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 04/22/2026 have been fully considered but they are not persuasive.
Rejections under 35 USC 112 have been withdrawn.
Applicant argues, see Applicant’s arguments pages 10-13, that the combination of Joseph, Pearson, and Goto fail to disclose extracting a pulse wave pattern across a segment of an artery over which a flow restrictor is positioned, wherein the pulse wave pattern includes regional stiffness indices, and measuring early vascular health markers based on the local and regional stiffness indices. First, the term “segment” is not defined in the claim; it is unclear if “segment” refers to the section of the artery downstream from the flow restrictor or the length of the artery that is traversed by the flow restrictor. Paragraph [0040] & Figure 4 of Pearson teach that the transducers are provided within the sphygmomanometer cuff. Therefore, the pulse wave patterns will be extracted from the length of the artery that is traversed by the flow restrictor. Paragraph [0040] also teaches that the transducers can be disposed downstream of the cuff. Second, page 10 of the instant specification details what comprises a local or regional stiffness index. Local pulse wave velocity and local pulse transit time are listed as local stiffness indices, and pulse transit time is listed as a regional stiffness index. Paragraphs [0040], [0075], & [0151] of Joseph teach determining local and regional stiffness indices. Examiner upholds the combination of Joseph and Pearson to measure regional stiffness indices across the segment of the artery with the flow restrictor, as Pearson teaches in [0040]-[0041] that a transducer incorporated in a cuff can measure blood flow velocity, and Joseph in [0151] teaches measuring pulse transit time from sensors incorporated in straps placed over two parts of a patient’s body. Finally, page 7 of the instant specification & claim 4 define “early vascular health markers” as “regional stiffness indices, local stiffness indices, and assessment of endothelial function”. Joseph teaches measuring regional and local stiffness indices, and Sheehan is introduced to teach assessing vascular function. Thus, Examiner asserts that the combination of Joseph, Pearson, and Goto, as well as Sheehan, teach the full scope of the claim, and the combination of references has been upheld.
Claim Objections
Objections to the claims have been withdrawn in response to Applicant’s amendments filed 04/22/2026.
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: “ultrasound module” in claims 1 & 16, “pulse detection module” in claims 1 & 16, “measurement module” in claims 1 & 16, “high voltage generation module” in claim 6, “automatic artery wall detection module” in claim 9, “wall tracking module” in claim 10, “diameter waveform generator module” in claim 11, “synchronized automatic cycle cutting and selection (SAC) module” in claim 12, “proximal diameter cycle module” in claim 12, “local stiffness evaluation module” in claim 12, “beat-to-beat diameter generation module” in claim 13, “segregation module” in claim 13, “phasic diameter evaluation module” in claim 13, “endothelial function module” in claim 13, “distal pulse wave module” in claim 14, “processing module” in claim 14, and “distal pulse cycle module” in claim 14.
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.
Regarding Figure 2A, the ultrasound module, pulse detection module and high voltage generation module will be interpreted as hardware components capable of performing their respective claimed functions.
Regarding Figure 2B, the measurement module, automatic artery wall detection module, wall tracking module, diameter waveform generation module, synchronized automatic cycle cutting and selection (SAC) module, proximal diameter cycle module, local stiffness evaluation module, beat-to-beat diameter generation module, segregation module, phasic diameter evaluation module, endothelial function module, distal pulse wave module, processing module, and distal pulse cycle module will be interpreted as software components capable of performing their respective claimed functions.
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.
Rejections under 35 USC 112 have been withdrawn in response to Applicant’s amendments filed 04/22/2026.
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 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 1-3, 5-11, & 16 are rejected under 35 U.S.C. 103 as being unpatentable over Joseph (US 2017/0156706) in view of Pearson (US 2015/0366474) and Goto (US 2001/0037068).
