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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 1, the claim(s) recites “a control processor to generate a blood pressure output signal based on the detection output signal and calibration data, the calibration data associating blood volume to blood pressure for the user and accounting for the holding force.” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“an illumination subsystem to project illumination through a body part that includes at least one elastic blood circulatory pathway through which flows a continuously changing volume of blood, the illumination being at a frequency absorbed by blood;”
“an optical detection subsystem to receive portions of the illumination passing through the body part without absorption or reflection, and to generate a detection output signal based on the received portions of the illumination to correspond to the continuously changing volume of blood;”
“a portable housing by which to hold at least one of the illumination subsystem or the optical detection subsystem against the body part with a holding force during a measurement routine including illumination and optical detection;”
“a pressure detection subsystem integrated with the portable housing to monitor the holding force during the measurement routine;”
“wherein generating the blood pressure output signal by the control processor comprises generating a systolic blood pressure reading and a diastolic blood pressure reading, and a difference between the systolic blood pressure reading and the diastolic blood pressure is associated with a difference between a diastolic peak signal level of the detection output signal and a systolic trough signal level of the detection output signal.”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities.
Furthermore, illumination subsystems, optical detection subsystems, and pressure detection subsystems are general fields of use and control processors are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of receiving a transmitted light signal, applying calibration data to the received light signal, and predicting blood pressure from this application and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself.
Dependent claims 2-15 also do not recite patent eligible subject matter as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Regarding Claim 16, the claim(s) recites “generating a blood pressure output signal based on the detection output signal and calibration data, the calibration data associating blood volume to blood pressure for the user and accounting for the holding force” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“receiving a measurement trigger signal by a control processor of the portable electronic device to perform a measurement routine to measure a blood pressure of a user;
executing the measurement routine by the control processor responsive to the measurement trigger signal by:
directing projecting of illumination through a body part that includes at least one elastic blood circulatory pathway through which flows a continuously changing volume of blood, the illumination being at a frequency absorbed by blood;
directing generating of a detection output signal responsive to receiving portions of the illumination passing through the body part without absorption or reflection, such that the detection output signal corresponds to the continuously changing volume of blood;
directing monitoring a holding force being applied to the body part during the directing projecting and the directing generating;”
“wherein generating the blood pressure output signal by the control processor comprises generating a systolic blood pressure reading and a diastolic blood pressure reading, and a difference between the systolic blood pressure reading and the diastolic blood pressure is associated with a difference between a diastolic peak signal level of the detection output signal and a systolic trough signal level of the detection output signal.”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities.
Furthermore, control processors are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of receiving a transmitted light signal, applying calibration data to the received light signal, and predicting blood pressure from this application and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself.
Dependent claims 17-20 also do not recite patent eligible subject matter as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
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(s) 1-4, 10-14, and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark et al (US 5,423,322) (“Clark”) in view of Mukkamala et al (US 2019/0008399) (“Mukkamala”) and further in view of Banet et al (US 2006/0122520) (“Banet”).
