DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 08/25/2025 have been fully considered but they are not persuasive.
Regarding the amendments to the independent claims, Hoctor has been used to teach driving the cMUT with a time-varying AC voltage signal, Srinivasan has been used to teach that the sensor operates in both a force sensing and imaging mode, and newly-found reference of Emadi has been introduced to teach measuring a force by measuring a static capacitance of the sensors under a low-level DC voltage signal.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “housing element” in claim 8.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Based on the language of claim 8, “housing element” will be interpreted to be any structure capable of containing the ultrasound patch and the processor that includes an opening to allow for the passage of ultrasound energy.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 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 3 & 16 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.
Claims 3 & 16 have been amended such that the sensors are piezoelectric sensors or piezoresistive sensors. However, claims 1 & 9 have been amended such that the sensors are cMUTs. Because a sensor cannot simultaneously be a cMUT and a piezoelectric or piezoresistive sensor, the claims are indefinite. Likewise, the claims will not be examined for prior art on the merits.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 6-7, 9-10, 13-15, & 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hoctor (US 2005/0154299) in view of Srinivasan (US 2021/0153755), Emadi (US 2016/0016198), Chowienczyk (US 2011/0270098), and Xu (US 2019/0328354).
Regarding claim 1, Hoctor teaches a device for estimating the central blood pressure of a subject, the device comprising:
a sensor patch (ultrasonic transducer patch, [0046]) comprising an array of sensors (cMUTs, [0046]), wherein each sensor is a capacitive micromachines ultrasonic transducer (cMUT) ([0046]) configured to:
measure, in a first mode, an indication of blood pressure (vessel diameter, [0066] & pulse wave velocity, [0067]) of a peripheral blood vessel ([0051]; brachial artery, [0083]); and
perform, in a second mode, ultrasound imaging on the peripheral blood vessel ([0066]-[0067]) by driving the cMUT with a time-varying AC voltage signal ([0056]), wherein the same sensors are used for blood pressure measurement in the first mode and ultrasound imaging in the second mode ([0066]-[0067]); and
a processor (portable personal computer, [0051]) configured to:
obtain a peripheral pressure signal ([0072]-[0073]) comprising a pressure waveform ([0046]) from the indication of a blood pressure from the sensor patch ([0072]-[0073]);
Paragraph [0046] teaches that the invention is drawn to continuous blood pressure monitoring; therefore, the pressure signals would comprise waveforms. Likewise, per Equation 7 of [0072], blood pressure P(t) is a function of time.
derive an image of the peripheral blood vessel from the ultrasound imaging from the sensor patch ([0066]-[0067]); and
determine a vessel diameter from the image of the peripheral blood pressure over time as a vessel diameter waveform ([0066]; [0072]-[0073]).
Per Equation 7 of [0072], A(t) is a function of time, and area is a function of diameter. Thus, the diameter measurements are continuous waveforms.
However, Hoctor fails to disclose that each sensor is configured to operate in a force sensing mode and an ultrasound imaging mode; and the indication of blood pressure of the peripheral blood vessel is made based on a force at skin of the subject.
Srinivasan teaches that each sensor (force or displacement sensors 550, [0055]) is configured to operate in a force sensing mode ([0055]) and an ultrasound imaging mode ([0055] & [0060]); and the indication of blood pressure of the peripheral blood vessel is made based on a force at skin of the subject ([0003] & [0055]).
Paragraph [0055] teaches that the force or displacement sensors 550 may be capacitive elements. The device of [0055] is also a TBPI (Tactile Blood Pressure Imager, per [0033]). Thus, the sensors taught in [0055] are capable of both force sensing and imaging.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Hoctor such that each sensor is configured to operate in a force sensing mode and an ultrasound imaging mode; and the indication of blood pressure of the peripheral blood vessel is made based on a force at skin of the subject, as taught by Srinivasan. Combining the functions of force sensing and imaging into one sensor simplifies the overall design and consolidates the device.
However, Hoctor in view of Srinivasan fail to disclose that the force is measured by measuring a static capacitance of the sensors under a low-level DC voltage signal.
Emadi teaches that the force is measured ([0138]-[0139) by measuring a static capacitance of the sensors under a low-level DC voltage signal ([0127]-[0128]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Hoctor and Srinivasan such that the force is measured by measuring a static capacitance of the sensors under a low-level DC voltage signal, as taught by Emadi. This is a well-known method of measuring forces and allows the force of the patient’s pulse wave to be translated into a blood pressure value.
However, Hoctor in view of Srinivasan and Emadi fail to disclose deriving an estimate of the central blood pressure waveform of the subject from the pressure waveform.
