DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/22/2025 has been entered.
Response to Amendment
This action is in response to the remarks filed on 10/22/2025.
The amendments filed on 10/22/2025 have been entered. Accordingly claims 1-18 and 25-26 remain pending. Claims 19-24 were previously cancelled.
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 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims 1 and 13 recite “analyzing the imaging signal”
The limitation of “analyzing”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic components. That is, nothing in the claim element precludes the step from practically being performed in the mind. For example, “analyzing” in the context of this claim encompasses the user manually analyzing/calculating the signals. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claims recite additional element – photoacoustic imaging band/patch- to perform the limitation of “contacting the photoacoustic imaging”, “delivering energy” and “receiving a detectable imaging signal”. The photoacoustic imaging in both steps is recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element to perform the above noted steps amount to no more than mere instructions to apply the exception using a generic component. Mere instructions to apply an exception using a generic component cannot provide an inventive concept.
The claim is not patent eligible.
Similarly, the depending claims abstract idea without significantly more (e.g., estimating stroke volumes…, etc.), under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic components.
The depending claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element to perform the above noted steps amount to no more than mere instructions to apply the exception using a generic component. Mere instructions to apply an exception using a generic component cannot provide an inventive concept.
The claim is not patent eligible.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 7, 10-12, 17-18 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Su et al (US 20130184544 A1) in view of KITCHENS et al (US20220175258) and Stein et al (US20140194740A1).
Referring to claim 1 (as the claim best understood in light of the 35 USC 112 rejections above), Su teaches a method of automatically measuring blood pressure (para [0003], (0031]- For example, sensor unit 12, monitor14, or both, maybe configured to determine pulse rate, blood pressure, blood oxygen saturation (e.g., arterial, venous, or both), hemoglobin concentration (e.g., oxygenated, deoxygenated, or total), any other suitable physiological parameters, or any combination thereof), comprising:
applying a photoacoustic imaging band comprising a photoacoustic imaging transducer to an extremity of a patient (“a photoacoustic monitor or imaging system… include a light source 16 for emitting light …detector 18 …provided in sensor unit 12 for detecting the acoustic (e.g., ultrasound)” [0028]; “processing circuitry 42 may be configured to operate light source 16 and detector 18 to generate and process photoacoustic signals” [0031]; “detector 18 may be a piezoelectric transducer which may detect force and pressure” [0041]; para [0017}-A photoacoustic system may include a photoacoustic sensor that is placed at a site on a subject, typically a wrist, palm, elbow, neck, forehead, temple, inner ear, thigh, or other location where blood vessels are within the sensitivity range of the instrument; para [0065));
contacting the photoacoustic imaging band to allocation on the extremity adjacent to allocation of a vessel of interest (para [0017]-A photoacoustic system may include a photoacoustic sensor that is placed at a site on a subject, typically a wrist, palm, elbow, neck, forehead, temple, inner ear, thigh, or other location where blood vessels are within the sensitivity range of the instrument; para[0064]-[0065));
delivering “acoustic” energy to the extremity with the photoacoustic imaging transducer at the location of the vessel of interest (para [0017]-The photoacoustic system may use a light source, and any suitable light guides (e.g., fiberoptics), to pass light through the subject's tissue, or a combination of tissue thereof (e.g., organs), and an acoustic detector to sense the pressure response of the tissue. Tissue may include muscle, fat, blood, blood vessels; para [0064]-[0065));
receiving imaging information generated in response to the delivered energy (“The enhanced spatial resolution of the photoacoustic technique may allow for imaging, scalar field mapping, and other spatially resolved results, in 1, 2, or 3 spatial dimensions. The acoustic response to the photonic excitation may radiate from the illuminated target area, and accordingly may be detected at multiple positions” [0017]); and computing the acoustic energy (“PA signals from multiple spatial locations may be used to construct an image (e.g., imaging blood vessels) or a scalar field (e.g., a hemoglobin concentration field)” [0018]);
generating a detectable image of the vessel of interest from the imaging information received from the photoacoustic imaging transducer using a central processing unit where the detectable image represents the vessel of interest (“The enhanced spatial resolution of the photoacoustic technique may allow for imaging, scalar field mapping, and other spatially resolved results, in 1, 2, or 3 spatial dimensions. The acoustic response to the photonic excitation may radiate from the illuminated target area, and accordingly may be detected at multiple positions” [0018]; “processing circuitry 42 may be configured to operate light source 16 and detector 18 to generate and process photoacoustic signals” [0031]; “detector 18 may be a piezoelectric transducer which may detect force and pressure” [0041]; para [0019]-PA signals from multiple spatial locations may be used to construct an image (e.g., imaging blood vessels)); and
analyzing the detectable image and the delivered energy to determine blood flow and blood pressure by using the central processing unit to execute a software application (para [0016]-for example, tissue of the subject, may be used for medical imaging, physiological parameter determination, or both. For example, the concentration of a constituent such as hemoglobin, both oxygenated and deoxygenated, blood pressure, pulse rate, and blood flow may be determined using photoacoustic analysis; para [0028], [0042], [0044]).