Regarding Claim 1, while Clark teaches a system for non-invasive measurement of blood pressure of a user (Abstract, Figs. 1 and 4), the system comprising:
an illumination subsystem to project illumination through a body part that includes at least one elastic blood circulatory pathway through which flows a continuously changing volume of blood (Fig. 4, Col. 12, L. 25-43, Led 120 / illumination subsystem, Col. 14, L. 42 – Col. 15, L. 27, to project illumination through a body part / finger 10 that includes at least one elastic blood circulatory pathway through which flows a continuously changing volume of blood) the illumination being at a frequency absorbed by blood (col. 4 line 52, light absorbed detected; Col. 14, L. 42 – Col. 15, L. 27, light not absorbed, so there is light that is absorbed);
an optical detection subsystem to receive portions of the illumination passing through the body part without absorption or reflection (Fig. 4, Col. 14, L. 42 – Col. 15, L. 27, photo-detector 122, DC filter amp 112, AC filter amp 114 / optical detection subsystem receives light “transmitted through the finger 10 and the light which is not absorbed by the body part is received by the photo-detector 122.”), and to generate a detection output signal based on the received portions of the illumination to correspond to the continuously changing volume of blood (Col. 12, L. 25-43, “the incident light "beam" (I represented by line 124) of the LED 120 passes through the finger, generally designated at 10, to produce a time variant transmission light (I(t)) due to essentially arterial volume variation.“);
a housing by which to hold at least one of the illumination subsystem or the optical detection subsystem against the body part with a holding force during a measurement routine including illumination and optical detection (Fig. 4, Col. 14, L. 42 – Col. 15, L. 27, finger cuff 116);
a pressure detection subsystem integrated with the housing to monitor the holding force during the measurement routine (Fig. 4, Col. 15, L 6-65, pressure transducer 110 integrated with finger cuff to monitoring the holding force applied by the cuff during the measurement routine); and
a control processor to generate a blood pressure output signal based on the detection output signal and calibration data (Col. 15, L 6-65, processor 102 generates blood pressure output signal by initially finding unknowns for a compliance model with application of a ramped holding force with simultaneously monitored PPG data), the calibration data associating blood volume to blood pressure for the user and accounting for the holding force (Col. 18, L. 11 – Col. 19, L. 27), wherein generating the blood pressure output signal by the control processor comprises generating a systolic blood pressure reading and a diastolic blood pressure reading, and a difference between the systolic blood pressure reading and the diastolic blood pressure is associated with a difference between a diastolic peak signal level of the detection output signal and a systolic trough signal level of the detection output signal (Figs. 4, 7-8, AC volume signal from transmissive PPG is characterized by systolic points 176 and diastolic points 174, these enabling finding of blood pressure and Col. 8, Equations 9-11 provides a direction association between differences in systolic and diastolic volumes and systolic and diastolic pressure), Clark fails to teach the system providing controlled holding force is cuff-less and the housing being a portable housing.
However Mukkamala teaches a blood pressure measuring device (Abstract) comprising determining blood pressure by a transmissive optical sensing, where a pressure detection subsystem is integrated with the PPG sensor in a ring, and pressing force is modulated without the use of a cuff ([0091]), where various system housings are portable ([0042], [0088], [0097] system can be applied as watch, smartwatch, wristband, or other wearable / portable electronic device) and Banet teaches a blood pressure detection device (Abstract) utilizing transmissive-type PPG in a ring sensor to identify blood pressure from the optical data ([0020]) and further teaches the system utilizing a singular portable housing comprising a ring component and wrist worn component ([0026]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the cuff-based pressing force detection system of Clark could be substituted with a cuffless-based pressing force detection system of Mukkamala as a simple substitution of one from of modulating the force on a blood vessel (Clark: with a controlled inflation of a cuff) for another (Mukkamala: with a controlled push by a finger) to obtain predictable results of identification of data variation in light and pressure, enabling one to solve for unknowns in a compliance model. Furthermore, it would have been obvious to integrate the system of Clark into a portable housing as taught by Mukkamala to increase user convenience. And while, Mukkamala does not give an explicit description of how a transmission-utilizing ring PPG sensor would be applied with a portable housing, such devices were known in the art (Banet: [0026] optical-based vital sign monitor where the optical detection is done at a ring connected to a wrist-housing, enabling the system as a whole to be portable, [0022] uses transmitted portions of light for detection purposes).
Regarding Claim 2, Clark, Mukkamala, and Banet teach the system of claim 1, and Clark teaches the use of an interface subsystem to output the systolic blood pressure reading and the diastolic blood pressure reading (Fig. 4, Col. 19, L. 59-65, display) and Mukkamala teaches a second embodiment comprising:
an interface subsystem integrated with a portable housing and coupled with a control processor to output the systolic blood pressure reading and the diastolic blood pressure reading (Fig. 13, [0089]-[0091], [0096]-[0097] a wearable embodiment of the system includes a display and wearables may include necessary components for display and processing, which includes a processor), their combined efforts fail to explicitly teach utilizing an interface subsystem with a wearable ring.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the wearable watch with a display taught by Mukkamala may be integrated into a display of a wearable ring taught by Mukkamala to extend the same self-contained functionality of the watch to the ring of Clark and Mukkamala.