Regarding claim 1, Joseph teaches an image-free ultrasound system for simultaneous, continuous, and real-time non-invasive assessment of early vascular health markers comprising:
one or more ultrasound transducers (sensor 102, [0040]) positioned on at least one first artery ([0040]), wherein the ultrasound transducers generate first signals based on blood flow and pulse propagation in said at least one first artery ([0040]);
an ultrasound module (sensor 102, [0040]) in communication with each ultrasound transducer, wherein the ultrasound module generates characteristic waves (first and second pulse waveforms, [0040]) based on the generated signals at the ultrasound transducers ([0040]), said characteristic waves include indices of local stiffness (local pulse wave velocity (PWV), [0040] & local PTT, [0075]) in said first artery ([0040] & [0075]); and
The sensor 102 taught by Joseph performs the claimed functions of both the ultrasound transducers and ultrasound module.
Page 10 of the instant specification teaches that local stiffness indices may include local pulse wave velocity and local pulse transit time (PTT).
a measurement module (sensor 102, [0040]) controlled by at least one processor ([0048]), wherein the measurement module is in communication with the ultrasound module to receive the generated characteristic waves, wherein the early vascular health markers are measured by the measurement module based on the indices of local stiffness ([0040] & [0075]) and indices of regional stiffness (PTT, [0151]).
The sensor 102 taught by Joseph further performs the claimed functions of the measurement module. Additionally, page 10 of the instant specification teaches that regional stiffness indices may include pulse transit time (PTT).
However, Joseph fails to disclose: one or more flow restrictors positioned over a segment of at least one second artery to partially restrict blood flow in said second artery, wherein the flow restrictors generate second signals based on the blood flow in said second artery; a pulse detection module in communication with each flow restrictor, wherein the pulse detection module extracts from said second signal a pulse wave pattern across said segment, said pulse wave pattern includes indices of regional stiffness in said segment; and the measurement module controlled by at least one processor, wherein the measurement module is in communication with the pulse detection module to receive the generated pulse waves.
Pearson teaches:
one or more flow restrictors (sphygmomanometer cuff 22, [0034]) positioned over a segment of at least one second artery to partially restrict blood flow in said second artery ([0034]), wherein the flow restrictors generate second signals (return signal 27, [0041]) based on the blood flow in said second artery ([0041]);
a pulse detection module (one or more transducers 25, [0040]) in communication with each flow restrictor ([0040]), wherein the pulse detection module extracts from said second signal a pulse wave pattern across said segment, said pulse wave pattern includes indices of regional stiffness (velocity of blood flow through the blood vessel 30, [0041]) in said segment ([0041]); and
Page 10 of the instant specification teaches that regional stiffness indices may include pulse wave velocity.
the measurement module (apparatus 50, [0035]) controlled by at least one processor (processor 60, [0035]), wherein the measurement module is in communication with the pulse detection module to receive the generated pulse waves ([0041]).
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 system taught by Joseph to include: one or more flow restrictors positioned over a segment of at least one second artery to partially restrict blood flow in said second artery, wherein the flow restrictors generate second signals based on the blood flow in said second artery; a pulse detection module in communication with each flow restrictor, wherein the pulse detection module extracts from said second signal a pulse wave pattern across said segment, said pulse wave pattern includes indices of regional stiffness in said segment; and the measurement module controlled by at least one processor, wherein the measurement module is in communication with the pulse detection module to receive the generated pulse waves, as taught by Pearson. The combination of flow restrictors and pulse detection modules allows for cardiovascular data to be obtained, while the measurement module can analyze the data to determine any abnormalities.
However, Joseph in view of Pearson fail to disclose that the second signals are generated by capturing artery pulsations with maximum amplitude.
Goto teaches that the second signals are generated by capturing artery pulsations with maximum amplitude (maximum pulse having the greatest amplitude of respective amplitudes, [0109]).
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 system of Joseph and Pearson such that the second signals are generated by capturing artery pulsations with maximum amplitude, as taught by Goto. This ensures the system captures the highest-quality signals, as these signals will have the highest possible SNR.
Regarding claim 2, Joseph in view of Pearson and Goto teach the image-free ultrasound system as claimed in claim 1, and Goto further teaches that each flow restrictor (cuff 10, [0067]) is inflated to optimal pressure levels (pressure PHD, [0109]) to occlude and partially restrict the blood flow in the artery ([0077] & [0109]), wherein the flow restrictor captures artery pulsations with maximum amplitude ([0109]).
