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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/04/2026 has been entered.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6, 9-12, 15, and 18 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Hunt et al. (WO 2020/053290).
Regarding Claim 1, Hunt discloses an apparatus for performing a diagnostic measurement of blood circulation in a patient (skin perfusion pressure device – element 804; Page 35, lines 12-14), wherein the apparatus comprises:
a probe (skin perfusion pressure device – element 804) with a distal tip (805; Page 35, lines 12-14; [Examiner note: the claims do not define a direction/orientation of the distal and proximal ends of the device and therefore what may be considered “distal” to a skilled artisan will depend on the point of reference relative to the apparatus.]);
said probe having a blood circulation sensor (optical sensor – element 877) for measuring an amplitude of a pulsatile signal of blood circulating (Page 31; [Examiner’s note, the pulsatile signal is a time-domain signal.])in tissue near said distal tip of said probe when said probe is pressed against the skin of the patient (Figures 8A-B; Page 31, lines 22-34; Page 35, lines 12-14, the sensor module can be associated with and in optical communication with the proximal end 805 of the skin perfusion pressure determination device 804 to obtain a skin perfusion pressure measurement; Page 36 lines 20-22, an optical sensor can be provided in the proximal end assembly and can be in communication with the proximal end cap 808 which is configured to be in contact with the target tissue area or skin surface);
said probe having a force or pressure sensor (force sensor – element 876) for measuring a force or pressure applied by said probe to tissue in which the blood is circulating (Page 45, lines 16-19, the force and/or pressure applied to the target area by the skin perfusion pressure determination device can be measured using a first sensor within the device. The blood perfusion in the target area beneath the proximal end can be measured using a second sensor within the device.);
wherein said probe is configured to apply varying a force or pressure to tissue (Figures 8M-8T; Page 9, lines 18-25; [Examiner’s note, the spring (plunger – element 810) within the probe allows for the varying force or pressure onto the tissue.]) in which blood is circulating (Page 45, lines 16-19, the force and/or pressure applied to the target area by the skin perfusion pressure determination device can be measured using a first sensor within the device. The blood perfusion in the target area beneath the proximal end can be measured using a second sensor within the device.), and said blood circulation sensor (optical sensor – element 877) is configured to measure an amplitude of a pulsatile signal of blood circulating (Page 31) in tissue near said distal tip of said probe as a force or pressure applied to the tissue is varied (Page 31, lines 22-34); further wherein the measured amplitudes of the pulsatile signals are used to calculate a tissue perfusion pressure (TPP) of the patient (Page 32, lines 1-2).
Regarding Claim 2, Hunt discloses an apparatus according to claim 1, wherein the force or pressure is varied gradually (Hunt | Page 9, lines 5-11, the skin perfusion pressure determination device comprising a bellows portion with a spring, applying a force to the skin perfusion pressure determination device against the target area, causing the bellows portion and spring to contract until blood flow has been occluded in the target area, releasing the force applied to the target area at a controlled rate by expanding the spring, detecting when blood flow resumes in the target area, and measuring or determining the force or pressure applied to the target area by the skin perfusion pressure determination device when the blood flow resumes; [Examiner note, by applying force or pressure to the target area, skin tissue, the skin perfusion pressure determination device will measure the perfusion pressure]; Page 68, lines 12-18, the magnetic brake device 1610 can include a spring 1617 that can include a proximal end 1605 for contacting the target tissue area… the magnetic clutch 1641 can slowly release the force applied to the skin by gradually allowing two parts of the mechanism to slip relative to each other; [Examiner note, the components mentioned above are additional elements that can be added to the internal function of the probe/device. The magnetic clutch allows for gradual force or pressure applied to the patient.]).
Regarding Claim 3, Hunt discloses teaches an apparatus according to claim 1, wherein said blood circulation sensor (Hunt | optical sensor – element 877) is configured to measure at least one from the group consisting of blood volume [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.] and blood flow (Hunt | Page 36, lines 31-34, to obtain the skin perfusion pressure measurement, the proximal end cap 808 can provide a surface area that will allow for the target area to be blanched or occluded as well as allow for a sensor (i.e. located as a component in the center) to monitor the blood flow synchronously with the application of the pressure over the surface area).