Regarding Claim 3, Clark, Mukkamala, and Banet teach the system of claim 2, wherein the interface subsystem comprises a human-readable display to visually output the systolic blood pressure reading and the diastolic blood pressure reading (See Claim 2 Rejection).
Regarding Claim 4, Clark, Mukkamala, and Banet teach the system of claim 1, and Clark teaches the system further comprising: a calibration memory having calibration data stored thereon (Col. 15, L 6-65, Col. 20, L. 23-29, data and computations are collected and stored within the processor, which will include the identified constants particular to a patient, and values found for particular holding pressures. This data can be understood as calibration data).
Regarding Claim 10, Clark, Mukkamala, and Banet teach the system of claim 1, wherein the portable housing is to hold the illumination subsystem on a first side of the body part, to hold the optical detection subsystem on a second side of the body part opposite the first side, and to orient the illumination subsystem to project the illumination through the body part at least in a direction of the optical detection subsystem (See Claim 1 Rejection, Clark’s finger-based system in Fig. 4 has this configuration, made portable in view of Mukkamala and Banet’s teachings).
Regarding Claim 11, Clark, Mukkamala, and Banet teach the system of claim 10, wherein the portable housing comprises a ring- shaped structure to fully surround the body part such that the illumination subsystem is held on the first side of the body part, the optical detection subsystem is held on the second side of the body part opposite the first side, and the illumination subsystem is oriented to project the illumination through the body part at least in the direction of the optical detection subsystem (See Claim 10 Rejection, Clark’s finger-based system in Fig. 4 has this configuration, made portable in view of Mukkamala and Banet’s teachings).
Regarding Claim 12, Clark, Mukkamala, and Banet teach the system of claim 10, wherein the portable housing comprises a half-open structure to partially surround the body part such that the illumination subsystem is held on the first side of the body part, the optical detection subsystem is held on the second side of the body part opposite the first side, and the illumination subsystem is oriented to project the illumination through the body part at least in the direction of the optical detection subsystem (See Claim 10 Rejection¸ Mukkamala notes a transmission PPG sensing can be performed with a clothespin format, a clothespin format applied to the finger-based system of Clark would lead to a half-open structure to partially surround the body part such that the illumination subsystem is held on the first side of the body part, the optical detection subsystem is held on the second side of the body part opposite the first side. Specifically, the sides of the clothespin are open so that the finger is only partially surrounded).
Regarding Claim 13, Clark, Mukkamala, and Banet teach the system of claim 10, wherein the portable housing comprises a clip-shaped structure to clip onto the body part such that the illumination subsystem is held on the first side of the body part, the optical detection subsystem is held on the second side of the body part opposite the first side, and the illumination subsystem is oriented to project the illumination through the body part at least in the direction of the optical detection subsystem (See Claim 10 Rejection¸ Mukkamala notes a transmission PPG sensing can be performed with a clothespin format, a clothespin format applied to the finger-based system of Clark would be a clip-shaped structure to clip onto the body part such that the illumination subsystem is held on the first side of the body part and the optical detection subsystem is held on the second side of the body part opposite the first side).
Regarding Claim 14, while Clark, Mukkamala, and Banet teach the system of claim 1, wherein the control processor is integrated within the portable housing and is coupled with the illumination subsystem, the optical detection subsystem, and the pressure detection subsystem (See Claim 1 Rejection, Examiner interprets the ring and wrist-structure of Banet as a whole as the portable housing, thus indicating a microprocessor 32 can be integrated within the portable housing, applying to the processor of Clark).