Per [0077], the mean BP value is the pressure at which pulses having a maximum amplitude are produced. Any pressure between the systolic and diastolic blood pressures would partially restrict blood flow.
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 system of Joseph and Pearson such that each flow restrictor is inflated to optimal pressure levels to occlude and partially restrict the blood flow in the artery, wherein the flow restrictor captures artery pulsation with maximum amplitude, as taught by Goto. This ensures the system captures the highest-quality signals, as these signals will have the highest possible SNR.
Regarding claim 3, Joseph in view of Pearson and Goto teach the image-free ultrasound system as claimed in claim 1, and Goto further teaches that as the flow restrictor is inflated, pressure fluctuations (“The pulse wave is a pressure oscillation which is transmitted from the arteries (e.g., brachial artery) of the living subject to the cuff 10”, [0068]) are generated within a fluid column ([0068]) of the flow restrictor over the baseline inflation pressure (static pressure, Pc, [0068]), wherein the second signal that is generated at the flow restrictor is a pressure signal with a direct current (DC) component based on inflation pressure ([0068]) and an alternating current (AC) component ([0068]).
Cuff 10 is filled with air. Air is a fluid.
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 system of Joseph and Pearson such that as the flow restrictor is inflated, pressure fluctuations are generated within a fluid column of the flow restrictor over the baseline inflation pressure, wherein the second signal that is generated at the flow restrictor is a pressure signal with a direct current (DC) component based on inflation pressure and an alternating current (AC) component, as taught by Goto. The oscillating AC component allows the pressure from the pulse waves to be detected over the constant DC component of the inflation pressure.
Regarding claim 5, Joseph in view of Pearson and Goto teach the image-free ultrasound system as claimed in claim 1, and Joseph further teaches that the ultrasound transducer is a single-element ultrasound transducer ([0077]).
Regarding claim 6, Joseph in view of Pearson and Goto teach the image-free ultrasound system as claimed in claim 1, and Joseph further teaches that the ultrasound module comprises:
a high voltage generation module (high frequency high voltage pulser, [0091]);
a transceiver (ultrasound signal acquisition circuitry, [0091]) in communication with the high voltage generation module to generate high-voltage excitation pulses for the ultrasound transducer based on control signals from the ultrasound transducer ([0044]) provided by the microcontroller ([0044] & [0091]-[0092]), wherein the generated high-voltage excitation pulses enable the ultrasound transducer to send ultrasound signals into tissue ([0044]), and subsequently receive scattered back ultrasound signals from various tissue interfaces ([0044]) to generate the first signals and characteristic waves based on the dynamic motion of the artery and the local arterial stiffness of that artery ([0092]);
a transceiver switch (transmit-receive switch, [0091]) positioned between the ultrasound transducer and the transceiver; and
a microcontroller (controller unit 106, [0092]) in communication with the transceiver switch and the transceiver ([0092]), wherein the transceiver switch is operated based on a pulse control logic that is applied to the transceiver switch via the microcontroller ([0091]), wherein the pulse control logic is developed based on the high-voltage excitation pulses generated in the transceiver ([0044] & [0091]).
Paragraph [0091] teaches that the ultrasound signal acquisition circuitry includes a high speed digitizer. Because the ultrasound transducer 104 converts ultrasound signals into voltage pulses ([0044]), and these signals are digitized and communicated to the controller unit 106 ([0091]-[0092]), this satisfies the limitation that the transceiver switch is operated based on a pulse control logic.
Regarding claim 7, Joseph in view of Pearson and Goto teach the image-free ultrasound system as claimed in claim 1, and Pearson further teaches that the pulse detection module comprises:
an actuator controller (transducer 25, [0041]), wherein the flow restrictor identifies the real-time pulse wave propagation pattern at the artery and generates the second signals ([0041]), and information regarding the second signals is communicated to the actuator controller ([0041]), and wherein the actuator controller transmits the information to the microcontroller (microprocessor device, [0035]); and
a pulse wave detector (transducer 25, [0041]) that detects pulse wave patterns from the received second signals from the flow restrictor ([0041]), wherein the pulse wave detector transmits the detected pulse wave patterns to the microcontroller ([0041]).