Regarding Claim 6, Hunt discloses an apparatus according to claim 1, wherein said probe (Hunt | skin perfusion pressure determination device – element 804) comprises a first part and a second part, wherein said first part is movable relative to said second part (Hunt | Page 35, lines 25-27, the proximal end assembly 807 further comprises bellows 809, a plunger 810, a spring 811, and a slider 812 that can move within the device 804 to allow contraction and extension of the proximal end assembly 807), and further wherein said blood circulation sensor is carried by said first part (Hunt | Page 35, lines 12-14, the sensor module can be associated with and in optical communication with the proximal end 805 of the skin perfusion pressure determination device 804 to obtain a skin perfusion pressure measurement; Page 36 lines 20-22, an optical sensor can be provided in the proximal end assembly and can be in communication with the proximal end cap 808 which is configured to be in contact with the target tissue area or skin surface; Page 35 lines 2-3, the proximal end assembly 807 has a proximal end that defines the proximal end 805 of the device 804; [Examiner note, the citations above state the blood circulation sensor (optical sensor) is located on the distal tip (proximal end) which is carried by the first part (the proximal end assembly)].) and the force or pressure sensor (Hunt | Page 39 lines 6-9, the proximal end cap can be used to apply a force on the skin and to carry out the optical measurements. Figures 8M-8P illustrate embodiments of a portions of a proximal end assembly with force sensor 876 and optical sensor 877 incorporated into the device.) is configured to measure movement of said first and second parts relative to one another (Hunt | Page 35 lines 30-34 to Page 36 lines 1-8, when the proximal end of the skin perfusion pressure determination device 804 is applied to a surface or target tissue area (e.g. the skin of a patient or surface of a wound), a force is applied to the grip portion of the skin perfusion pressure determination device 804 by the hand of the user or other source. By applying a force to the grip portion, the user moves the grip portion towards the skin. This compresses the spring which exerts a force onto the plunger and therefore onto the skin. As part of the relative movement of the grip portion and the proximal end assembly, the bellows changes shape. Once blood flow has been occluded, the force can be released at a controlled rate allowing the proximal end assembly to expand at a controlled rate until the force has been completely removed and the proximal end assembly has returned to a resting (i.e. expanded) state. [Examiner note, this process discusses a force is applied onto the grip portion by the user. The user then moves the grip portion onto the skin of the patient and causing the spring inside the probe to compress. This compression exerts a force onto the skin. This movement allows for the proximal end, the tip that has contact with the skin, to collect the blood circulation measurement]).
Regarding Claim 9, Hunt discloses an apparatus according to claim 1, wherein said probe (Hunt | skin perfusion pressure determination device – element 804; Page 7 lines 3-4 and 16-25) is mounted to a fixture (Hunt | spring – element 1917; Page 73 lines 19-22; Page 11 lines 23-24) so that said distal tip contacts a patient (Hunt | Page 38 lines 32-34 to Page 39 lines 1-12; [Examiner’s note, the proximal end cap (808) is part of the skin perfusion determination device (804)].), and wherein said probe further comprises an actuator (Hunt | motor – element 1960; Page 73 lines 24-27) for applying a force or pressure to the patient (Hunt | Page 73 lines 28-34 to Page 74 lines 1-2; [Examiner note, the means for applying a force or pressure to the patient is done by the spring, element 811, found in the skin perfusion pressure determination device (the probe) in element 804]).