Regarding Claim 17, while Clark teaches a method for non-invasive measurement of blood pressure of a user using an electronic device (Abstract, Figs. 1, 4, and 6), the method comprising:
receiving a measurement trigger signal by a control processor of the electronic device to perform a measurement routine to measure blood pressure of a user (Figs. 4 and 6, Col. 17, L. 39-52, measurement routine performed by the processor, necessarily will require a measurement trigger signal);
executing the measurement routine by the control processor (Fig. 4 and 6, Col. 17, L. 39-52, measurement routine performed by the processor, necessarily will require a measurement trigger signal) responsive to the measurement trigger signal by:
directing projecting of illumination through a body part that includes at least one elastic blood circulatory pathway through which flows a continuously changing volume of blood, the illumination being at a frequency absorbed by blood (Fig. 4, Col. 12, L. 25-43, Led 120 / illumination subsystem, Col. 14, L. 42 – Col. 15, L. 27, to project illumination through a body part / finger 10 that includes at least one elastic blood circulatory pathway through which flows a continuously changing volume of blood, Col. 12, L. 25-43, illumination at frequency corresponding to red light);
directing generating of a detection output signal responsive to receiving portions of the illumination passing through the body part without absorption or reflection (Fig. 4, Col. 14, L. 42 – Col. 15, L. 27, photo-detector 122, DC filter amp 112, AC filter amp 114 / optical detection subsystem receives light “transmitted through the finger 10 and the light which is not absorbed by the body part is received by the photo-detector 122.”), such that the detection output signal corresponds to the continuously changing volume of blood (Col. 12, L. 25-43, “the incident light "beam" (I represented by line 124) of the LED 120 passes through the finger, generally designated at 10, to produce a time variant transmission light (I(t)) due to essentially arterial volume variation.“);
directing monitoring a holding force being applied to the body part during the directing projecting and the directing generating (Fig. 4, Col. 15, L 6-65, pressure transducer 110 integrated with finger cuff to monitoring the holding force applied by the cuff during the measurement routine);
generating a blood pressure output signal based on the detection output signal and calibration data (Col. 15, L 6-65, processor 102 generates blood pressure output signal by initially finding unknowns for a compliance model with application of a ramped holding force with simultaneously monitored PPG data), the calibration data associating blood volume to blood pressure for the user and accounting for the holding force (Col. 18, L. 11 – Col. 19, L. 27), wherein generating the blood pressure output signal by the control processor comprises generating a systolic blood pressure reading and a diastolic blood pressure reading, and a difference between the systolic blood pressure reading and the diastolic blood pressure is associated with a difference between a diastolic peak signal level of the detection output signal and a systolic trough signal level of the detection output signal (Figs. 4, 7-8, AC volume signal from transmissive PPG is characterized by systolic points 176 and diastolic points 174, these enabling finding of blood pressure and Col. 8, Equations 9-11 provides a direction association between differences in systolic and diastolic volumes and systolic and diastolic pressure), Clark fails to teach the system providing controlled holding force is cuff-less and the electronic device is a portable electronic device;
However Mukkamala teaches a blood pressure measuring device (Abstract) comprising determining blood pressure by a transmissive optical sensing, where a pressure detection subsystem is integrated with the PPG sensor in a ring, and pressing force is modulated without the use of a cuff ([0091]), where various system housings are portable ([0042], [0088], [0097] system can be applied as watch, smartwatch, wristband, or other wearable / portable electronic device) and Banet teaches a blood pressure detection device (Abstract) utilizing transmissive-type PPG in a ring sensor to identify blood pressure from the optical data ([0020]) and further teaches the system utilizing a singular portable housing comprising a ring component and wrist worn component ([0026]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the cuff-based pressing force detection system of Clark could be substituted with a cuffless-based pressing force detection system of Mukkamala as a simple substitution of one from of modulating the force on a blood vessel (Clark: with a controlled inflation of a cuff) for another (Mukkamala: with a controlled push by a finger) to obtain predictable results of identification of data variation in light and pressure, enabling one to solve for unknowns in a compliance model. Furthermore, it would have been obvious to integrate the system of Clark into a portable housing as taught by Mukkamala to increase user convenience. And while, Mukkamala does not give an explicit description of how a transmission-utilizing ring PPG sensor would be applied with a portable housing, such devices were known in the art (Banet: [0026] optical-based vital sign monitor where the optical detection is done at a ring connected to a wrist-housing, enabling the system as a whole to be portable, [0022] uses transmitted portions of light for detection purposes).