As can be clearly and factually seen above, Su teaches all the claimed limitations. Yet, in any case or in any interpretation, if one argues that the Su does not teach analytical steps as claimed (i.e., photoacoustic imaging transducer; and analyzing the detectable image and the delivered energy to determine blood flow and blood pressure by using the central processing unit to execute a software application) which the office does not concede, Kitchens reference is brought in to also show that these steps are further taught in an effort to provide compact prosecution.
In the same field of endeavor, Kitchens teaches methods involve controlling, via a control system, a light source system to emit a plurality of light pulses into biological tissue including blood and blood vessels at depths and receiving, by the control system, signals from the piezoelectric receiver corresponding to acoustic waves emitted from portions of the biological tissue, the acoustic waves corresponding to photoacoustic emissions from the blood and the blood vessels caused by the plurality of light pulses. Such methods may involve detecting, by the control system, heart rate waveforms in the signals, determining, by the control system, a first subset of detected heart rate waveforms corresponding to vein heart rate waveforms and determining, by the control system, a second subset of detected heart rate waveforms corresponding to artery heart rate waveforms (abst). The acoustic waves may correspond to photoacoustic emissions from the blood and the blood vessels caused by the plurality of light pulses. Block 905 may involve detecting heart rate waveforms in the signals [0111]. Block 1039 involves HRW generation according to a Hilbert transform of detected acoustic waves corresponding to photoacoustic emissions from the blood and the blood vessels. The Hilbert transform returns a complex helical sequence, sometimes called the analytic signal, from a real data sequence [0122].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with analyzing the detectable image and the delivered energy to determine blood flow and blood pressure by using the central processing unit to execute a software application as taught by Kitchens because it provides an accurate estimation or “picture” of blood pressure, and a user's health in general, over time ([0003] of Kitchens).
Further, although, under the BRI, the claim does not necessarily require the “additional” or second “acoustic energy” via separate ultrasound transducer (i.e., doppler as noted in the specification), Stein reference is introduced in an effort to provide compact prosecution to show that the narrow interpretation is also taught.
However, in the same field of endeavor, Stein teaches device, method, and system for detecting emboli in the brain is disclosed. A transcranial Doppler photoacoustic device transmits a first energy to a region of interest at an internal site of a subject to produce an image and blood flow velocities of a region of interest by outputting an optical excitation energy to said region of interest and heating said region, causing a transient thermoelastic expansion and produce a wideband ultrasonic emission. Detectors receive the wideband ultrasonic emission and then generate an image of said region of interest from said wideband ultrasonic emission. A Doppler ultrasound signal will also be deployed to image the region of interest. Doppler presents changes in velocity to map blood flow. Additionally, a dye can be given to visualize the brain vasculature and a perfusion measurement can be made in various regions of the brain along with the transcranial Doppler and the photoacoustic screening (abst).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with additional” or second “acoustic energy” delivery via separate ultrasound transducer as taught by Stein because this helps to improve care quality, patient safety, and reduce costs ([0041] of Stein).