The one or more transducers 25 are further able to serve as the claimed actuator controller and pulse wave detector; as taught in [0041] of Pearson, the transducers 25 (which are integrated into the sphygmomanometer cuff 22) detect the return signals 27 and relay them to the processor 60.
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 system taught by Joseph such that the pulse detection module comprises: an actuator controller, wherein the flow restrictor identifies the real-time pulse wave propagation pattern at the artery and generates the second signals, and information regarding the second signals is communicated to the actuator controller, and wherein the actuator controller transmits the information to the microcontroller; and a pulse wave detector detects pulse wave patterns from the received second signals from the flow restrictor, wherein the pulse wave detector transmits the detected pulse wave patterns to the microcontroller, as taught by Pearson. The actuator controller and pulse wave detector serve as bridges between the data acquisition functionalities of the invention and the data processing functionalities. Communicating the pulse signals to the microcontroller allow them to be analyzed in order to determine a patient’s vascular health.
Regarding claim 8, Joseph in view of Pearson and Goto teach the image-free ultrasound as claimed in claim 7, and Goto further teaches that the actuator controller (control device 128, [0106] & [0109]) controls inflation of the flow restrictor to an optimal pressure (pressure PHD, [0109]) based on information regarding instantaneous baseline pressure of the flow restrictor to check whether the flow restrictor is inflated to the optimal pressure ([0106] & [0109]), wherein the instantaneous baseline pressure (static pressure, Pc, [0068]) is indicated by a direct current (DC) component of the second signal generated at the flow restrictor ([0068]) and the amplitude of the alternating current (AC) component of the second signal ([0068]), wherein the actuator controller transmits the information regarding the baseline pressure of the flow restrictor to the microcontroller (cuff-pressure regulating device 178, [0106]) and receives a digital control logic that is required to control the inflation of the flow restrictor ([0106] & [0109]).
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 system of Joseph and Pearson such that the actuator controller controls inflation of the flow restrictor to an optimal pressure based on information regarding instantaneous baseline pressure of the flow restrictor to check whether the flow restrictor is inflated to the optimal pressure, wherein the instantaneous baseline pressure is indicated by a direct current (DC) component of the second signal generated at the flow restrictor and the amplitude of the alternating current (AC) component of the second signal, wherein the actuator controller transmits the information regarding the baseline pressure of the flow restrictor to the microcontroller and receives a digital control logic that is required to control the inflation of the flow restrictor, as taught by Goto. This provides a feedback system for sensing the pressure of the cuff in order to maintain the optimal pressure while performing measurements.
Regarding claim 9, Joseph in view of Pearson and Goto teach the image-free ultrasound system as claimed in claim 1, and Joseph further teaches that the microcontroller (controller unit 106, [0040]) generates ultrasound echo frames based on the characteristic waves from the ultrasound module ([0044]), wherein the ultrasound echo frames are transmitted to an automatic artery wall detection module (ultrasound transducer 104, [0044]) of the measurement module, wherein the automatic artery wall detection module identifies wall boundaries of the artery ([0044]).
As taught in [0044], the ultrasound transducer 104 performs the claimed function of the automatic artery wall detection module.
Regarding claim 10, Joseph in view of Pearson and Goto teach the image-free ultrasound system as claimed in claim 1, and Joseph further teaches that the measurement module comprises a wall tracking module (ultrasound transducer 104, [0044]) that traces continuous movement of the identified wall boundaries of the arteries and produces continuous motion pattern of the detected arterial wall boundaries ([0045]).
In addition to identifying the arterial walls, the ultrasound transducer 104 is also able to track their motion, this further taught in [0045].
Regarding claim 11, Joseph in view of Pearson and Goto teach the image-free ultrasound system as claimed in claim 8, and Joseph further teaches that the measurement module comprises a diameter waveform generator module (ultrasound transducer 104, [0044]) that receives the traced continuous movement of the identified wall boundaries and waveforms based on the continuous motion pattern from the wall tracking module to generate a diameter (end-diastolic diameter, [0046]) and distension waveform (arterial distension, [0045]), and characteristic waveforms linked to motion of the artery walls ([0066]).
The ultrasound transducer 104 is able to measure an end-diastolic diameter and arterial distension, further serving as the claimed diameter waveform generator module.