Regarding Claim 18, Clark, Mukkamala, and Banet teach the method of claim 17, and Clark teaches the use of an interface subsystem to output the systolic blood pressure reading and the diastolic blood pressure reading (Fig. 4, Col. 19, L. 59-65, display) and Mukkamala teaches a second embodiment comprising:
an interface subsystem integrated with a portable housing and coupled with a control processor to output the systolic blood pressure reading and the diastolic blood pressure reading (Fig. 13, [0089]-[0091], [0096]-[0097] a wearable embodiment of the system includes a display and wearables may include necessary components for display and processing, which includes a processor), their combined efforts fail to explicitly teach utilizing an interface subsystem with a wearable ring.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the wearable watch with a display taught by Mukkamala may be integrated into a display of a wearable ring taught by Mukkamala to extend the same self-contained functionality of the watch to the ring of Clark, Mukkamala, and Banet.
Claim(s) 5-6, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark in view of Mukkamala and further in view of Banet and further in view of Russell (US 2015/0099943).
Regarding Claim 5, while Clark, Mukkamala, and Banet teach the system of claim 1, and Mukkamala teaches utilizing a set of illumination sources ([0093]), and Banet teaches a set of illumination sources each to project the illumination through the body part and directed toward the detection subsystem (Figs. 3A-4, [0021], [0023]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the system of Clark utilize multiple sets of illumination sources and photodetectors as taught by Banet as Banet teaches that averaging different sets of illumination sources and photodetectors corrects for motion artifact.
Yet their combined efforts fail to teach wherein the illumination subsystem comprises an illumination spreader to increase a uniformity of illumination distribution from the set of illumination sources over an illumination region of the body part.
However Russell teaches a system for non-invasive cuff-less measurement of blood pressure of a user (Abstract, Fig. 2), the system comprising:
an illumination subsystem to project illumination through a body part (Fig. 2, [0034]- [0037] the illumination subsystem comprises a light source 220, a plurality of light pipes 225, and multiple transmitting apertures 245, the plurality of light pipes directing light into and through the extremity to the second light pipe 230) that includes at least one elastic blood circulatory pathway through which flows a continuously changing volume of blood ([0043] patient vasculature 215 where the various light pipes ensure that some of the patient vasculature is appropriately measured), the illumination being at a frequency absorbed by blood ([0035] infrared and near infrared light);
wherein the illumination subsystem comprises:
an illumination spreader ([0037] diffusion lenses 240 spread illumination through the transmitting apertures 245) to increase a uniformity of illumination distribution from the set of illumination sources over an illumination region of the body part (Examiner notes that as a system claim, this aspect of the illumination spreader is intended use).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the set of illumination sources of Clark, Mukkamala, and Russell to utilize an illumination spreader as taught by Russell as a way to control how light is transmitted through the body part and achieve a desired spread of light for detection at the opposite end of the body part.
Regarding Claim 6, Clark, Mukkamala, Banet, and Russell teach the system of claim 5, wherein the illumination spreader comprises a diffuser material (See Claim 5 Rejection, the diffusion lenses are considered a diffusion material).
Regarding Claim 9, Clark, Mukkamala, Banet, and Russell teach the system of claim 1, and Mukkamala teaches utilizing a set of photodetectors ([0096]), and Banet teaches a set of photodetectors to generate the detection output signal in response to exposure to the received portions of the illumination (Figs. 3A-4, [0021], [0023]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the system of Clark utilize multiple sets of illumination sources and photodetectors as taught by Banet as Banet teaches that averaging different sets of illumination sources and photodetectors corrects for motion artifact.
Yet their combined efforts fail to teach wherein the optical detection subsystem comprises:
a receiving aperture to direct the received portions of the illumination onto the set of photodetectors.
However Russell teaches a system for non-invasive cuff-less measurement of blood pressure of a user (Abstract, Fig. 2), the system comprising:
an optical detection subsystem to receive portions of the illumination passing through the body part without absorption or reflection (Fig. 2, [0034]-[0037] optical detection subsystem comprises an optical receiver 235, a plurality of second light pipes 230, and receiving apertures 250 [0043] bone 210 or muscle 205 will interact with light in an undesired way and shows a desired transmissive path from arrows without absorption or reflection), and to generate a detection output signal based on the received portions of the illumination to correspond to the continuously changing volume of blood ([0043] “The optical receiver 235 may receive the light and may output one or more signals representative of the received light. The processor 285 may then determine one or more physiological parameters of the patient based, at least in part, on the one or more signals outputted from the optical receiver 235.” [0023] blood flow may be a parameter obtained from optical data, the blood flow corresponds to continuously changing volume of blood);
wherein the optical detection subsystem comprises:
a receiving aperture to direct the received portions of the illumination onto the set of photodetectors (Fig. 2, [0037] receiving apertures 250).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the set of photodetectors of Clark, Mukkamala, and Russell to utilize a receiving aperture as taught by Russell as a way to control how light is received through the body part and achieve a desired detection at the opposite end of the body part from the illumination sources.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark in view of Mukkamala and further in view of Banet and further in view of Russell and further in view of Asada et al (US 2007/0055163) (“Asada”).
