DETAILED ACTION
Claims 1-20 are pending and hereby under examination.
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 Objections
Claims 4 and 15 are objected to because of the following informalities:
Regarding claims 4 and 15, it should read “… between about 50 Hertz (Hz) …”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 and 12-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, it is unclear if the “audio transducers” in line 3 are the same, similar, or different the “an audio transducer” in line 2. Is only one or more than one audio transducer required to meet the claim? For examination purposes, the claim will be interpreted as only one audio transducer. Claims 2-10 are also rejected due to their dependence on claim 1.
Regarding claims 2 and 13, it is unclear how a determination that the health condition has changed is made. For a change to be determined, a predetermined or initial health condition is required to be known to determine that the condition has changed. For examination purposes, the claims will be interpreted such that a health condition is determined if there is a deviation of the average pressure from the threshold pressure range.
Regarding claims 3 and 14, the health condition is not positively recited in the body of claims 1 and 11; thus, the health condition type does not rely on any measurement.
When reading the preamble in the context of the entire claim, the recitation of “monitoring changes in a health condition” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
For examination purposes, claim 3 and 14 will be interpreted to depend on claim 2 and 13, respectively, wherein the determining a health condition step is recited. The term “proportionately spaced out” in claim 12 is a relative term which renders the claim indefinite. The term “proportionately spaced out” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how “spaced out” the audio transducers should be in order to meet the claim limitation. Should they have a specific distance between them, or would any amount of space between two audio transducers be sufficient? For examination purposes, the claim will be interpreted such that any space between two or more audio transducers is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kinast (US 20220330842 – cited by Applicant).
Regarding claim 1, Kinast teaches a method of monitoring for changes in a health condition using a non-invasive blood pressure measuring device comprising an audio transducer, the method comprising:
obtaining, from the audio transducers, an acoustic signal from a blood vessel (Paragraphs 0030-0031, non-invasively measuring blood pressure using acoustic sensors 104);
converting the acoustic signal to a pressure measurement, the pressure measurement corresponding to blood pressure within the blood vessel (Paragraph 0031, wherein inputs to the parameter calculator 110 include acoustic sensors 104, and parameter calculator 110 measures blood pressure);
sampling the pressure measurement over a sample frequency (Paragraph 0149-0150);
determining average pressure from the sampled pressure measurement over a target time period (Paragraph 0154, wherein blood pressure measurements may include mean blood pressure);
monitoring the average pressure for deviation from a threshold pressure range (Paragraph 0160, blood pressure exceeding a threshold blood pressure change value); and
generating an alert signal from the blood pressure measuring device if a deviation from the threshold pressure range is detected (Paragraph 0160, when blood pressure exceeds the threshold, triggering a patient alarm).
Regarding claim 9, Kinast further teaches applying an electronic low-pass filter to remove high frequency pressure artifacts (Paragraph 0149, applying low-pass filter to remove high frequency noise).
Regarding claim 10, Kinast further teaches wherein the high frequency pressure artifacts comprise blood pressure fluctuations caused by respiration (Paragraph 0149, applying low-pass filter to remove high frequency noise). Examiner notes that Kinast teaches applying a low-pass filter to remove high=frequency noise to allow the low frequency heart and pulse acoustic signals detected by the acoustic sensors; thus, the high frequency blood pressure fluctuations caused by respiration would inherently be filtered out.
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.
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 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Kinast as applied to claim 1 above, and further in view of Weffers-Albu (US 20210338174).
Regarding claims 2-3, Kinast discloses that blood pressure can be effected by physiological factors but fails to explicitly disclose determining a type of health condition based on a deviation from the threshold pressure range.
However, Weffers-Albu teaches a system for assessing emergency risk of a patient wherein blood pressure is measured from audio sensors (Paragraphs 0119-0129) and a threshold range is set on the blood pressure measurements to determine a myocardial infarction risk based on the threshold (Paragraph 0061). Weffers-Albu discusses non-typical values of blood pressure increase the risk of myocardial infarction. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kinast to incorporate the teachings of measuring a deviation of blood pressure measurement of Weffers-Albu to determine a myocardial infarction risk.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kinast as applied to claim 1 above, and further in view of Rajagopal (US 20210076954 – cited by Applicant).