Claim 16 is rejected for similar reasons to claim 1.
Claims 4 & 12 are rejected under 35 U.S.C. 103 as being unpatentable over Joseph in view of Pearson and Goto, as applied to claims 1 & 11, above, in further view of Sheehan (US 2014/0276059).
Regarding claim 4, Joseph in view of Pearson and Goto teach the image-free ultrasound system as claimed in claim 1, and Joseph further teaches that the early vascular health markers comprise regional stiffness indices (PTT, [0151]) and local stiffness indices (local pulse wave velocity (PWV), [0040] & local PTT, [0075]).
Page 9 of the specification of the claimed invention teaches that regional stiffness indices may include pulse transit time (PTT). Pages 8-9 further teach that local stiffness indices may include local pulse wave velocity and local PTT.
However, Joseph in view of Pearson and Goto fail to disclose that the early vascular health markers comprise an assessment of endothelial function.
Sheehan teaches that the early vascular health markers comprise an assessment of endothelial function ([0043]).
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 system taught by Joseph, Pearson, and Goto such that the early vascular health markers comprise an assessment of endothelial function, as taught by Sheehan. Early detection of endothelial dysfunction is integral to treat or slow the progression of heart disease.
Regarding claim 12, Joseph in view of Pearson and Goto teach the image-free ultrasound system as claimed in claim 11, and Joseph further teaches a local stiffness evaluation module (ultrasound transducer 104, [0068]) that generates the local stiffness indices ([0068]).
Paragraph [0068] teaches that the ultrasound transducer 104 is able to measure the local PWV. Thus, the ultrasound transducer can further read on the local stiffness evaluation module.
However, Joseph in view of Pearson and Goto fail to disclose that the measurement module further comprises: a synchronized automatic cycle cutting and selection (SAC) module that receives the diameter and distension waveform, wherein the SAC module extracts boundaries of the signal for individual cardiac cycles from the received waveform, wherein the SAC module further shares the signal boundaries to a proximal diameter cycle module; the proximal diameter cycle module measures signal magnitude and characteristics for individual cardiac cycles.
Sheehan teaches that the measurement module further comprises:
a synchronized automatic cycle cutting and selection (SAC) module (software, [0033]) that receives the diameter and distension waveform ([0046]), wherein the SAC module extracts boundaries of the signal for individual cardiac cycles from the received waveform ([0046]), wherein the SAC module further shares the signal boundaries to a proximal diameter cycle module ([0046]); and
the proximal diameter cycle module (software, [0033]) measures signal magnitude and characteristics for individual cardiac cycles ([0046]).
Paragraph [0046] teaches that electrocardiograph gating is used to differentiate cardiac cycles and measure arterial diameter at the same time in a cardiac cycle to ensure accurate and consistent data. From these ultrasound signals, diameter and change in diameter can be assessed from a cycle. It is suggested in [0033] that software is integrated to perform both the functions of the claimed SAC module and proximal diameter cycle module.
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 system taught by Joseph, Pearson, and Goto such that the measurement module further comprises: a synchronized automatic cycle cutting and selection (SAC) module that receives the diameter and distension waveform, wherein the SAC module extracts boundaries of the signal for individual cardiac cycles from the received waveform, wherein the SAC module further shares the signal boundaries to a proximal diameter cycle module; the proximal diameter cycle module measures signal magnitude and characteristics for individual cardiac cycles, as taught by Sheehan. The ability to extract and measure data from individual cardiac cycles allows for more data to be obtained, providing multiple cardiac cycles to which to compare signals.
Claim 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Joseph in view of Pearson, Goto, and Sheehan, as applied to claim 12, above, in further view of Selzer (US 2004/0116813).