Regarding Claim 7, while Clark, Mukkamala, Banet, and Russell the system of claim 5, and Russell further teaches wherein the illumination spreader comprises:
a spacing structure to hold the set of illumination sources a distance away from the illumination region of the body part (Fig. 2, [0034]-[0035] the structure of the wearable sensing device spaces the illumination sources apart from the body with the light being transmitted to the body by the diffusion lenses 240 and transmitting apertures 245).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the optical emission and detection of Clark, Mukkamala, Banet, and Russell to utilize light pipes, apertures, and the spacing teachings taught by Russell as a way to provide greater control over how light is received through the body part.
Yet their combined efforts fail to teach a shielding structure to shield the illumination region of the body part from ambient illumination.
However Asada teaches a wearable blood pressure sensor (Abstract) utilizing a cuff-less embodiment with an illumination subsystem and an optical detection subsystem (Fig. 14, [0124]-[0125]), further teaches applying a shielding structure to shield the sensing components from ambient illumination, where the sensing components enclose the illumination region (Fig. 8, [0121] outer casing can be used to protect the PPG sensor from ambient light), their combined efforts fail to explicitly teach the illumination spreader comprising the shielding structure.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the illumination spreader of Russell to include a shielding structure as taught by Asada to provide the ambient light protection to the sensing routine of Russell, ensuring more accurate optical-based parameters.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark in view of Mukkamala and further in view of Banet and further in view of Russell and further in view of Rabinovich et al (US 2018/0184920) (“Rabinovich”).
Regarding Claim 8, while Clark, Mukkamala, Banet, and Russell teach the system of claim 5, and Russell further teaches wherein:
the illumination subsystem further comprises an illumination monitor to monitor an illumination output of a single illumination source ([0047]-[0048] optical receiver 305 acts as an illumination monitor of the light of the first light source 220-a); and
the control processor is in communication with the illumination subsystem to generate a corrective action responsive to the monitoring by the illumination monitor indicating that the illumination output fails to satisfy a predetermined acceptance criteria ([0047]-[0048] judging optical losses from light pipe material or optical defects from the illumination monitoring), wherein the illumination sources is a set of illumination sources (See Claim 5 Rejection), their combined efforts fail to teach the illumination monitor to monitor an illumination output of the set of illumination sources; and
the control processor is in communication with the illumination subsystem to generate an illumination warning signal responsive to the monitoring by the illumination monitor indicating that the illumination output fails to satisfy a predetermined acceptance criteria.
However Rabinovich teaches a wearable blood pressure sensor (Abstract) where blood pressure measurement is attempted, and the control processor generates a warning signal responsive to the monitoring of the measurement indicating that the data fails to satisfy a predetermined acceptance criteria (Fig. 10, [0101]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the illumination monitor of Clark, Mukkamala, Banet, and Russell identify whether an illumination is providing a sufficient transmission of light to predict blood pressure as Rabinovich teaches that a wearable blood pressure sensor can identify whether the system is gathering suitable data so that user feedback can be provided. Thus, when considering Rabinovich’s teachings applied to Clark, Mukkamala, Banet, and Russell, one could identify whether the illumination being monitored in Russell is sufficient to calculate blood pressure so that a warning signal may be initiated, if predetermined criteria shows that a calibration factor would not be sufficient to get a desired blood pressure measurement (i.e. the LED malfunctions and insufficient light is output). Finally, it would have been obvious to judge the plurality of light sources, individualized for specific wavelengths of light to identify if any of the light sources were providing light in a manner unsuitable for monitoring.
