DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant’s amendments filed 12/10/2025 have been entered. Currently claims 1-48, 50-131 and 136-139 are pending with claims 83-131 withdrawn.
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.
Claims 64, 73, 74, 77, 78 and 139 are rejected under 35 U.S.C. 103 as being unpatentable over Mourad et al., (US20070016031A1) in view of Southard et al., (US20200237403A1) and Zhang et al., “Estimation of complex arterial elastic modulus from ring resonance excited by ultrasound radiation force” Ultrasonics, Volume 44, Supplement, 2006, Pages e169-e172
Regarding claim 64, A blood pressure measurement apparatus comprising: at least a first transducer to direct a first set of soundwaves and a second set of soundwaves to a blood vessel ([0112] a transducer may provide the interrogation signals, and may operate at different frequencies to induce tissue displacement (vibrate) and can send a second set of signals; [0073] the tissue is on/within the blood vessel, therefore the blood vessel would also vibrate),
and a second transducer to:
ultrasonic waves to the blood vessel ([0112] multiple acoustic transducer may be used to transmit signals);
determine the vibrational response of the blood vessel to the first set of soundwaves and a vibrational response of the blood vessel to the second set of soundwaves based on the ultrasonic waves being reflected by the blood vessel ([0112] the signals induce tissue displacement/oscillation; fig. 8 detection element 56 detects the tissue displacement).
However, Mourad is silent regarding the second set of sound waves having a frequency that is adjusted based on a vibrational response of the blood vessel to the first set of sound waves.
In the same acoustic imaging field of endeavor, Southard teaches the second set of sound waves having a frequency that is adjusted based on a vibrational response of the blood vessel to the first set of sound waves ([0110] the system detects the ultrasound signals echoed off the blood vessel and received by the probe, and adjusted the operating frequency of the probe to optimize the acquired ultrasound image).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the apparatus of Mourad with the adjusting frequency process of Southard, as this would allow for the optimization of the ultrasound image (See Southard [0023]).
However, the combination of references are still silent regarding determining a resonant frequency of the blood vessel based on the vibrational response of the blood vessel to the second set of soundwaves.
In the same ultrasound field of endeavor, Zhang teaches determining a resonant frequency of the blood vessel based on the vibrational response of the blood vessel to the second set of soundwaves (page e170 Results and Discussion ultrasound was applied to the artery and the resonance frequency was determined based on the vibration response of the blood vessel).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to second set of soundwaves of the apparatus of modified Mourad to determine the resonant frequency of the blood vessel as taught by Zhang, as this would allow for a fundamental physical measurement that would be useful as a diagnostic tool (see Zhang e172).
Regarding claim 73, modified Mourad teaches the apparatus of claim 64, wherein Mourad further teaches wherein the frequency range of the first set of sound waves is between 1Hz and 3000Hz ([0113] frequency ranges between 500 Hz to 10KHz).
Regarding claim 74, modified Mourad teaches the apparatus of claim 73, wherein Mourad further teaches wherein the frequency range of the second set of sound waves is between 670 Hz and 2300 Hz ([0113]Acoustic emissions from palpated or oscillated tissue are expected to be in the frequency range of 500 Hz to 10 KHz.)
Regarding claim 77, modified Mourad teaches the apparatus of claim 64, wherein Mourad further teaches wherein the blood vessel is an artery ([0074] the system is measuring arterial blood pressure using the properties of an artery).
Regarding claim 78, modified Mourad teaches the apparatus of claim 64, wherein Mourad further teaches wherein the at least first transducer and the second transducer are coupled to a substrate ([0132] the acoustic array, such as the ultrasound transducers, are provided as a unitary element, meaning they would be part of the same structure), the substrate comprising an adhesive backing ([0132] there is an adhesive material that is disposed on the patient’s skin as part of a disposable system element).
Regarding claim 139, modified Mourad teaches the apparatus of claim 64, wherein the at least the first transducer comprises a first emission transducer that emits the first set of soundwaves and a second emission transducer that emits the second set of soundwaves.
Claims 65 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Mourad in view of Southard and Zhang as applied to claim 64 above, and further in view of Shusterman (US20180020931A1).
Regarding claim 65, modified Mourad teaches the apparatus of claim 64, but fails to explicitly disclose wherein the first transducer is an electroacoustic transducer and the second transducer is a piezoelectric ultrasonic transducer.