Regarding claim 4, Kinast discloses applying low-pass filters to allow the low frequency pulse acoustic signals to be detected by the acoustic sensors (Paragraph 0149) but fails to explicitly disclose wherein the sample frequency is between 50 and 200 Hz.
However, Rajagopal teaches a blood pressure measurement apparatus wherein electroacoustic transducers are configured to vary over a range of frequencies between 1 and 500 Hz (Paragraphs 0044-0045). As applicant appears to have placed no criticality on the claimed range and since it has been held that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kinast to incorporate the teachings of varying the frequency over a specific range as taught by Rajagopal to detect low frequency pulse acoustic signals.
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kinast as applied to claim 1 above, and further in view of Rajagopal, Kliot (US 20060100530 – cited by Applicant), and Misener (US 20230135562).
Regarding claims 5-8, Kinast discloses determining, with a logical circuit coupled to the audio transducer, detected characteristics of the blood vessel based on the obtained audio signals (Paragraphs 0118-0119);
identifying, with the logical circuit, pre-identified detected characteristics and a pre-identified blood pressure measurement corresponding to the blood vessel (Paragraph 0119, “comparing the waveforms to models and/or thresholds”; Paragraph 0156, “The blood pressure measurements and pulse wave transit time measurements can be stored in memory (at least temporarily)”); and
storing the pressure measurement and the pre-identified detected characteristics corresponding to the target blood vessel are stored in a database (Paragraph 0156, “The blood pressure measurements and pulse wave transit time measurements can be stored in memory (at least temporarily). In some embodiments, the memory can include a predetermined capacity of measurements and the oldest measurements can be replaced by new measurements when capacity has been reached. The stored measurements can be used to generate a calibration curve”).
With regards to the limitations of claims 5-8, Kinast fails to disclose identifying a target blood vessel, the type of target blood vessel, detecting a resonant frequency of the audio signals, determining the pressure measurement based on the detected characteristics of the resonant frequency, the type of detected characteristics of the blood vessel, and determining the pressure measurement by applying the characteristics and resonant frequency to a transformed formula.
However, Rajagopal teaches a blood pressure measurement apparatus wherein a resonant frequency is detected (Paragraph 0035, “ a resonant frequency at which the artery vibrates most strongly may be discovered/estimated”), wherein a detected characteristic comprises a radius (Paragraph 0037), and a pressure measurement is made based on a detected characteristics and the resonant frequency in a transformed formula (Equation 1). Rajagopal discusses this way of measurement is useful to determine an absolute blood pressure (Paragraph 0035). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kinast to incorporate the teachings of measuring resonant frequency and vessel characteristics to determine a pressure measurement of Rajagopal to determine an absolute blood pressure.
Kliot teaches a system for monitoring physiological parameters wherein a transducer array scans a tissue to identify a target vessel of interest (Paragraph 0046), which Kliot discusses is useful to detect blood flow anomalies and blood pressure (Paragraph 0046). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device Kinast and Rajagopal to incorporate the teachings of Kliot to identify a target vessel and detect blood pressure and blood flow anomalies.
Misener teaches an ultrasound system wherein logic may identify a blood vessel as a vein or an artery based on characteristics of the vessel (Paragraphs 0063-0064). One of ordinary skill in the art would have been motivated to apply this known technique of identifying a blood vessel of Misener to the known device of Kinast as modified that was ready for improvement and the results of identifying a vein or an artery would have been predictable to one of ordinary skill in the art. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kinast, Rajagopal, and Kliot to incorporate the teachings of Misener to identify a vein or an artery.
Claims 11-12, 15-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kinast and Rajagopal.