Regarding Claim 19, while Clark, Mukkamala, and Banet teach the method of claim 17, their combined efforts fail to teach the method further comprising:
directing monitoring of an illumination output being projected through the body part during the directing projecting.
However Russell teaches a system for non-invasive cuff-less measurement of blood pressure of a user (Abstract, Fig. 2), comprising directing monitoring of an illumination output being projected through the body part during the directing projecting ([0047]-[0048] illumination monitored by optical receiver 305, said illumination will also be projected through the body part).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the illumination of Clark, Mukkamala, Banet monitored as taught by Russell to provide contextual data in the case that the output volume data is in an irregular range.
Yet their combined efforts fail to teach generating an illumination warning signal responsive to the directing monitoring indicating that the illumination output fails to satisfy a predetermined acceptance criteria.
However Rabinovich teaches a wearable blood pressure sensor (Abstract) where blood pressure measurement is attempted, and the control processor will generate a warning signal responsive to the monitoring of the measurement indicating that the data fails to satisfy a predetermined acceptance criteria (Fig. 10, [0101]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the illumination monitor of Clark, Mukkamala, Banet, and Russell identify whether an illumination is providing a sufficient transmission of light to predict blood pressure as Rabinovich teaches that a wearable blood pressure sensor can identify whether the system is gathering suitable data so that user feedback can be provided. Thus, when considering Rabinovich’s teachings applied to Clark, Mukkamala, Banet, and Russell, one could identify whether the illumination being monitored in Russell is sufficient to calculate blood pressure so that a warning signal may be initiated, if predetermined criteria shows that a calibration factor would not be sufficient to get a desired blood pressure measurement (i.e. the LED malfunctions and insufficient light is output). Finally, it would have been obvious to judge the plurality of light sources, individualized for specific wavelengths of light to identify if any of the light sources were providing light in a manner unsuitable for monitoring.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark in view of Mukkamala and further in view of Banet and further in view of Asada and further in view of Takatani et al (US 4,867,557) (“Takatani”).
Regarding Claim 15, while Clark, Mukkamala, and Banet teach the system of claim 1, and Clark teaches wherein the control processor is configured to operate in a measurement mode or a calibration mode (Fig. 6, Col. 19, L. 59 – Col. 20, L. 29, calibration mode corresponds to steps 150-160, measurements mode corresponds to steps 162 and 164), such that
in the measurement mode, the control processor is to perform the measurement routine to generate the blood pressure output signal based on the detection output signal and the calibration data (See Claim 1 Rejection, Col. 19, L. 59 – Col. 20, L. 29); and
in the calibration mode, the control processor is to perform a calibration routine to generate and store the calibration data for each of a plurality of calibration conditions corresponding to a respective pressure application of the portable housing
generating at least one detection output signal by the optical detection subsystem, responsive to projecting the illumination by an illumination subsystem with the housing in a placement, to obtain at least one calibration blood volume measurement;
obtaining at least one pre-calibrated blood pressure reading; and
updating the calibration data based on computing a relationship between the at least one calibration blood volume measurement to the at least one pre-calibrated blood pressure reading from the calibration condition (See Claim 1 Rejection, Col. 19, L. 466529, pressure values and model parameters are considered and error information in pressure values identified over time, indicating the obtaining of blood pressure readings from which errors can be identified), and further teaches obtaining reference blood pressure readings from a separate measurement device (Fig. 10, Col. 21, L. 10-30).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to utilize a separate measurement device, such as a direct arterial line, to obtain reference pre-calibrated blood pressure measurements as taught by Clark as this facilitates the reduction in error of a generated compliance model, which may then be utilized in a continuous, non-invasive manner.
Yet their combined efforts fail to teach
selective operation of the measurement mode or calibration mode; and
the plurality of calibration conditions corresponding to a respective placement of the portable housing.