Regarding Claim 10, Hunt discloses a method for performing a diagnostic measurement of blood circulation in a patient (skin perfusion pressure device – element 804; Page 35, lines 12-14), wherein the method comprises:
providing an apparatus (skin perfusion pressure device – element 804; Page 35, lines 12-14) comprising:
a probe (skin perfusion pressure device – element 804) with a distal tip (805; Page 35, lines 12-14; [Examiner note: the claims do not define a direction/orientation of the distal and proximal ends of the device and therefore what may be considered “distal” to a skilled artisan will depend on the point of reference relative to the apparatus.]);
said probe having a blood circulation sensor (optical sensor – element 877) for measuring an amplitude of a pulsatile signal of blood circulating (Page 31; [Examiner’s note, the pulsatile signal is a time-domain signal.]) in tissue near said distal tip of said probe when said probe is pressed against the skin of the patient (Figures 8A-B; Page 31, lines 22-34; Page 35, lines 12-14, the sensor module can be associated with and in optical communication with the proximal end 805 of the skin perfusion pressure determination device 804 to obtain a skin perfusion pressure measurement; Page 36 lines 20-22, an optical sensor can be provided in the proximal end assembly and can be in communication with the proximal end cap 808 which is configured to be in contact with the target tissue area or skin surface”; [Examiner note, one skilled in the art can understand a pulse amplitude and amplitude of a pulsatile signal are the same.]); and
said probe having a force or pressure sensor (force sensor – element 876) for measuring a force or pressure applied by said probe to tissue in which the blood is circulating (Page 45, lines 16-19, the force and/or pressure applied to the target area by the skin perfusion pressure determination device can be measured using a first sensor within the device. The blood perfusion in the target area beneath the proximal end can be measured using a second sensor within the device.);
pressing said distal tip of said probe against a patient (Page 36 lines 20-22);
using said blood circulation sensor (optical sensor – element 877) to measure an amplitude of a pulsatile signal of blood circulating (Page 31; [Examiner’s note, the pulsatile signal is a time-domain signal.]) in tissue near said distal tip of said probe (Page 31, lines 22-34);
using said force or pressure sensor (force sensor – element 876) to measure a force or pressure applied by said probe to the tissue in which the blood is circulating (Page 45, lines 16-19, the force and/or pressure applied to the target area by the skin perfusion pressure determination device can be measured using a first sensor within the device. The blood perfusion in the target area beneath the proximal end can be measured using a second sensor within the device.);
varying the force or pressure applied to tissue (Figures 8M-8T; Page 9, lines 18-25; [Examiner’s note, the spring (plunger – element 810) within the probe allows for the varying force or pressure onto the tissue.]) in which the blood is circulating (Page 45, lines 16-19, the force and/or pressure applied to the target area by the skin perfusion pressure determination device can be measured using a first sensor within the device. The blood perfusion in the target area beneath the proximal end can be measured using a second sensor within the device.);
using said blood circulation sensor (optical sensor – element 877) to measure the amplitude of the pulsatile signal of blood circulating (Page 31; [Examiner’s note, the pulsatile signal is a time-domain signal.]) in tissue near said distal tip of said probe as the force or pressure applied to tissue in which the blood is circulating is varied (Page 31, lines 22-34);
using the measured amplitudes of the pulsatile signals are used to calculate a tissue perfusion pressure (TPP) of the patient (Page 32, lines 1-2).
Regarding Claim 11, Hunt discloses a method according to claim 10, wherein the force or pressure is varied gradually (Hunt | Page 9, lines 5-11, the skin perfusion pressure determination device comprising a bellows portion with a spring, applying a force to the skin perfusion pressure determination device against the target area, causing the bellows portion and spring to contract until blood flow has been occluded in the target area, releasing the force applied to the target area at a controlled rate by expanding the spring, detecting when blood flow resumes in the target area, and measuring or determining the force or pressure applied to the target area by the skin perfusion pressure determination device when the blood flow resumes. [Examiner note, by applying force or pressure to the target area, skin tissue, the skin perfusion pressure determination device will measure the perfusion pressure]; Page 68, lines 12-18, the magnetic brake device 1610 can include a spring 1617 that can include a proximal end 1605 for contacting the target tissue area… the magnetic clutch 1641 can slowly release the force applied to the skin by gradually allowing two parts of the mechanism to slip relative to each other; [Examiner note, the components mentioned above are additional elements that can be added to the internal function of the probe/device. The magnetic clutch allows for the gradual force or pressure applied to the patient.]).