In the same blood pressure field of endeavor, Shusterman teaches wherein the first transducer is an electroacoustic transducer and the second transducer is a piezoelectric ultrasonic transducer ([0013] the system may include a combination of electroacoustic sensors and piezoelectric sensors).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the apparatus of modified Mourad with the sensors of Shusterman, as this would provide flexibility when designing a use for the apparatus (see Shusterman [0013]).
Regarding claim 77, modified Mourad teaches the apparatus of claim 65, wherein Mourad further teaches wherein the blood vessel is an artery ([0074] the system is measuring arterial blood pressure using the properties of an artery).
Claims 66-68, 71, 72, and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Mourad as modified by Southard and Zhang as applied to claim 64 above, and further in view of Holland et al., (US20120130288A1).
Regarding claim 66, modified Mourad teaches the device of claim 65, but is silent regarding an audio signal generator coupled to the first transducer,
In the same ultrasound field of endeavor, Holland teaches an audio signal generator coupled to the first transducer (fig. 1 driver 30 is electrically connected to the transducer 22[0067]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the transducers of modified Mourad with the connections of Holland, as the network of connections would lead to increases of the efficiency of the ultrasonic driver ([0069]).
Regarding claim 67, modified Mourad teaches the device of claim 66, but is silent regarding the audio signal generator adjusts the frequency range of the second set of soundwaves.
In the same ultrasound field of endeavor, Holland teaches the audio signal generator adjusts the frequency range of the second set of soundwaves. (fig. 1 driver 30 is electrically connected to the transducer 22, and the driver 30 has an adjustable frequency[0067]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the transducers of modified Mourad with the connections of Holland, as the network of connections would lead to increases of the efficiency of the ultrasonic driver ([0069]).
Regarding claim 68, modified Mourad teaches the apparatus of claim 67, wherein Mourad further discloses a display ([0094] display unit).
Regarding claim 71, modified Mourad teaches the apparatus of claim 67, wherein Mourad further teaches wherein the second transducer (detection element 56) monitors a vibration of a cross section of the blood vessel ([0074] the compression/dilation of the cross section may be measured)[0128] the transducer array may be used to scan multiple target sites), records a frequency of the vibration of the cross-section ([0139]-[0140] a scan is taken, and then the oscillating frequency allows for a resonant frequency to be determined and used).
Regarding claim 72, modified Mourad teaches the apparatus of claim 71, wherein Mourad further teaches wherein the resonant frequency is determined when the vibration of the cross section of the blood vessel is at a maximum ([0140] the resonance frequency is the frequency that maximizes the acoustic emissions and is used).
Regarding claim 77, modified Mourad teaches the apparatus of claim 66-68, 71, and 72, wherein Mourad further teaches wherein the blood vessel is an artery ([0074] the system is measuring arterial blood pressure using the properties of an artery).
Claims 69, 70, and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Mourad as modified by Southard, Zhang, and Holland as applied to claim 68 above, and further in view of Bang et al.,( US 20020016547 A1)
Regarding claim 69, modified Mourad teaches the apparatus of claim 68, but is silent regarding wherein the display shows the frequency range of the sound waves.
In the same ultrasound field of endeavor, Bang teaches the display shows the frequency range of the sound waves (fig. 5 display device 309 shows frequency distribution of the ultrasonic signals [0025]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the display unit of modified Mourad with the display of Bang, as this would result in the user being able to accurately determine the noise threshold (see Bang [0008]).
Regarding claim 70, modified Mourad teaches the apparatus of claim 69, wherein Mourad further teaches wherein the second transducer monitors a vibration of a cross section of the blood vessel ([0074] the compression/dilation of the cross section may be measured).
Regarding claim 77, modified Mourad teaches the apparatus of claim 69 and 70, wherein Mourad further teaches wherein the blood vessel is an artery ([0074] the system is measuring arterial blood pressure using the properties of an artery).
Claims 65 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Mourad as modified by Lee as applied to claim 64 above, and further in view of Shusterman.
Regarding claim 65, modified Mourad teaches the apparatus of claim 64, but fails to explicitly disclose wherein the first transducer is an electroacoustic transducer and the second transducer is a piezoelectric ultrasonic transducer.
