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 .
Response to Arguments
Applicant’s arguments and amendments filed 08/06/2025 have been fully considered.
Regarding the Drawing Objections, the applicant removed the descriptions from the Figures 2, 3, 5, 8-11, and 14 in the amended drawings, and amended the specification to incorporate details regarding data1 through data6 as shown in Figure 14.
Regarding the Claim Objections, the amended claims have overcome the objections for Claims 2-9 and 11-18.
Regarding the Claim Interpretation, the amended claims have not overcome the interpretation because Claims 9 and 18 contain a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. In Claims 9 and 18, the following claim limitations invoke 35 USC 112(f) rejections: "means for applying a force or pressure to the patient" and "the probe held by a fixture."
The applicant’s amendments, see Pages 13-21, filed 08/06/2025, with respect to the rejections of claims 1-7, 9-16, and 18 under 35 USC 103 have been fully considered. Upon further consideration, a new grounds of rejection is made in view of the change in scope of amended claims 1 and 10. the amended claims incorporates the use of a blood circulation sensor to measure an amplitude of a pulsatile signal to calculate a tissue perfusion pressure (TPP) of the patient. The previous set of claims did not incorporate the use of the amplitude of the pulsatile signal to calculate the TPP.
Regarding amended claims 1 and 10, the applicant argues “Hunt does not teach apparatus which comprises a probe having a blood circulation sensor for measuring an amplitude of a pulsatile signal of blood circulating in tissue near a distal tip of the probe when the probe is pressed against the skin of the patient; an apparatus which is configured to (i) apply a varying force or pressure to tissue in which blood is circulating, and (ii) measure an amplitude of a pulsatile signal of blood circulating in tissue near the distal tip of the probe as a force or pressure applied to the tissue is varied; an apparatus which measures the amplitudes of the pulsatile signal of blood circulating in tissue near the distal tip of the probe as the force or pressure applied to the tissue is varied; such measurements to calculate a tissue perfusion pressure (TPP) of the patient.”
Hunt teaches of an apparatus that contains a probe, skin perfusion pressure device – element 804, that contains both a blood circulation sensor, optical sensor – element 877, and a force or pressure sensor, force sensor – element 876. The optical sensor is located at the distal tip, proximal end – element 805, where the probe/apparatus is pressed unto the skin of the patient to measure the pulsatile signal of blood circulation (Figure 8A-B; Page 31, lines 22-34; Page 35, lines 12-14; Page 36 lines 20-22). The combination of the sensor module, the optical sensor and the force sensor, in the probe are pressed unto the patient and measure the pulse amplitude (Page 31, lines 22-34; [Examiner note, one skilled in the art can understand a pulse amplitude and amplitude of a pulsatile signal are the same.]).
Additionally, Hunt teaches a varying force or pressure to the tissue in which blood is circulating through the plunger/spring within the probe. The plunger/spring (plunger – element 810) within the probe allows for the sensor model to have varying force or pressure onto the tissue. (Figures 8M-8T; Page 9, lines 18-25).
Though Hunt is silent in teaching the amplitude of the pulsatile signals are used to calculate a tissue perfusion pressure of the patient. One skilled in the art can understand the values that are used to calculate the pulse amplitude, pulsatile signal, are needed to calculate the tissue perfusion pressure.
In the Pediatric Surgery Textbook, Speer teaches the measured amplitudes of the pulsatile signals are used to calculate a tissue perfusion pressure (TPP) of the patient (Speer | Chapter 10 under section Resuscitation Goals (Page 3 and 9), Perfusion pressure is defined as MAP minus central venous pressure (CVP) or MAP minus intra-abdominal pressure (IAP); [Examiner’s note, one skilled in the art can determine the values from the pulse amplitude are used to calculate the mean arterial pressure (MAP):
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Therefore, the pulse amplitude is required to calculate the mean arterial pressure (MAP). Once the MAP is determined, then one can calculate the TPP.]).
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 calculating the tissue perfusion pressure from Speer. Doing so allows for a physician to treat a patient who is undergoing a medical emergency to bring the patient’s perfusion level to normal (Speer | Table 10-5; Chapter 10 under section Resuscitation Goals (Page 3 and 9)).