Referring to claim 2, SU teaches the method of automatically measuring blood pressure of claim 1. SU further teaches wherein the location on the extremity is overlying a presumed location of a brachial artery (para [0003], [0017], [0064]-A support assembly of the body mounted sensor could also encircle an... arm... any other suitable location, or any suitable combination of locations).
Referring to claim 3, SU teaches the method of automatically measuring blood pressure of claim 1. SU further teaches wherein the location on the extremity is overlying a presumed location of a radial artery (para [0076]- FIG. 8 is an axial view of a wrist-mounted photoacoustic sensor unit showing the detector in proximity to the radial artery in accordance with some embodiments of the present disclosure).
Referring to claim 4, SU teaches the method of automatically measuring blood pressure of claim 1. SU further teaches wherein the location on the extremity is overlying a presumed location of a carotid artery (para[0064]- A support assembly of the body mounted sensor could also encircle...neck, any other suitable location, or any suitable combination of locations).
Referring to claim 5, SU teaches the method of automatically measuring blood pressure of claim 1. SU further teaches wherein the location on the extremity is overlying a presumed location of a cerebral artery (para [0017]-A photoacoustic system may include a photoacoustic sensor that is place data site on a subject, typically a wrist, palm, elbow, neck, forehead, temple, inner ear, thigh, or other location where blood vessels are within the sensitivity range of the instrument; para [0064)).
Referring to claim 7, SU teaches the method of automatically measuring blood pressure of claim 1. SU further teaches measuring a pulsatile flow with a sphygmometer cuff (para[0036]-Such calibration devices may include, for example, an aneroid or mercury sphygmomanometer and occluding cuff).
Referring to claim 10, SU teaches the method of automatically measuring blood pressure of claim 1. SU further teaches transmitting blood pressure information to an external device (para [0075]-A high pressure level may be indicative of a pressure that may impede, reduce, or otherwise alter blood flow and other physiological processes within or near the target area. Data from a pressure sensor maybe displayed on a display, e.g., display 612 of FIG. 6, or transmitted to an external monitor, e.g., monitor 14 of FIG.1).
Referring to claim 11, SU teaches the method of automatically measuring blood pressure of claim 1. SU further teaches measuring blood flow, pulseoximetry, hemoglobin, changes in blood pressure size, or a combination thereof (note: blood pressure, blood flow, hemoglobin is disclosed) (para[0016]-For example, the concentration of a constituent such as hemoglobin, both oxygenated and deoxygenated, blood pressure, pulse rate, and blood flow maybe determined using photoacoustic analysis, para[0083]- This display maybe configured to display pulse rate, blood pressure, blood oxygen saturation (e.g., arterial, venous, or both), hemoglobin concentration (e.g., oxygenated, deoxygenated, or total)).
Referring to claim 12, SU teaches the method of automatically measuring blood pressure of claim 1. SU further teaches estimating stroke volumes, cardiac output, systemic vascular resistance, pulse pressure variation, systolic pressure variation, or a combination thereof using waveform analysis (para [0040]- [0041], [0063]-When measuring the blood pressure in an artery, the distance between the two peaks will vary over the cardiac cycle and the different distances may correspond to different pressures).
