 – “Also, the signal detection sensor 310 may further include an ultrasonic generator that transmits an ultrasonic wave to a measurement area in order to modulate the light signal emitted by the light source.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified an ultrasound transducer configured to induce acoustic signals in the examined tissue, as disclosed in Hatschek, by having the ultrasound transducer configured to induce acoustic signals in the examined tissue for modulating the light received by the at least one light detector, as disclosed in Shim. One of ordinary skill in the art would have been motivated to make this modification in order to more accurately detect a light signal of the desired measurement area, as taught in Shim (see para. 0080).
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hatschek in view of Addison (US 20200146636 A1, published May 14, 2020), hereinafter referred to as Addison.
Regarding claim 10, Hatschek teaches all of the elements disclosed in claim 1 above.
Hatschek teaches determining pulsating blood flow or volume signal and blood pressure, but does not explicitly teach determining a measure of autoregulation based on a correlation between the determined pulsating blood flow or volume signal and the determined blood pressure measure.
Whereas, Addison, in an analogous field of endeavor, teaches wherein the control unit is configured to determine correlation between the determined pulsating blood flow or volume signal and the determined blood pressure measure, and determine based thereon a measure of vascular reactivity or autoregulation of the examined subject (see para. 0023 – “The processing circuitry can determine a hemoglobin volume index (HVx) based at least in part on a linear correlation between the patient's blood pressure and blood volume. The processing circuitry can then determine an estimate of the limit of cerebral autoregulation based on the HVx values (LAHVx).”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified determining pulsating blood flow or volume signal and blood pressure, as disclosed in Hatschek, by also determining a measure of autoregulation based on a correlation between the determined pulsating blood flow or volume signal and the determined blood pressure measure, as disclosed in Addison. One of ordinary skill in the art would have been motivated to make this modification in order to monitor the autoregulation status of a patient, e.g., during a medical procedure, and take one or more actions to keep the patient in or bring the patient to an intact autoregulation status, such as by increasing or decreasing the patient's blood pressure, as taught in Addison (see para. 0015).
Furthermore, regarding claim 11, Addison further teaches wherein the control unit is configured to issue alerts indicative of changes in perfusion state of a body part of the examined subject based on the determine correlation (see para. 0033 – “In some examples, if processing circuitry 110 determines that the autoregulation status of patient 101 is impaired, then processing circuitry 110 may present a notification indicating the impaired cerebral autoregulation status. The notification may include a visual, audible, tactile, or somatosensory notification (e.g., an alarm signal) indicative of an autoregulation status of patient 101.”).
Furthermore, regarding claim 12, Addison further teaches wherein the control unit is configured to issue the alerts for indicating of at least one of the following states: onset of severe sepsis, shock, trauma, and/or inadequate perfusion (see para. 0015 – “An intact autoregulation status of a patient occurs over a range of blood pressures defined between a lower limit of autoregulation (“LLA”) and an upper limit of autoregulation (“ULA”). An impaired autoregulation status occurs outside of the range of blood pressures defined between the LLA and the ULA and may occur when a patient's autoregulation process is not functioning properly. When a patient exhibits an impaired autoregulation status, the patient may experience inappropriate cerebral blood flow, which may be undesirable.”).
The motivation for claim 11-12 was shown previously in claim 10.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hatschek in view of Addison et al. (US 20190269334 A1, published September 5, 2019), hereinafter referred to as Addison ‘334.
Regarding claim 13, Hatschek teaches all of the elements disclosed in claim 1 above.
Hatschek teaches determining pulsating blood flow or volume signal and blood pressure, but does not explicitly teach determining a vascular reactivity measure based on the determined blood pressure measure and the determined blood pulsating blood flow signal.
Whereas, Addison ‘334, in an analogous field of endeavor, teaches wherein the control unit is configured to determine a vascular reactivity measure based on the determined blood pressure measure and the determined blood pulsating blood flow signal (see para. 0089 – “Controller 214 may be configured to determine COx values based on the blood pressure signal and the oxygen saturation signal. The COx index may be indicative of vascular reactivity, which is related to cerebral blood vessels' ability to control proper blood flow, via vasoconstriction (a narrowing of the blood vessel) and/or vasodilation (expansion of the blood vessel), for example.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified determining pulsating blood flow or volume signal and blood pressure, as disclosed in Hatschek, by also determining a vascular reactivity measure based on the determined blood pressure measure and the determined blood pulsating blood flow signal, as disclosed in Addison ‘334. One of ordinary skill in the art would have been motivated to make this modification in order to indicate whether the patient’s autoregulation is impaired, as taught in Addison ‘334 (see para. 0089).
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Hatschek in view of Valys et al. (US 20190104951 A1, published April 11, 2019), hereinafter referred to as Valys.
Regarding claim 15, Hatschek teaches all of the elements disclosed in claim 14 above.
Hatschek teaches issuing an alert indicative of changes in a clinical or physiological state of the examined subject based on blood flow signals, but does not explicitly teach issuing an alert based on a comparison of blood flow signals to corresponding signals retrieved from a database.
Whereas, Valys, in an analogous field of endeavor, teaches wherein the control unit is configured to issue the alerts based on comparison of the determined pulsating or non-pulsating blood flow and/or volume signals and/or the determined blood pressure measure, or their correlation, or a combination thereof, to corresponding measurement data/signals retrieved from a database of such measurements (see para. 0086 – “For example, if the physiological indicator used is blood pressure and the user has higher blood pressure, then embodiments may frequently alert/notify the user that his health-indicator is outside normal or healthy range from a model trained on a healthy population.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified issuing an alert indicative of changes in a clinical or physiological state of the examined subject based on blood flow signals, as disclosed in Hatschek, by issuing the alert based on a comparison of blood flow signals to corresponding signals retrieved from a database, as disclosed in Valys. One of ordinary skill in the art would have been motivated to make this modification in order to more closely match the user's personal health knowledge, as taught in Valys (see para. 0086).