Response to Amendment
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Such claim limitation is: "means for applying a force or pressure to the patient" in claims 9 and 18
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is: "the probe held by a fixture" in claims 9 and 18.
Claim 9 and 18 recites “wherein said probe is held by a fixture so that said distal tip contacts a patient and wherein said probe further comprises means for applying a force or pressure to the patient.”
Claims 9 and 18 reciting “said probe is held by a fixture” has been interpreted to invoke 112(f) as a means plus function limitation because of the combination of a non-structural “fixture” and functional language “held by” without reciting sufficient structure to achieve the claimed function.
Claims 9 and 18 reciting “means for applying a force or pressure to the patient” has been interpreted under 112f as a means plus function limitation because of the combination of the use of the term “means for” and functional language “applying a force or pressure to the patient” without reciting sufficient structure to achieve the function.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Figure 13 illustrate an example of how the probe may be mounted to a fixture. In page 2, (Lines 4-6 in Paragraph 2), “the device is a handheld probe (or fixture mounted probe).” Therefore, the evidence presented depict sufficient structure to define the “the probe is held by a fixture” because the probe can be a handle device or the probe can be mounted to a fixture.
Figures 9 and 10 illustrate examples of the probe applying a force or pressure to the patient. Additionally, “the operator holds the other cylindrical structure, which has a force or pressure sensor, and is able to apply pressure to the patient” (Page 4, Paragraph 1, Lines 5-7). Therefore, the figures and the job of the operator depicts sufficient structure to define the “means for applying a force or pressure to the patient” because they show how the probe applies force or pressure to the patient.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-4, 6, 10-13, and 15 are rejected under 35 U.S.C. 103 as 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).
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 (proximal end – element 805; Page 35, lines 12-14; [Examiner note, an optical sensor is communicating with the proximal end, the distal tip, to receive a blood circulation measurement. The sensor module is performing the diagnostic measurement of blood circulation.]);
said probe having a blood circulation sensor (optical sensor – element 877) for measuring an amplitude of a pulsatile signal of blood circulating 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.]);
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 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; [Examiner note, one skilled in the art can understand a pulse amplitude and amplitude of a pulsatile signal are the same.]).
Hunt is silent in disclosing the amplitude of the pulsatile signals are used to calculate a tissue perfusion pressure of the patient;
Speer teaches, in the Pediatric Surgery Textbook, the measured amplitudes of the pulsatile signals are used to calculate a tissue perfusion pressure (TPP) of the patient (Speer | Chapter 10 under section Resuscitation Goals (Page 3 and 9), Perfusion pressure is defined as MAP minus central venous pressure (CVP) or MAP minus intra-abdominal pressure (IAP); [Examiner’s note, one skilled in the art can determine the values from the pulse amplitude are used to calculate the MAP:
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Therefore, the pulse amplitude is required to calculate the mean arterial pressure (MAP). Once the MAP is determined, then one can calculate the TPP.]).
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 calculating the tissue perfusion pressure from Speer. Doing so allows for a physician to treat a patient who is undergoing a medical emergency to bring the patient’s perfusion level to normal (Speer | Table 10-5; Chapter 10 under section Resuscitation Goals (Page 3 and 9)).
Regarding Claim 2, Hunt in view of Speer teaches 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 the gradual force or pressure applied to the patient.]).
Regarding Claim 3, Hunt in view of Speer 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 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; [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.]).
Regarding Claim 4, Hunt in view of Speer teaches an apparatus according to claim 1. However, Hunt in view of Speer 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 Speer 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 6, Hunt in view of Speer teaches an apparatus according to claim 1, wherein said probe (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 (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 (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 (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 (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 10, Hunt discloses a method for performing a diagnostic measurement of blood circulation in a patient, 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 (proximal end – element 805; Page 35, lines 12-14; [Examiner note, an optical sensor is communicating with the proximal end, the distal tip, to receive a blood circulation measurement. The sensor module is performing the diagnostic measurement of blood circulation.]);
said probe having a blood circulation sensor (optical sensor – element 877) for measuring an amplitude of a pulsatile signal of blood circulating 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 in tissue near said distal tip of said probe (Page 31, lines 22-34; [Examiner note, one skilled in the art can understand a pulse amplitude and amplitude of a pulsatile signal are the same.]);
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 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; [Examiner note, one skilled in the art can understand a pulse amplitude and amplitude of a pulsatile signal are the same.]).