Referring to claim 17, SU teaches an automated blood pressure monitoring device (para[0003],[0031]-For example, sensor unit 12, monitor 14, or both, maybe configured to determine pulse rate, blood pressure, blood oxygen saturation (e.g., arterial, venous, or both), hemoglobin concentration (e.g., oxygenated, deoxygenated, or total), any other suitable physiological parameters, or any combination thereof), comprising:
a photoacoustic element coupled to a band comprising a photoacoustic imaging transducer (“a photoacoustic monitor or imaging system… include a light source 16 for emitting light …detector 18 …provided in sensor unit 12 for detecting the acoustic (e.g., ultrasound)” [0028]; “processing circuitry 42 may be configured to operate light source 16 and detector 18 to generate and process photoacoustic signals” [0031]; “detector 18 may be a piezoelectric transducer which may detect force and pressure” [0041]; para [0065]- In the embodiment shown in FIG. 6, the support assembly 610 is a strap, band, or bracelet that will support the parts comprising a photoacoustic system such as sensor unit12); and
an ultrasound transducer coupled to and disposed in a position in adjacent to the photoacoustic element (para [0017]-The photoacoustic system may use a light source, and any suitable light guides (e.g., fiberoptics), to pass light through the subject's tissue, or a combination of tissue thereof (e.g., organs), and an acoustic detector to sense the pressure response of the tissue... the acoustic detector maybe an ultrasound detector).
As can be clearly and factually seen above, Su teaches all the claimed limitations. Yet, in any case or in any interpretation, if one argues that the Su does not teach analytical steps as claimed (i.e., photoacoustic imaging transducer) which the office does not concede, Kitchens reference is brought in to also show that these steps are further taught in an effort to provide compact prosecution.
In the same field of endeavor, Kitchens teaches methods involve controlling, via a control system, a light source system to emit a plurality of light pulses into biological tissue including blood and blood vessels at depths and receiving, by the control system, signals from the piezoelectric receiver corresponding to acoustic waves emitted from portions of the biological tissue, the acoustic waves corresponding to photoacoustic emissions from the blood and the blood vessels caused by the plurality of light pulses. Such methods may involve detecting, by the control system, heart rate waveforms in the signals, determining, by the control system, a first subset of detected heart rate waveforms corresponding to vein heart rate waveforms and determining, by the control system, a second subset of detected heart rate waveforms corresponding to artery heart rate waveforms (abst). The acoustic waves may correspond to photoacoustic emissions from the blood and the blood vessels caused by the plurality of light pulses. Block 905 may involve detecting heart rate waveforms in the signals [0111]. Block 1039 involves HRW generation according to a Hilbert transform of detected acoustic waves corresponding to photoacoustic emissions from the blood and the blood vessels. The Hilbert transform returns a complex helical sequence, sometimes called the analytic signal, from a real data sequence [0122].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with photoacoustic imaging transducer as taught by Kitchens because it provides an accurate estimation or “picture” of blood pressure, and a user's health in general, over time ([0003] of Kitchens).
Further, although, under the BRI, the claim does not necessarily require the “additional” or second “acoustic energy” via separate ultrasound transducer (i.e., doppler as noted in the specification), Stein reference is introduced in an effort to provide compact prosecution to show that the narrow interpretation is also taught.
However, in the same field of endeavor, Stein teaches device, method, and system for detecting emboli in the brain is disclosed. A transcranial Doppler photoacoustic device transmits a first energy to a region of interest at an internal site of a subject to produce an image and blood flow velocities of a region of interest by outputting an optical excitation energy to said region of interest and heating said region, causing a transient thermoelastic expansion and produce a wideband ultrasonic emission. Detectors receive the wideband ultrasonic emission and then generate an image of said region of interest from said wideband ultrasonic emission. A Doppler ultrasound signal will also be deployed to image the region of interest. Doppler presents changes in velocity to map blood flow. Additionally, a dye can be given to visualize the brain vasculature and a perfusion measurement can be made in various regions of the brain along with the transcranial Doppler and the photoacoustic screening (abst). Pre-processing of TCD data, aligning the TCD data to an absolute reference frame, and also relaying real-time images of the Doppler signal, synchronized with the pulse and the estimated depth and position of the insonated vasculature [0088].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with additional” or second “acoustic energy” delivery via separate ultrasound transducer as taught by Stein because this helps to improve care quality, patient safety, and reduce costs ([0041] of Stein).