Furthermore, regarding claim 16, Valys further teaches wherein the control unit is configured to issue the alerts based on machine-learning and/or deep-learning process utilizing the measurement data/signals recorded in the database of measurements (see para. 0024 – “In some embodiments, measured health-indicator data alone or in combination with other-factor data is input into a trained machine learning model that determines a probability the user's measured health-indicator is considered within a healthy range, and if not to notify the user of such.”; see para. 0086 – “For example, if the physiological indicator used is blood pressure and the user has higher blood pressure, then embodiments may frequently alert/notify the user that his health-indicator is outside normal or healthy range from a model trained on a healthy population.”).
The motivation for claim 16 was shown previously in claim 15.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hatschek in view of Lawson et al. (US 20210268267 A1, published September 2, 2021 with a priority date of February 6, 2018), hereinafter referred to as Lawson.
Regarding claim 17, Hatschek teaches all of the elements disclosed in claim 1 above.
Hatschek teaches a device determining blood flow, but does not explicitly teach the device comprising a blood flow controlling element configured to locally affect perfusion.
Whereas, Lawson, in an analogous field of endeavor, teaches a device comprising a blood flow controlling element configured to locally affect perfusion in the examined tissue responsive to instructions from the control unit, and wherein the control unit is configured to operate said blood flow controlling element based on the determined pulsating blood flow and/or volume signals and/or the determined blood pressure measure (Fig. 6; see para. 0069 – “To that end, the controller of control unit 12 optionally includes processing logic to determine a treatment regimen for increasing, optionally optimizing, such as by maximizing, the wearer's blood flow. For example, control unit 12 may stop or adjust one or more characteristics of the electrical stimulation, such as the wave form, including amplitude, duration, and pulse width based on input (sensor signals or user input). In this manner, control unit 12 can provide a closed loop feedback control of the treatment and/or monitoring of device 10.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a device determining blood flow, as disclosed in Hatschek, by having the device comprising a blood flow controlling element configured to locally affect perfusion, as disclosed in Lawson. One of ordinary skill in the art would have been motivated to make this modification in order to promote the monitoring and healing of damaged tissue, as taught in Lawson (see para. 0042).
Furthermore, regarding claim 18, Lawson further teaches wherein the blood flow controlling element is configured to controllably apply pressure to the examined tissue, and/or cool or heat the examined tissue (Fig. 6, “Apply electrical stim. [stimulation] + heat”).
The motivation for claim 18 was shown previously in claim 17.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Hatschek in view of Takanashi (US 5575285 A, published November 19, 1996), hereinafter referred to as Takanashi.
Regarding claim 20, Hatschek teaches all of the elements disclosed in claim 1 above.
Hatschek teaches a coherent light source emitting a wavelength to tissue, but does not explicitly teach the coherent light source is configured to selectively emit the light in two or more different wavelengths to determine oxygen saturation.
Whereas, Takanashi, in an analogous field of endeavor, teaches wherein the coherent light source is configured to selectively emit the light in two or more different wavelengths, and wherein the control unit is configured to determine oxygen saturation of the examined subject based on the blood pulse wave determined for said two or more different wavelengths (see Abstract – “An apparatus for non-invasively measuring the oxygen saturation in the blood of a subject comprises light sources for irradiating a sample of blood in tissue with at least a first light beam and a second light beam having different wavelengths.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a coherent light source emitting a wavelength to tissue, as disclosed in Hatschek, by having the coherent light source configured to selectively emit the light in two or more different wavelengths to determine oxygen saturation, as disclosed in Takanashi. One of ordinary skill in the art would have been motivated to make this modification in order to ensure the precise measurement of the oxygen saturation, as taught in Takanashi (see col. 3, lines 14-16).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Saeki et al. (US 20220338767 A1, published October 27, 2022 with a priority date of June 24, 2020) discloses a pressurization controller is configured to control a pressurizing operation performed with a pressurization device attached to a body of the subject, thereby changing an amount of blood flowing into/out of the living tissue.
Waller et al. (US 20170238819 A1, published August 24, 2017) discloses each sensor generates a signal based on an intensity of received light from a location against or adjacent to the sensor where a pulse wave resulting from a user's heart beat passes, and calculates one or more physiological characteristics of the user, such as blood pressure or stress, based on the generated signal from each sensor and a lateral distance therebetween.
Pantelopoulos et al. (US 20170209053 A1, published July 27, 2017) discloses estimating blood pressure, which implement a pulse-transit-time-based blood pressure model that can be calibrated.
Lading et al. (US 20170231578 A1, published August 17, 2017) discloses the control system may be capable of determining a blood flow difference based on the at least two measurements, of determining a hydrostatic pressure difference based on the two or more different elevations of the at least two measurements and of estimating a blood pressure based on one or more values of blood flow, the hydrostatic pressure difference and the blood flow difference.
Pfeiffer et al. (US 20170112396 A1, published April 27, 2017) discloses determining blood pressure in a blood vessel, according to which a pulse wave propagation time is calculated in a measuring operation by means of at least two sensors arranged at a defined distance from one another, and the blood pressure is calculated using a calibration carried out by means of a compression pressure measurement.
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/Nyrobi Celestine/Examiner, Art Unit 3798