Hunt is silent in disclosing the amplitude of the pulsatile signals are used to calculate a tissue perfusion pressure of the patient;
Speer teaches, in the Pediatric Surgery Textbook, the measured amplitudes of the pulsatile signals are used to calculate a tissue perfusion pressure (TPP) of the patient (Speer | Chapter 10 under section Resuscitation Goals (Page 3 and 9), Perfusion pressure is defined as MAP minus central venous pressure (CVP) or MAP minus intra-abdominal pressure (IAP); [Examiner’s note, one skilled in the art can determine the values from the pulse amplitude are used to calculate the MAP:
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Therefore, the pulse amplitude is required to calculate the mean arterial pressure (MAP). Once the MAP is determined, then one can calculate the TPP.]).
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 calculating the tissue perfusion pressure from Speer. Doing so allows for a physician to treat a patient who is undergoing a medical emergency to bring the patient’s perfusion level to normal (Speer | Table 10-5; Chapter 10 under section Resuscitation Goals (Page 3 and 9)).
Regarding Claim 11, Hunt in view of Speer teaches 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 in view of Speer teaches 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 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; [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.]).
Regarding Claim 13, Hunt in view of Speer teaches a method according to claim 10. However, Hunt in view of Speer 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 Speer 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 15, Hunt in view of Speer teaches a method according to claim 10, wherein said probe (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 (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 (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 (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 (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]).
Claims 5, 7, 9, 14, 16, and 18 are rejected under 35 U.S.C. 103 as 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) and Pantelopoulos et al. (US 20170209055 A1).
Regarding Claim 5, Hunt in view of Speer teaches an apparatus according to claim 4. However, Hunt in view of Speer 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 Speer 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 in view of Speer 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 in view of Speer 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 (Pantelopolous | 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 in view of Speer teaches 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 in view of Speer 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 in view of Speer 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 (Pantelopolous | Paragraph 0162).
Regarding Claim 9, Hunt in view of Speer teaches an apparatus according to claim 1, wherein said probe (Hunt | skin perfusion pressure determination device – element 804) is held by a fixture (Hunt | spring – element 811) and wherein said probe further comprises means for applying a force or pressure to the patient (Hunt | Page 36 lines 9-10, the spring 811 can be used to control the force applied to and/or withdrawn from the target area; [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]).
Though it can be inferred the probe’s distal tip is held by a fixture which has contact with the patient, Hunt in view of Speer does not explicitly teach the probe is held by a fixture so that the said distal tip contacts a patient;
Pantelopoulos teaches the probe (Pantelopoulos | biometric monitoring device) is held by a fixture so the tip contacts a patient (Pantelopoulos | Paragraph 0162, the wearable biometric monitoring device also includes a pressure sensor that can be used to measure the pressure between the sensor and the user's tissue, which can affect the features and dynamics of the pulse wave; Figure 14 [illustrates the biometric monitoring device is fixed on the user’s wrist]; Figures 11B-C and 12 [Examiner note, illustrates the biometric monitoring device having a protrusion on the back side of the device, where it has contact with the user’s skin, the photodetectors are then used to read various blood circulation measurements from the user.]).
One having an ordinary skill in the art the time the invention was filed would have found it obvious to substitute the skin perfusion pressure determination device of Hunt in view of Speer to incorporate the teachings of the probe being held by a fixture so the tip contacts a patient from Pantelopoulos because Pantelopolous teaches in Paragraph 0130, biometric monitoring device having: (a) a wearable fixing structure configured to attach to a user and/or a user's apparel in a manner allowing the user to wear the biometric monitoring device while performing activities. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Regarding Claim 14, Hunt in view of