In the same blood pressure field of endeavor, Shusterman teaches wherein the first transducer is an electroacoustic transducer and the second transducer is a piezoelectric ultrasonic transducer ([0013] the system may include a combination of electroacoustic sensors and piezoelectric sensors).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the apparatus of modified Mourad with the sensors of Shusterman, as this would provide flexibility when designing a use for the apparatus (see Shusterman [0013]).
Regarding claim 77, modified Mourad teaches the apparatus of claim 65, wherein Mourad further teaches wherein the blood vessel is an artery ([0074] the system is measuring arterial blood pressure using the properties of an artery).
Claims 75 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Mourad as modified by Lee as applied to claim 65 above, and further in view of Albert.
Regarding claim 75, modified Mourad teaches the device of claim 65, but is silent regarding wherein the electroacoustic transducer is an audio speaker.
In the same ultrasound field of endeavor, Albert teaches wherein the electroacoustic transducer is an audio speaker ([0018] a sound transducer (for example a speaker capable of emitting ultrasound signals)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Mourad with the sound transducer of Albert, as this would reduce costs and complexity (see Albert [0005]).
Regarding claim 77, modified Mourad teaches the apparatus of 75, wherein Mourad further teaches wherein the blood vessel is an artery ([0074] the system is measuring arterial blood pressure using the properties of an artery).
Claims 76 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Mourad as modified by Lee and Albert as applied to claim 75 above, and further in view of Shouldice et al., (US20200367810A1).
Regarding claim 76, modified Mourad teaches the apparatus of claim 75, but fails to explicitly disclose wherein the audio speaker is a tweeter.
In the same ultrasound field of endeavor, Shouldice teaches the audio speaker is a tweeter ([0074] the speakers can be e.g. tweeters).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the speaker of modified Mourad with the tweeter of Shouldice, as this would provide improvements in automated management, and monitoring of conditions (see Shouldice [0025]).
Regarding claim 77, modified Mourad teaches the apparatus of claim 76, wherein Mourad further teaches wherein the blood vessel is an artery ([0074] the system is measuring arterial blood pressure using the properties of an artery).
Claim 79 is rejected under 35 U.S.C. 103 as being unpatentable over Mourad as modified by Southard and Zhang as applied to claim 78 above, and further in view of Joseph et al., (US20210251520A1).
Regarding claim 79, modified Mourad teaches the apparatus of claim 78, but is silent regarding further teaches wherein the substrate is adhered proximal to the blood vessel.
However in the same ultrasound field of endeavor, Joseph teaches wherein the substrate is adhered proximal to the blood vessel ([0070] sound transducer is a piezoelectric film with adhesive that adheres to the skin surface adjacent or proximal to the trachea).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the apparatus of modified Mourad with the placement of the device as taught by Joseph, as this would lead to improved clinical outcomes through efficient/effective/timely procedures (see Joseph [0072]).
Claim 80 is rejected under 35 U.S.C. 103 as being unpatentable over Mourad as modified by Southard and Zhang as applied to claim 79 above, and further in view of Chang et al., (US20080154140A1).
Regarding claim 80, modified Mourad teaches the apparatus of claim 79, but is silent regarding wherein the blood vessel is a carotid artery of the subject.
However in the same blood pressure measurement field of endeavor, Chang teaches wherein the blood vessel is a carotid artery of the subject ([0001] Carotid pulse measurement device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the apparatus of modified Mourad to measure the blood pressure of the carotid as taught by Chang, as this would allow for a more precise manner for predicting the risk of vessel diseases (see Chang [0007]).
Claim 81 is rejected under 35 U.S.C. 103 as being unpatentable over Mourad as modified by Southard and Zhang as applied to claim 78 above, and further in view of Routh et al., (US20080312562A1).
Regarding claim 81, modified Mourad teaches the apparatus of claim 78, but fails to explicitly disclose wherein the substrate comprises an alignment line.
In the same ultrasound field of endeavor, Routh teaches wherein the substrate comprises an alignment line (fig. 11 transducer cuff may have line of indicators 16 that aligns with the blood vessel [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the apparatus of modified Mourad to use an alignment line as taught by Routh, as this would quickly guide the user in correctly positioning the arrays, and thus be more effective and efficient (see Routh [0035]).
Claim 81 depending on claims 79 and 80 in view of Joseph and Chang, respectively, would be rejected for the substantially the same reasons as above.
Claim 82 is rejected under 35 U.S.C. 103 as being unpatentable over Mourad as modified by Southard and Zhang as applied to claim 78 above, and further in view of Routh and Pintel et al., (US20090234228A1).