Regarding Claim 12, Hunt discloses a method according to claim 10, wherein said blood circulation sensor (Hunt | optical sensor – element 877) measures at least one from the group consisting of blood volume [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.] and blood flow (Hunt | Page 36, lines 31-34, to obtain the skin perfusion pressure measurement, the proximal end cap 808 can provide a surface area that will allow for the target area to be blanched or occluded as well as allow for a sensor (i.e. located as a component in the center) to monitor the blood flow synchronously with the application of the pressure over the surface area).
Regarding Claim 15, Hunt discloses a method according to claim 10, wherein said probe (Hunt | skin perfusion pressure determination device – element 804) comprises a first part and a second part, wherein said first part is movable relative to said second part (Hunt | Page 35, lines 25-27, the proximal end assembly 807 further comprises bellows 809, a plunger 810, a spring 811, and a slider 812 that can move within the device 804 to allow contraction and extension of the proximal end assembly 807), and further wherein said blood circulation sensor is carried by said first part (Hunt | Page 35, lines 12-14, the sensor module can be associated with and in optical communication with the proximal end 805 of the skin perfusion pressure determination device 804 to obtain a skin perfusion pressure measurement; Page 36 lines 20-22, an optical sensor can be provided in the proximal end assembly and can be in communication with the proximal end cap 808 which is configured to be in contact with the target tissue area or skin surface; Page 35 lines 2-3, the proximal end assembly 807 has a proximal end that defines the proximal end 805 of the device 804; [Examiner note, the citations above state the blood circulation sensor (optical sensor) is located on the distal tip (proximal end) which is carried by the first part (the proximal end assembly)].) and the force or pressure sensor (Hunt | Page 39 lines 6-9, the proximal end cap can be used to apply a force on the skin and to carry out the optical measurements. Figures 8M-8P illustrate embodiments of a portions of a proximal end assembly with force sensor 876 and optical sensor 877 incorporated into the device.) is configured to measure movement of said first and second parts relative to one another (Hunt | Page 35 lines 30-34 to Page 36 lines 1-8, when the proximal end of the skin perfusion pressure determination device 804 is applied to a surface or target tissue area (e.g. the skin of a patient or surface of a wound), a force is applied to the grip portion of the skin perfusion pressure determination device 804 by the hand of the user or other source. By applying a force to the grip portion, the user moves the grip portion towards the skin. This compresses the spring which exerts a force onto the plunger and therefore onto the skin. As part of the relative movement of the grip portion and the proximal end assembly, the bellows changes shape. Once blood flow has been occluded, the force can be released at a controlled rate allowing the proximal end assembly to expand at a controlled rate until the force has been completely removed and the proximal end assembly has returned to a resting (i.e. expanded) state. [Examiner note, this process discusses a force is applied onto the grip portion by the user. The user then moves the grip portion onto the skin of the patient and causing the spring inside the probe to compress. This compression exerts a force onto the skin. This movement allows for the proximal end, the tip that has contact with the skin, to collect the blood circulation measurement]).
Regarding Claim 18, Hunt discloses a method according to claim 10, wherein said probe (Hunt | skin perfusion pressure determination device – element 804; Page 7 lines 3-4 and 16-25) is mounted to a fixture (Hunt | spring – element 1917; Page 73 lines 19-22; Page 11 lines 23-24) so that said distal tip contacts a patient (Hunt | Page 38 lines 32-34 to Page 39 lines 1-12; [Examiner’s note, the proximal end cap (808) is part of the skin perfusion determination device (804)].), and wherein said probe further comprises an actuator (Hunt | motor – element 1960; Page 73 lines 24-27) for applying a force or pressure to the patient (Hunt | Page 73 lines 28-34 to Page 74 lines 1-2; [Examiner note, the means for applying a force or pressure to the patient is done by the spring, element 811, found in the skin perfusion pressure determination device (the probe) in element 804]).