Referring to claim 18, SU teaches the automated blood pressure monitoring device of claim 17. SU further teaches a pressure cuff coupled to and adjacent to the photoacoustic element (para [0036]- it will be understood that calibration device 80 could operate in any suitable manner, e.g., by attachment to sensor unit 12... Such calibration devices may include, for example, an aneroid or mercury sphygmomanometer and occluding cuff; para[0028]-sensor unit 12 maybe part of a photoacoustic monitor or imaging system).
Referring to claim 25, SU teaches a sphygmometer having a pressure cuff (para [0036]-Such calibration devices may include, for example, an aneroid or mercury sphygmomanometer and occluding cuff) adjacent to the photoacoustic element (para[0017]-The photoacoustic system may use a light source, and any suitable light guides (e.g., fiberoptics), to pass light through the subject's tissue, or a combination of tissue thereof (e.g., organs), and an acoustic detector to sense the pressure response of the tissue...the acoustic detector maybe an ultrasound detector; para[0036],[0065)).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Su in view of Kitchens and Stein further in view of Rice et al (US 20210022623).
Referring to claim 6, the above noted combination teaches all the claimed limitations except for non-pulsatile flow with a sphygmometer cuff.
However, in the same field of endeavor, Rice teaches non-invasive hemodynamic assessment (title), teaches measuring a non-pulsatile flow with a cuff (para [0047]-. For example, a non-pulsatile amplitude may characterize the flow amplitude after purposefully obstructing the pulse through arterial occlusion e.g., via an inflatable arm cuff)).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with measuring a non-pulsatile flow with a cuff as taught by Rice because it would improve patient healthcare (RICE, para [0003]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Su in view of Kitchens and Stein further in view of Hoctor et al (US20050143640)
Referring to claim 8, the above noted combination teaches all the claimed limitations except for pulse wave velocity signal.
However, in the same field of endeavor, Hoctor teaches blood pressure monitoring (abstract), teaches receiving a pulse wave velocity signal (para[0036]-The use of transcutaneous ultrasound can provide volumetric flow, arterial lumen area and pulse wave velocity information).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with pulse wave velocity signal as taught by Hoctor because the PWV has the potential to provide diagnostic information about the state of the arterial segment being investigated and may also be indicative of overall arterial health (HOCTOR, para [0008]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Su in view of Kitchens and Stein further in view of McKenna (US 20110071598).
Referring to claim 9, the above noted combination teaches all the claimed limitations except for continuous wave signal.
However, in the same field of endeavor, MCKENNA teaches photoacoustic spectroscopy (abstract). Receiving a continuous wave signal (para[0026]-While microcirculation data may be determined from signal from the photoacoustic spectroscopy sensor 12 alone, in certain embodiments, data relating to one or more additional patient parameters may obtained at step 68 to augment the data from the continuous wave photoacoustic spectroscopy sensor12).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with continuous wave signal as taught by because improve patient health (MCKENNA, para [0026]).
Claims 13-16 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Su in view of Kitchens and further in view of Nanyang (US 20180064346).