Chowienczyk teaches deriving an estimate of the central blood pressure waveform of the subject from the pressure waveform ([0025]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device taught by Hoctor to include deriving an estimate of the central blood pressure waveform of the subject from the pressure waveform, as taught by Chowienczyk. Because the peripheral blood pressure is easily obtainable and the central blood pressure is difficult to measure non-invasively, this provides a convenient and reliable method for measuring the central blood pressure.
However, Hoctor in view of Srinivasan, Emadi, and Chowienczyk fail to disclose deriving an estimate of the central blood pressure waveform of the subject from the vessel diameter waveform.
Xu teaches deriving an estimate of the central blood pressure waveform of the subject from the vessel diameter waveform (“the device can continuously detect the pulsating blood vessel diameter change, which can be translated into CBP waveforms”, [0139]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Hoctor, Srinivasan, Emadi, and Chowienczyk to include deriving an estimate of the central blood pressure waveform of the subject from the vessel diameter waveform, as taught by Xu. Because the vessel diameter is easily obtainable and the central blood pressure is difficult to measure non-invasively, this provides a convenient and reliable method for measuring the central blood pressure, and an additional method over the pressure waveform.
Regarding claim 2, Hoctor in view of Srinivsan, Emadi, Chowienczyk, and Xu teach the device of claim 1, and Hoctor further teaches that the processor is configured to: determine the vessel diameter by applying an automatic tracking algorithm (algorithm that tracks arterial diameter, [0085]) to the image of the peripheral blood vessel in color Doppler mode ([0065] & [0067]).
Paragraph [0067] teaches that Doppler (M-mode) is used to acquire vessel information. Paragraph [0065] teaches that color flow imaging can instead be used in location and tracking of the artery. Paragraphs [0112]-[0113] further note the similarities between color flow imaging and Doppler imaging.
Regarding claim 6, Hoctor in view of Srinivsan, Emadi, Chowienczyk, and Xu teach the device of claim 1, and Chowienczyk further teaches that the processor is further adapted to: calibrate a mean value and a diastolic value of the estimated central blood pressure (pressure waveform obtained after applying the transfer function, [0083]) to a cuff mean value and a cuff diastolic value obtained from pressure cuff measurements (cuff waveforms, [0083]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device taught by Hoctor such that the processor is further adapted to: calibrate a mean value and a diastolic value of the estimated central blood pressure to a cuff mean value and a cuff diastolic value obtained from pressure cuff measurements, as taught by Chowienczyk. Per [0004] of Chowienczyk, mean and diastolic blood pressure values are similar between central and peripheral vessels. Therefore, the accuracy of the estimated central blood pressure can be compared to the pressure cuff measurements.
Regarding claim 7, Hoctor in view of Srinivsan, Emadi, Chowienczyk, and Xu teach the device of claim 1, and Hoctor further teaches that the processor is further configured to transform the vessel diameter waveform to a second pressure waveform for the peripheral blood vessel ([0072]-[0073]).
Because the vessel diameter is used to estimate the blood pressure continuously, any subsequent blood pressure estimation derived from a different cardiac cycle or measurement period can be considered the second pressure waveform.
Chowienczyk further teaches that the processor is configured to derive the estimate of the central blood pressure waveform of the subject from the pressure waveform ([0025]).
Claim 9 is rejected for similar reasons to claim 1.
Claim 10 is rejected for similar reasons to claim 2.
Claim 13 is rejected for similar reasons to claim 6.
Claim 14 is rejected for similar reasons to claim 7.
Claim 18 is rejected for similar reasons to claim 2.
Regarding claim 15, Hoctor teaches a non-transitory computer readable medium (portable personal computer, [0051]), that stores therein a computer program product (software, [0045]), which, when executed on a processor, causes the method of claim 9 to be performed (See rejection of claim 1).
Claims 4-5, 11-12, & 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hoctor in view of Srinivsan, Emadi, Chowienczyk, and Xu, as applied to claims 1 & 9, above, in further view of Schmitt (US 2020/0229716) and Bouwman (US 2019/0380593).
Regarding claim 4, Hoctor in view of Srinivsan, Emadi, Chowienczyk, and Xu teach the device of claim 1.
However, Hoctor in view of Srinivsan, Emadi, Chowienczyk, and Xu fail to disclose that the processor is further adapted to: determine a quality factor for each of a plurality of peripheral pressure waveform cycles of the pressure waveform; and create an ensemble pressure waveform based on the pressure waveform cycles and their respective quality factors.
Schmitt teaches that the processor is further adapted to:
determine a quality factor (signal-to-noise ratio, [0026]) for each of a plurality of peripheral pressure waveform cycles of the pressure waveform (blood pressure estimation values, [0025]); and
create an ensemble pressure waveform (single blood pressure estimation value, [0025]) based on the pressure waveform cycles and their respective quality factors ([0025]-[0026]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device taught by Hoctor, Srinivsan, Emadi, Chowienczyk, and Xu such that the processor is further adapted to: determine a quality factor for each of a plurality of peripheral pressure waveform cycles of the pressure waveform; and create an ensemble pressure waveform based on the pressure waveform cycles and their respective quality factors, as taught by Schmitt. This allows the processor to smooth out any outliers, creating a more representative and accurate blood pressure waveform.