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.
Claims 4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hunt et al. (WO 2020/053290).
Regarding Claim 4, Hunt discloses an apparatus according to claim 1. However, Hunt is silent in teaching the blood circulation sensor is a PPG sensor. Another embodiment of Hunt teaches blood circulation sensor comprises a photoplethysmography sensor (Hunt | Page 30, lines 14-17, the upper trace is a photoplethysmogram (PPG) which provides an indication of the amount of light emitted by the LED 22 that is absorbed by the skin tissue at the target area (i.e. the trace is inversely proportional to the amount of light reflected by the skin tissue at the target area and received by the photodiode 24)). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the skin perfusion pressure device from Hunt in view of Thaveeprungsriporn to incorporate the teachings of a PPG Sensor from another embodiment of Hunt because the PPG sensor measures the blood flow within the target tissue and determines the pulse amplitude (Hunt | Page 30 lines 14-33).
Regarding Claim 13, Hunt discloses a method according to claim 10. However, Hunt is silent in teaching the blood circulation sensor is a PPG sensor. Another embodiment of Hunt teaches blood circulation sensor comprises a photoplethysmography sensor (Hunt | Page 30, lines 14-17, the upper trace is a photoplethysmogram (PPG) which provides an indication of the amount of light emitted by the LED 22 that is absorbed by the skin tissue at the target area (i.e. the trace is inversely proportional to the amount of light reflected by the skin tissue at the target area and received by the photodiode 24)). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the skin perfusion pressure device from Hunt to incorporate the teachings of a PPG Sensor from another embodiment of Hunt because the PPG sensor measures the blood flow within the target tissue and determines the pulse amplitude (Hunt | Page 30 lines 14-33).
Claims 5, 7, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Hunt in view of Pantelopoulos et al. (US 20170209055 A1).
Regarding Claim 5, Hunt discloses an apparatus according to claim 4. Hunt is silent in teaching the blood circulation sensor is a PPG sensor. Another embodiment of Hunt teaches blood circulation sensor comprises a photoplethysmography sensor (Hunt | Page 30, lines 14-17, the upper trace is a photoplethysmogram (PPG) which provides an indication of the amount of light emitted by the LED 22 that is absorbed by the skin tissue at the target area (i.e. the trace is inversely proportional to the amount of light reflected by the skin tissue at the target area and received by the photodiode 24)). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the skin perfusion pressure device from Hunt to incorporate the teachings of a PPG Sensor from another embodiment of Hunt because the PPG sensor measures the blood flow within the target tissue and determines the pulse amplitude (Hunt | Page 30 lines 14-33).
Hunt is silent in teaching said photoplethysmography sensor has a sample rate greater than 5 Hz. Pantelopoulos teaches an apparatus (Pantelopoulos | biometric monitoring device; Figure 14 [Examiner note, Figure 14 illustrates a user wearing the biometric monitoring device.]) that includes a photoplethysmography (Pantelopoulos | Paragraph 0174, a biometric monitoring device employs optical techniques to acquire pulse waveform measurement or heart rate measurements or data, e.g., by using photoplethysmography) sensor has a sample rate greater than 5 Hz (Paragraph 0116, the sampling rate is at least about 25 Hz, 50 Hz, 100 Hz, 150 Hz, 200 Hz, or 400 Hz. In some implementations, the PPG sensor operates at a lower sampling frequency (e.g., less than about 25 Hz) before entering pulse waveform data collection, and increases sampling rate when triggered to collect pulse waveform data). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the PPG sensor of Hunt to incorporate the teachings of the sampling rate from Pantelopoulos because the sample rate is used to measure the pulse amplitude from the target tissue (Pantelopoulos | Paragraph 0116, Because PWA requires extracting morphological features from pulse waveforms, it is desirable to have high sampling rate and sufficient signal strength. In various implementations, the sampling rate is at least about 25 Hz, 50 Hz, 100 Hz, 150 Hz, 200 Hz, or 400 Hz.).