However Asada teaches a calibration mode ([0063]-[0070]) such that:
in the calibration mode, the control processor is to perform a calibration routine to generate and store the calibration data for each of a plurality of calibration conditions corresponding to a respective placement of the portable housing ([0066]-[0070] once a respective placement is chosen, a calibration routine is followed) by:
generating at least one detection output signal by the optical detection subsystem, responsive to projecting the illumination by an illumination subsystem with the housing in the respective placement, to obtain at least one respective calibration blood volume measurement ([0063]-[0070] PPG signal amplitude measured at multiple heights, with a constant external pressures / holding force);
updating the calibration data based on computing a relationship between the at least one calibration blood volume measurement for the calibration condition ([0069]-[0070] relationship between PPG and arterial blood pressure captured by calibration considering height, cuff pressure, and PPG data),
and teaches a second embodiment obtaining at least one pre-calibrated blood pressure reading from a separate measurement device ([0079] a separate conventional inflatable cuff used to provide pre-calibrated blood pressure readings) where the blood pressure relationship with PPG is identified by a separate measurement device and the at least one pre-calibrated blood pressure reading ([0079] “The prediction of ABP from a PPG signal can also be performed, within the scope of the present invention, when PPG signal is calibrated by a different device, including a convention inflatable cuff placed at the level of the brachial artery.”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to perform the placement-based calibration steps of the first embodiment of Asada for the optical-based pressure sensor of Clark, Mukkamala, and Banet to identify how the PPG and arterial blood pressure relationship may be predicted for different conditions.
Yet their combined efforts fail to teach wherein the control processor is configured selectively to operate in one of a measurement mode or a calibration mode.
However Takatani teaches a optical-based sensor for evaluation cardiovascular parameters (Abstract) where the system may selectively be placed in a measurement mode or a calibration mode (Col. 3, L. 15-20).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the processor of Russell configured selectively to operate in one of a measurement mode of Russell or a calibration mode of Asada as taught by Takatani so one can recalibrate as is necessary and then gather results after recalibration by being placed in the measurement mode.
Regarding Claim 16, Clark, Mukkamala, Banet, Asada, and Takatani teach the system of claim 15, wherein the control processor is to perform the calibration routine, for each of the plurality of calibration conditions, further by:
obtaining a respective calibration holding force measurement from the pressure detection subsystem,
wherein the computing the relationship accounts for the respective calibration holding force measurement (See Claim 15 Rejection, Clark and Mukkamala’s calibration routine accounts for holding force).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark in view of Mukkamala and further in view of Banet and further in view of Asada.
Regarding Claim 20, while Clark, Mukkamala, and Banet teach the method of claim 17, further comprising:
Receiving a calibration trigger signal by the control processor to perform a calibration routine to generate and store the calibration data for the portable electronic device and the user (See Claim 17 Rejection, Fig. 6, Col. 19, L. 59 – Col. 20, L. 29, calibration mode corresponds to steps 150-160, thus when measurement routine is started, the calibration is triggered as well);
Executing the calibration routine by the control processor responsive to the calibration trigger signal by, for each of a plurality of calibration conditions corresponding to a respective pressure application of the portable electronic device, while having a reference blood pressure reading;
Directing projecting calibration illumination through the body part;
Directing generating a calibration detection output signal responsive to projecting the calibration illumination to obtain at least one respective calibration blood volume measurement; and
updating the calibration data based on computing a relationship between the at least one calibration blood volume measurement to the at least one pre-calibrated blood pressure reading from the calibration condition (See Claim 17 Rejection, Col. 19, L. 45 – 65, pressure values and model parameters are considered and error information in pressure values identified over time, indicating the obtaining of blood pressure readings from which errors can be identified), and further teaches obtaining reference blood pressure readings from a separate measurement device (Fig. 10, Col. 21, L. 10-30).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to utilize a separate measurement device, such as a direct arterial line, to obtain reference pre-calibrated blood pressure measurements as taught by Clark as this facilitates the reduction in error of a generated compliance model, which may then be utilized in a continuous, non-invasive manner.
Yet their combined efforts fail to teach
The pre-calibrated blood pressure measurement device is placed on the user to obtain readings;
the plurality of calibration conditions corresponding to a respective placement of the portable housing.
However Asada teaches a calibration mode ([0063]-[0070]) such that:
in the calibration mode, the control processor is to perform a calibration routine to generate and store the calibration data