However, Hoctor in view of Srinivsan, Emadi, Chowienczyk, Xu, and Schmitt fail to disclose that the processor is further adapted to: determine a quality factor for each of a plurality of vessel diameter waveform cycles of the vessel diameter waveform; and create an ensemble diameter waveform based on the vessel diameter waveform cycles and their respective quality factors.
Bouwman teaches that the processor is further adapted to:
determine a quality factor (predefined or dynamic threshold value, [0110]) for each of a plurality of vessel diameter waveform cycles of the vessel diameter waveform (vessel diameters, [0110]); and
create an ensemble diameter waveform (reference diameter area computation, [0110]) based on the vessel diameter waveform cycles and their respective quality factors ([0110]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device taught by Hoctor, Srinivsan, Emadi, Chowienczyk, Xu, and Schmitt such that the processor is further adapted to: determine a quality factor for each of a plurality of vessel diameter waveform cycles of the vessel diameter waveform; and create an ensemble diameter waveform based on the vessel diameter waveform cycles and their respective quality factors, as taught by Bouwman. This allows the processor to smooth out any outliers, creating a more representative and accurate vessel diameter waveform.
The teaching of Chowienczyk in which the central blood pressure is estimated based on the pressure waveform would not change if substituting the pressure waveform for the ensemble pressure waveform. Thus, the combination of Chowienczyk and Schmitt teach that estimating the central blood pressure is based on the ensemble pressure waveform.
Regarding claim 5, Hoctor in view of Srinivsan, Emadi, Chowienczyk, Xu, Schmitt, and Bouwman teach the device of claim 4, and Chowienczyk further teaches that the processor is adapted to derive an estimate of the central blood pressure by:
applying a frequency-based transfer function (transfer function H, [0064]) to the ensemble pressure waveform ([0064]-[0071]); or
using a physics-based model (IIR filter (ARX model), [0072]) to transform the ensemble pressure waveform to an estimate of the central blood pressure ([0072]-[0081]).
Under the combination of Chowienczyk and Schmitt, the pressure waveform would be the ensemble pressure waveform.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device taught by Hoctor such that the processor is adapted to derive an estimate of the central blood pressure by: applying a frequency-based transfer function to the ensemble pressure waveform; or using a physics-based model to transform the ensemble pressure waveform to an estimate of the central blood pressure, as taught by Chowienczyk. Per Chowienczyk, these functions/models are useful in transforming abstract signals into usable data.
Claim 11 is rejected for similar reasons to claim 4.
Claim 12 is rejected for similar reasons to claim 5.
Claim 19 is rejected for similar reasons to claim 4.
Claim 20 is rejected for similar reasons to claim 5.
Claims 8 & 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hoctor in view of Srinivsan, Emadi, Chowienczyk, and Xu, as applied to claim 1, above, in further view of Rothberg (US 2019/0343484).
Regarding claim 8, Hoctor in view of Srinivsan, Emadi, Chowienczyk, and Xu teach the device of claim 1.
However, Hoctor in view of Srinivsan, Emadi, Chowienczyk, and Xu fail to disclose: a housing element for housing the sensor patch and the processor, wherein the housing element comprises an opening and wherein the opening is for a sensing area of the sensor patch; a strap attached to the housing element; and a skin interface at the opening of the housing element.
Rothberg teaches:
a housing element (lower housing 116, [0052]) for housing the sensor patch (ultrasound patch 110, [0051]) and the processor (circuit board 118, [0053]), wherein the housing element comprises an opening (116, Figure 3) and wherein the opening is for a sensing area of the sensor patch (Figure 3);
a strap (strap 600, [0059]) attached to the housing element ([0059]); and
a skin interface at the opening of the housing element (Figure 3).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device taught by Hoctor, Srinivsan, Emadi, Chowienczyk, and Xu to include: a housing element for housing the sensor patch and the processor, wherein the housing element comprises an opening and wherein the opening is for a sensing area of the sensor patch; a strap attached to the housing element; and a skin interface at the opening of the housing element, as taught by Rothberg. The housing element provides structural support to the sensor patch, the opening provides a window through which the ultrasound can pass, and the strap secures the ultrasound patch at the desired location of the subject.
Claim 17 is rejected for similar reasons to claim 8.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM KOLKIN whose telephone number is (571)272-5480. The examiner can normally be reached Monday-Friday 1:00PM-10:00PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached on (572)-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798