Referring to claims 13 and 26, Su teaches a method of automatically measuring blood pressure (para [0003], [0031]- For example, sensor unit 12, monitor14, or both, maybe configured to determine pulse rate, blood pressure, blood oxygen saturation (e.g., arterial, venous, or both), hemoglobin concentration (e.g., oxygenated, deoxygenated, or total), any other suitable physiological parameters, or any combination thereof), comprising:
applying a photoacoustic imaging comprising a photoacoustic imaging transducer to an extremity of a patient (“detector 18 may be a piezoelectric transducer which may detect force and pressure” [0041]; para [0017}-A photoacoustic system may include a photoacoustic sensor that is placed at a site on a subject, typically a wrist, palm, elbow, neck, forehead, temple, inner ear, thigh, or other location where blood vessels are within the sensitivity range of the instrument; para [0065));
contacting the photoacoustic imaging band to allocation on the extremity adjacent to allocation of a vessel of interest (para [0017]-A photoacoustic system may include a photoacoustic sensor that is placed at a site on a subject, typically a wrist, palm, elbow, neck, forehead, temple, inner ear, thigh, or other location where blood vessels are within the sensitivity range of the instrument; para[0064]-[0065));
delivering energy to the extremity with the photoacoustic imaging band at the location of the vessel of interest (para [0017]-The photoacoustic system may use a light source, and any suitable light guides (e.g., fiberoptics), to pass light through the subject's tissue, or a combination of tissue thereof (e.g., organs), and an acoustic detector to sense the pressure response of the tissue. Tissue may include muscle, fat, blood, blood vessels; para [0064]-[0065));
receiving imaging information generated in response to the delivered energy (“The enhanced spatial resolution of the photoacoustic technique may allow for imaging, scalar field mapping, and other spatially resolved results, in 1, 2, or 3 spatial dimensions. The acoustic response to the photonic excitation may radiate from the illuminated target area, and accordingly may be detected at multiple positions” [0017]); and computing the acoustic energy (“PA signals from multiple spatial locations may be used to construct an image (e.g., imaging blood vessels) or a scalar field (e.g., a hemoglobin concentration field)” [0018]);
generating a detectable image of the vessel of interest from the imaging information received from the photoacoustic imaging transducer using a central processing unit where the detectable image represents the vessel of interest (“The enhanced spatial resolution of the photoacoustic technique may allow for imaging, scalar field mapping, and other spatially resolved results, in 1, 2, or 3 spatial dimensions. The acoustic response to the photonic excitation may radiate from the illuminated target area, and accordingly may be detected at multiple positions” [0018]; “processing circuitry 42 may be configured to operate light source 16 and detector 18 to generate and process photoacoustic signals” [0031]; “detector 18 may be a piezoelectric transducer which may detect force and pressure” [0041]; para [0019]-PA signals from multiple spatial locations may be used to construct an image (e.g., imaging blood vessels)); and
analyzing the detectable image and the delivered energy to determine blood flow and blood pressure by using the central processing unit to execute a software application (para [0016]-for example, tissue of the subject, may be used for medical imaging, physiological parameter determination, or both. For example, the concentration of a constituent such as hemoglobin, both oxygenated and deoxygenated, blood pressure, pulse rate, and blood flow may be determined using photoacoustic analysis; para [0028], [0042], [0044]).
Su does not teach patch.
However, in the same field of endeavor, NANYANG teaches photoacoustic sensors (abstract), wherein the photoacoustic imaging device is a patch (para[0103]-FIG.5 illustrates an exemplary architecture for a sensor processing module for deriving blood core temperature… photo-acoustic sensor 104 comprises a patch sensor implementing a CMUT ultrasound transducer array to receive the PA signal).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with a patch as taught by NANYANG because improves sensing resolution (NANYANG, para [0041]).
Further, although, under the BRI, the claim does not necessarily require the “additional” or second “acoustic energy” via separate ultrasound transducer (i.e., doppler as noted in the specification), Stein reference is introduced in an effort to provide compact prosecution to show that the narrow interpretation is also taught.
However, in the same field of endeavor, Stein teaches device, method, and system for detecting emboli in the brain is disclosed. A transcranial Doppler photoacoustic device transmits a first energy to a region of interest at an internal site of a subject to produce an image and blood flow velocities of a region of interest by outputting an optical excitation energy to said region of interest and heating said region, causing a transient thermoelastic expansion and produce a wideband ultrasonic emission. Detectors receive the wideband ultrasonic emission and then generate an image of said region of interest from said wideband ultrasonic emission. A Doppler ultrasound signal will also be deployed to image the region of interest. Doppler presents changes in velocity to map blood flow. Additionally, a dye can be given to visualize the brain vasculature and a perfusion measurement can be made in various regions of the brain along with the transcranial Doppler and the photoacoustic screening (abst).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with additional” or second “acoustic energy” delivery via separate ultrasound transducer as taught by Stein because this helps to improve care quality, patient safety, and reduce costs ([0041] of Stein).
Referring to claim 14, the combination noted above teaches all the claimed limitations except for patch with the use of a temporary adhesive.