Regarding claim 82, modified Mourad teaches the device of claim 12, but fails to explicitly disclose wherein the substrate comprises an alignment line.
In the same ultrasound field of endeavor, Routh teaches wherein the substrate comprises an alignment line (fig. 11 transducer cuff may have line of indicators 16 that aligns with the blood vessel [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the apparatus of modified Mourad to use an alignment line as taught by Routh, as this would quickly guide the user in correctly positioning the arrays, and thus be more effective and efficient (see Routh [0035]).
However the combination of references are silent regarding a transparent window.
In the same ultrasound field of endeavor, Baumann teaches wherein the substrate comprises a transparent window ([0081] the coupling material is made of a transparent rubber-like elastomer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the substrate of modified Mourad with the coupling material of Pintel, as this would help facilitate better contact of the probe with the subject’s tissue (see Pintel [0086]).
Claim 82 depending on claims 79 and 80 in view of Joseph and Chang, respectively, would be rejected for the substantially the same reasons as above.
Claim 139 is rejected under 35 U.S.C. 103 as being unpatentable over Mourad as modified by Southard and Zhang as applied to claim 64 above, and further in view of Hiltner et al., (US20170143305A1).
Regarding claim 139, modified Mourad teaches the apparatus of claim 64, but fails to explicitly disclose wherein the at least the first transducer comprises a first emission transducer that emits the first set of soundwaves and a second emission transducer that emits the second set of soundwaves.
However in the same ultrasound field of endeavor, Hiltner teaches wherein the at least the first transducer comprises a first emission transducer that emits the first set of soundwaves and a second emission transducer that emits the second set of soundwaves ([0056] a first transducer emits at a first frequency and a second transducer emits at a second frequency).
It would have been obvious to one of ordinary skill in the art to modify the apparatus of modified Mourad with the emitter transducers of Hiltner, as the transducers operating at different frequencies would allow for them to detect only specific signal frequencies, which would then facilitate physical dimension measurements (see Hiltner [0057]).
REASONS FOR ALLOWANCE
Claims 1-48, 50-62, and 136-138 are allowable.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 1, the most relevant prior art are as follows:
Mourad
Lee (US20160074017A1)
Southard
Zhang
Applicant’s arguments, see Remarks pages 27-30, filed 12/10/2025, with respect to claims 1-48 and 50-63 have been fully considered and are persuasive. The 35 U.S.C. 103 rejection of claims 1-48 and 50-63 has been withdrawn.
Specifically, Mourad teaches of a blood pressure measurement system that applies acoustic radiation to tissue causing it to induce displacement in the tissue, which is then used to determine arterial blood pressure (see Mourad [0148]-0152]). Further, Mourad teaches the use of single or multiple transducers to transmit singular or multiple frequences to induce the tissue displacement (see Mourad [0112]).
However, Mourad fails to adjust a frequency range of a set of soundwaves based on the vibrational response of the blood vessel, determine a resonant frequency of the blood vessel based on the second set of sound waves, and using that resonant frequency of the blood vessel to measure blood pressure of the subject.
Lee teaches of an ultrasound signal that is sent, a resonance frequency is identified, and then a second signal is transmitted after it has been adjusted. However, this resonance frequency is of the ultrasound transducer, and not of the blood vessel.
Southard teaches of detecting the ultrasound signals echoed off the blood vessel and received by the probe, and adjusted the operating frequency of the probe to optimize the acquired ultrasound image. However, Southard fails to disclose determining a resonant frequency of the blood vessel based on the second set of sound waves, and using that resonant frequency of the blood vessel to measure blood pressure of the subject.
Zhang teaches of ultrasound being applied to the artery and the resonance frequency was determined based on the vibration response of the blood vessel, but this resonance frequency was not determined based on an adjusted second set of sound waves, and is also not used to determine blood pressure.
Therefore, the prior art fails to explicitly teach, when considered as a whole, the limitations of claim 1. Independent claims 41 and 54 are rejected for the same reasons. The remaining dependent claims are allowable for the same reasons as above.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments with respect to claims 64-82 and 139 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. Mourad in view of Southard and Zhang have been used to teach the limitations of claim 64.
The remaining dependent claims are rejected for substantially the same reasons as above.
Conclusion
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/MICHAEL YIMING FANG/Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798