Regarding Claim 7, Hunt discloses an apparatus according to claim 6, wherein said force or pressure sensor comprises an element selected from the group consisting of a strain gauge (Hunt | Page 33 lines 12-15, alternative sensors for determining a parameter associated with a pressure exerted on the target area may be used. In particular, sensors which have a thickness which corresponds to, or is less than, the thickness of a typical wound dressing may be used. Suitable capacitive, resistive thin-film or micromachined sensors or strain gauges or the like may be used; [Examiner note, a pressure gauge is used as an element for the force or pressure sensor]), and a pressure sensor (Hunt | force sensor – element 876; Page 33 lines 18-21, alternative types of sensor[s] which produce an output which can be used to determine a parameter associated with the pressure exerted on or stress created at the target area by a sensor module may be used. Such sensors may include sensors configured to output a pressure applied by the sensor or the sensor module to the target area [Examiner note, an alternative sensor mention in this section discusses a pressure sensor]).
Hunt is silent in teaching the force or pressure sensor comprises an element selected from the group consisting of a potentiometer. Pantelopoulos teaches the force or pressure sensor comprises a potentiometer (Pantelopoulos | Paragraph 0019, the pressure sensor may be one or more of the following: a force sensor, force sensitive resistor, mechanical sensor, load sensor, load cell, strain gauge, piezo sensor, membrane potentiometer, or any other suitable pressure sensor; [Examiner note, a membrane potentiometer is a specialized type of potentiometer that is more flexible and thinner than a standard potentiometer; the function between the two are the same]). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the force or pressure sensor of Hunt to incorporate the teachings of the potentiometer from Pantelopoulos because the membrane potentiometer is used to normalize the pulse amplitude collected from the PPG sensor (Pantelopoulos | Paragraph 0162).
Regarding Claim 14, Hunt teaches a method according to claim 13. However, Hunt is silent in teaching the blood circulation sensor is a PPG sensor. Another embodiment of Hunt teaches blood circulation sensor comprises a photoplethysmography sensor (Hunt | Page 30, lines 14-17, the upper trace is a photoplethysmogram (PPG) which provides an indication of the amount of light emitted by the LED 22 that is absorbed by the skin tissue at the target area (i.e. the trace is inversely proportional to the amount of light reflected by the skin tissue at the target area and received by the photodiode 24)). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the skin perfusion pressure device from Hunt to incorporate the teachings of a PPG Sensor from another embodiment of Hunt because the PPG sensor measures the blood flow within the target tissue and determines the pulse amplitude (Hunt | Page 30 lines 14-33).
Additionally, Hunt is silent in teaching said photoplethysmography sensor has a sample rate greater than 5 Hz. Pantelopoulos teaches an apparatus (biometric monitoring device; Figure 14 [Examiner note, Figure 14 illustrates a user wearing the biometric monitoring device.]) that includes a photoplethysmography (Paragraph 0174, a biometric monitoring device employs optical techniques to acquire pulse waveform measurement or heart rate measurements or data, e.g., by using photoplethysmography) sensor has a sample rate greater than 5 Hz (Paragraph 0116, the sampling rate is at least about 25 Hz, 50 Hz, 100 Hz, 150 Hz, 200 Hz, or 400 Hz. In some implementations, the PPG sensor operates at a lower sampling frequency (e.g., less than about 25 Hz) before entering pulse waveform data collection, and increases sampling rate when triggered to collect pulse waveform data). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the PPG sensor of Hunt to have the sampling rate teachings of Pantelopoulos because the sample rate is used to measure the pulse amplitude from the target tissue (Pantelopoulos | Paragraph 0116, Because PWA requires extracting morphological features from pulse waveforms, it is desirable to have high sampling rate and sufficient signal strength. In various implementations, the sampling rate is at least about 25 Hz, 50 Hz, 100 Hz, 150 Hz, 200 Hz, or 400 Hz.).