However, in the same field of endeavor, NANYANG teaches photoacoustic sensors (abstract), wherein the photoacoustic imaging device is a patch (para[0103]-FIG.5 illustrates an exemplary architecture for a sensor processing module for deriving blood core temperature… photo-acoustic sensor 104 comprises a patch sensor implementing a CMUT ultrasound transducer array to receive the PA signal).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with a patch as taught by NANYANG because improves sensing resolution (NANYANG, para [0041]).
Referring to claim 15, the combination noted above teaches the method of automatically measuring blood pressure of claim 13. SU further teaches measuring blood flow, pulseoximetry, hemoglobin, changes in blood pressure size, or a combination thereof (note: blood pressure, blood flow, hemoglobin is disclosed) (para[0016]-For example, the concentration of a constituent such as hemoglobin, both oxygenated and deoxygenated, blood pressure, pulse rate, and blood flow maybe determined using photoacoustic analysis, para[0083]- This display maybe configured to display pulse rate, blood pressure, blood oxygen saturation (e.g., arterial, venous, or both), hemoglobin concentration (e.g., oxygenated, deoxygenated, or total)).
Referring to claim 16, the combination noted above teaches the method of automatically measuring blood pressure of claim 13. SU further teaches estimating stroke volumes, cardiac output, systemic vascular resistance, pulse pressure variation, systolic pressure variation, or a combination thereof using waveform analysis (para [0040]- [0041], [0063]-When measuring the blood pressure in an artery, the distance between the two peaks will vary over the cardiac cycle and the different distances may correspond to different pressures).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive at least for the reasons noted below;
Regarding the rejection of claims under 35 USC 101, the applicant argues the following;
The claimed methods integrate photoacoustic imaging-a hybrid optical-acoustic process-into a sequence of physical steps: delivering optical energy into a biological tissue, or blood vessel, detecting acoustic signals generated by the imaging information, computing acoustic energy and forming an image, using a central processing unit, and determining blood flow and blood pressure from that image.
These operations cannot be performed mentally or abstractly; they require specialized hardware (photoacoustic imaging band, transducer, and central processing unit).
The claims are therefore not directed to an abstract idea, but a specific application of physics to measure physiological parameters.
Even if the "analyzing" or "computing" aspects involve data processing, those operations occur within a specialized system performing a concrete medical function. The claim therefore is not "directed to" an abstract idea under Alice Step 2A, Prong 1.
While the Office asserts that "analyzing" or computing acoustic energy constitutes data processing or even steps that could be performed in the mind, the claim integrates these alleged abstract ideas into a practical application.
The methods, as claimed, use a particular machine, the photoacoustic imaging band comprising a photoacoustic transducer and central processing unit. The methods also produce a tangible image representing a vessel of interest and rely on energy interaction with a vessel of interest to obtain physiological data, thereby achieving a technological improvement in blood pressure measurement compared to conventional techniques.
Contrary to the applicant’s assertion, claims still recite abstract idea as "generating" and "analyzing" which are processes that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. Other than the recitation of generic computer components (“central processing unit”) nothing in the claim element precludes the step from practically being performed in the mind.
Further, the applicant also argues that the structural components (i.e., "analyzing" or "computing" aspects involve data processing, those operations occur within a specialized system performing a concrete medical function) which are all generic component that is used for mere data gathering which are examples of activities that courts have found to be insignificant extra-solution activity. These components are widely practiced and commonly known with no specificity which courts have found to be insignificant extra-solution activity.
It is further noted that the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception even with the newly amended limitations which merely adds generic “detectable image” with CPU which is NOT a specific technological environment and DOES NOT provide a technological improvement over conventional data analysis due to their generic and broad nature.
Therefore, under its broadest reasonable interpretation, claims cover performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Judicial exception is not integrated into a practical application since the claim only recites additional element generic computer components (“central processing unit”).
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The claims are not patent eligible.
Regarding the rejection of claims under 35 USC 103, applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/SERKAN AKAR/ Primary Examiner, Art Unit 3797