Regarding claims 11, Kinast discloses a system for non-invasively monitoring a health condition based on measured blood pressure, the system comprising:
a plurality of audio transducers configured to capture tomographical information of a physiological structure (Fig. 7, acoustic sensors 702A-C);
an audio coupling medium on each of the plurality of audio transducer (Paragraph 0086, wherein the acoustic sensors are coupled to an acoustic module); and
one or more processors (Fig. 1, parameter calculator 110) configured to:
cause one of the plurality of audio transducers to obtain audio signals reflected by a blood vessel (Paragraphs 0030-0031, non-invasively measuring blood pressure using acoustic sensors 104);
sample the pressure measurement over a sample frequency (Paragraph 0149-0150);
determine an average pressure from the sampled pressure measurement over a target time period (Paragraph 0154, wherein blood pressure measurements may include mean blood pressure);
monitor the average pressure for deviation from a threshold pressure range (Paragraph 0160, blood pressure exceeding a threshold blood pressure change value); and
generate an alert signal from the blood pressure measuring device if a deviation from the threshold pressure range is detected (Paragraph 0160, when blood pressure exceeds the threshold, triggering a patient alarm).
Kinast fails to disclose determining a detected characteristic of the blood vessel, detecting a resonant frequency of the audio signals reflected by the blood vessel, and determining a pressure measurement of the blood vessel based on the detected characteristics and the resonant frequency.
However, Rajagopal teaches a blood pressure measurement apparatus wherein a resonant frequency is detected (Paragraph 0035, “ a resonant frequency at which the artery vibrates most strongly may be discovered/estimated”), wherein a detected characteristic comprises a radius (Paragraph 0037), and a pressure measurement is made based on a detected characteristics and the resonant frequency (Equation 1). Rajagopal discusses this way of measurement is useful to determine an absolute blood pressure (Paragraph 0035). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kinast to incorporate the teachings of measuring resonant frequency and vessel characteristics to determine a pressure measurement of Rajagopal to determine an absolute blood pressure.
Regarding claim 12, Kinast as modified further discloses wherein the plurality of audio transducers are proportionately spaced out to maximize detection of blood vessels (Fig. 7, acoustic sensors 702A-C).
Regarding claim 15, Kinast as modified discloses applying low-pass filters to allow the low frequency pulse acoustic signals to be detected by the acoustic sensors (Paragraph 0149) but fails to explicitly disclose wherein the sample frequency is between 50 and 200 Hz.
However, Rajagopal teaches a blood pressure measurement apparatus wherein electroacoustic transducers are configured to vary over a range of frequencies between 1 and 500 Hz (Paragraphs 0044-0045). As applicant appears to have placed no criticality on the claimed range and since it has been held that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kinast and Rajagopal to incorporate the teachings of varying the frequency over a specific range as taught by Rajagopal to detect low frequency pulse acoustic signals.
Regarding claim 16, Kinast as modified further discloses wherein the pressure measurement and detected characteristics corresponding to the blood vessel are stored in a database.
Regarding claim 18, Kinast as modified further discloses applying an electronic low-pass filter to remove high frequency pressure artifacts (Paragraph 0149, applying low-pass filter to remove high frequency noise).
Regarding claim 19, Kinast as modified further discloses wherein the high frequency pressure artifacts comprise blood pressure fluctuations caused by respiration (Paragraph 0149, applying low-pass filter to remove high frequency noise). Examiner notes that Kinast discloses applying a low-pass filter to remove high-frequency noise to allow the low frequency heart and pulse acoustic signals detected by the acoustic sensors; thus, the high frequency blood pressure fluctuations caused by respiration would inherently be filtered out.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kinast and Rajagopal as applied to claim 11 above, and further in view of Weffers-Albu.
Regarding claims 13-14, Kinast as modified discloses that blood pressure can be effected by physiological factors but fails to explicitly disclose determining a type of health condition based on a deviation from the threshold pressure range.
However, Weffers-Albu teaches a system for assessing emergency risk of a patient wherein blood pressure is measured from audio sensors (Paragraphs 0119-0129) and a threshold range is set on the blood pressure measurements to determine a myocardial infarction risk based on the threshold (Paragraph 0061). Weffers-Albu discusses non-typical values of blood pressure increase the risk of myocardial infarction. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kinast and Rajagopal to incorporate the teachings of measuring a deviation of blood pressure measurement of Weffers-Albu to determine a myocardial infarction risk.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kinast and Rajagopal as applied to claim 11 above, and further in view of Misener.