Regarding Claim 16, Hunt discloses a method according to claim 15, wherein said force or pressure sensor comprises an element selected from the group consisting of a strain gauge (Hunt | Page 33 lines 12-15, alternative sensors for determining a parameter associated with a pressure exerted on the target area may be used. In particular, sensors which have a thickness which corresponds to, or is less than, the thickness of a typical wound dressing may be used. Suitable capacitive, resistive thin-film or micromachined sensors or strain gauges or the like may be used; [Examiner note, a pressure gauge is used as an element for the force or pressure sensor]), and a pressure sensor (Hunt | force sensor – element 876; Page 33 lines 18-21, alternative types of sensor[s] which produce an output which can be used to determine a parameter associated with the pressure exerted on or stress created at the target area by a sensor module may be used. Such sensors may include sensors configured to output a pressure applied by the sensor or the sensor module to the target area [Examiner note, an alternative sensor mention in this section discusses a pressure sensor]).
Hunt is silent in teaching the force or pressure sensor comprises an element selected from the group consisting of a potentiometer. Pantelopoulos teaches the force or pressure sensor comprises a potentiometer (Pantelopoulos | Paragraph 0019, the pressure sensor may be one or more of the following: a force sensor, force sensitive resistor, mechanical sensor, load sensor, load cell, strain gauge, piezo sensor, membrane potentiometer, or any other suitable pressure sensor; [Examiner note, a membrane potentiometer is a specialized type of potentiometer that is more flexible and thinner than a standard potentiometer; the function between the two are the same]). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the force or pressure sensor of Hunt to incorporate the teachings of the potentiometer from Pantelopoulos because the membrane potentiometer is used to normalize the pulse amplitude collected from the PPG sensor (Pantelopoulos | Paragraph 0162).
Response to Arguments
Applicant’s arguments and amendments filed 05/04/2026 have been fully considered.
The applicants amendments to claims 9 and 18 have overcome the claim interpretation rejection.
Regarding the 35 U.S.C 103 rejection, the applicant argues Hunt et al. (WO 2020/053290) and Speer et al. (Pediatric Surgery – Chapter 10, Sepsis and Related Considerations, 2012, reference U on PTO-892), whether combined or individually does not teach the following claim limitations: pulsatile signal nor tissue perfusion pressure (TPP). The applicant clarifies the pulsatile signal “is an optical time-series waveform (i.e., the AC component of a PPG signal)” (Remarks Pg. 5) and the specification defines the pulsatile signal as the time-series waveform (Specification Pg. 11). Additionally, the applicant clarifies the tissue perfusion pressure (TPP) is based on “the pressure at which the pulsatile signal disappears or is significantly altered indicates the Tissue Perfusion Pressure (TPP) which is a significant marker of the circulatory health at the location where the probe contacts the patient” (Specification Pg. 4). Because of this, the 35 U.S.C 103 rejection for claims 1-4, 6, 10-13, and 15 being unpatentable over Hunt et al. (WO 2020/053290) in view of Speer et al. (Pediatric Surgery – Chapter 10, Sepsis and Related Considerations, 2012, reference U on PTO-892) is persuasive.
However, the examiner respectfully disagrees with the applicant’s arguments regarding Hunt not teaching the “pulsatile signal” and “tissue perfusion pressure.” Hunt does teach of an “amplitude” of the pulsatile signal through the magnitude of force, which is then used to calculate the tissue perfusion pressure. On page 32, lines 1-2 of Hunt teaches “the recorded [magnitude of] force FSPP can subsequently be used to determine a skin perfusion pressure.” Therefore, the applicant’s argument is not persuasive. Please refer to the 35 U.S.C 102 Rejection for further clarification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SRISTI DIVINA GOMES whose telephone number is (571)272-1356. The examiner can normally be reached Monday-Friday: 9AM to 5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 571-272-3672. 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.
/SRISTI DIVINA GOMES/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
Prosecution Insights