Regarding claim 17, Kinast as modified discloses the system as described above. Kinast as modified fails to disclose wherein the characteristic is identifying the type of blood vessel.
However, Misener teaches an ultrasound system wherein logic may identify a blood vessel as a vein or an artery based on characteristics of the vessel (Paragraphs 0063-0064). One of ordinary skill in the art would have been motivated to apply this known technique of identifying a blood vessel of Misener to the known device of Kinast as modified that was ready for improvement and the results of identifying a vein or an artery would have been predictable to one of ordinary skill in the art. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kinast and Rajagopal to incorporate the teachings of Misener to identify a vein or an artery.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kinast, Rajagopal, and Kliot.
Regarding claims 20, Kinast discloses a system for non-invasively monitoring changes in a health condition based on measured blood pressure, the system comprising:
a plurality of audio transducers configured to capture tomographical information of a physiological structure (Fig. 7, acoustic sensors 702A-C);
an audio coupling medium on each of the plurality of audio transducer (Paragraph 0086, wherein the acoustic sensors are coupled to an acoustic module); and
a processing device (Fig. 1, parameter calculator 110) configured to:
transmit, from one of the plurality of audio transducers, audio energy directed towards a blood vessel;
obtain, with one of the plurality of audio transducers, audio signals reflected by a blood vessel (Paragraphs 0030-0031, non-invasively measuring blood pressure using acoustic sensors 104);
identify a pre-identified pressure measurement corresponding to the blood vessel (Paragraph 0156, “The blood pressure measurements and pulse wave transit time measurements can be stored in memory (at least temporarily). In some embodiments, the memory can include a predetermined capacity of measurements and the oldest measurements can be replaced by new measurements when capacity has been reached. The stored measurements can be used to generate a calibration curve”)
determine a variation in blood pressure of the blood vessel based on the pre-identified blood pressure measurement, and the blood pressure measurement (Paragraph 0156, “The blood pressure measurements and pulse wave transit time measurements can be stored in memory (at least temporarily). In some embodiments, the memory can include a predetermined capacity of measurements and the oldest measurements can be replaced by new measurements when capacity has been reached. The stored measurements can be used to generate a calibration curve”; Paragraph 0058, determining blood pressure non-invasively; Examiner notes that Kinast discloses measuring a variation of heart rate (Paragraph 0145), and it is within the skill of one of ordinary skill in the art to able to measure a variation of a blood pressure measurement); and
display the blood pressure measurement and the variation in blood pressure on a graphical user interface (Fig. 1, display 120).
Kinast fails to disclose determining a detected characteristic of the blood vessel, identifying the blood vessel as a target blood vessel, detecting a resonant frequency of the audio signals reflected by the blood vessel, and determining a pressure measurement of the blood vessel based on the detected characteristics and the resonant frequency.
However, Rajagopal teaches a blood pressure measurement apparatus wherein a resonant frequency is detected (Paragraph 0035, “a resonant frequency at which the artery vibrates most strongly may be discovered/estimated”), wherein a detected characteristic comprises a radius (Paragraph 0037), and a pressure measurement is made based on a detected characteristics and the resonant frequency (Equation 1). Rajagopal discusses this way of measurement is useful to determine an absolute blood pressure (Paragraph 0035). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kinast to incorporate the teachings of measuring resonant frequency and vessel characteristics to determine a pressure measurement of Rajagopal to determine an absolute blood pressure.
Kliot teaches a system for monitoring physiological parameters wherein a transducer array scans a tissue to identify a target vessel of interest (Paragraph 0046), which Kliot discusses is useful to detect blood flow anomalies and blood pressure (Paragraph 0046). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device Kinast and Rajagopal to incorporate the teachings of Kliot to identify a target vessel and detect blood pressure and blood flow anomalies.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791