Regarding claim 13, Joseph in view of Pearson, Goto, and Sheehan teach the image-free ultrasound system as claimed in claim 12, and Sheehan further teaches that the measurement module comprises:
a beat-to-beat diameter generation module (software, [0033]) in communication with the diameter waveform generator module, wherein the diameter and distension waveform from the diameter waveform generator module is communicated to the beat-to-beat diameter generation module that measures diastolic diameter values (minimal (end-diastolic) diameter, [0037]) from each cardiac beat ([0037] & [0046]);
As suggested in [0033], the software is further integrated to perform the functions of the claimed beat-to-beat diameter generation module.
a segregation module (software, [0033]) in communication with the beat-to-beat diameter generation module, wherein the segregation module receives the diastolic diameter values ([0037]) and segregates diameter values for baseline state (baseline diameter, [0046]), low flow state (end diastole, [0046]), and vasodilation state (end systole, [0046]) of the cardiac cycles ([0046]); and
As suggested in [0033], the software is further integrated to perform the functions of the claimed segregation module. Additionally, [0046] teaches that electrocardiograph gating can be used to measure artery diameter at different points of the cardiac cycle. This includes baseline diameter, low flow state (i.e. end diastole, as the onset of the R wave is the point in the cardiac cycle in which blood is in its lowest flow state), and vasodilation state (i.e. end systole, as the peak of the T wave is the point in the cardiac cycle in which the arteries are most dilated).
an endothelial function module (software, [0033]) measures magnitude change and characteristics of the generated baseline (baseline diameter, [0046]), peak dilated (end systole, [0046]), and recovery diameter (end diastole, [0046]), and assesses the endothelial function ([0043]).
As suggested in [0033], the software is further integrated to perform the functions of the claimed endothelial function module. Here, the peak dilated diameter corresponds to the vasodilation state, and recovery diameter corresponds to the low flow state.
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 system taught by Joseph, Pearson, and Goto such that the measurement module comprises: a beat-to-beat diameter generation module in communication with the diameter waveform generator module, wherein the diameter and distension waveform from the diameter waveform generator module is communicated to the beat-to-beat diameter generation module that measures diastolic diameter values from each cardiac beat; a segregation module in communication with the beat-to-beat diameter generation module, wherein the segregation module receives the diastolic diameter values and segregates diameter values for baseline state, low flow state, and vasodilation state of the cardiac cycles; and an endothelial function module measures magnitude change and characteristics of the generated baseline, peak dilated, and recovery diameter, and assesses the endothelial function, as taught by Sheehan. These modules ensure that measured diameters are compared to diameters corresponding to the identical point in the cardiac cycle. Comparing the change in arterial diameter throughout the cardiac cycle can help determine the presence of arterial stiffness in order to diagnose cardiovascular disease.
However, Joseph in view of Pearson, Goto, and Sheehan fail to disclose a phasic diameter evaluation module that generates average diameter values.
Selzer teaches a phasic diameter evaluation module (computer processing system 48, [0062]) that generates average diameter values ([0081]).
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 system system taught by Joseph, Pearson, Goto, and Sheehan to include a phasic diameter evaluation module that generates average diameter values, as taught by Selzer. Selzer teaches in [0081] that the maximum and minimum diameters of an artery can be averaged over successive cardiac cycles to calculate arterial stiffness indices. Obtaining averages of arterial diameter measurements produces smoother, more reliable data.
Regarding claim 14, Joseph in view of Pearson, Goto, and Sheehan teach the image-free ultrasound system as claimed in claim 12, and Pearson further teaches that the measurement module further comprises:
a distal pulse wave module (apparatus 50, [0041]) that receives the pulse wave generated by pulse wave detector from the microcontroller ([0041]), wherein the distal pulse wave module:
generates distal pulse waves based on the pulse wave patterns ([0041]) and communicates the pulse wave to a processing module (processor 60, [0041]) that processes the distal pulse wave ([0041]).
Here, the apparatus 50 (which includes the processor 60) receives and processes the return signal 27. Thus, the apparatus 50 and processor 60 read on the claimed distal pulse wave module and processing module, respectively.
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 system taught by Joseph such that the measurement module further comprises: a distal pulse wave module that receives the pulse wave generated by pulse wave detector from the microcontroller, wherein the distal pulse wave module generates distal pulse waves based on the pulse wave patterns and communicates the pulse wave to a processing module that processes the distal pulse wave, as taught by Pearson. These modules facilitate the communication of the pulse waves such that they can be processed to diagnose cardiovascular disease.
However, Joseph in view of Pearson fail to disclose that the distal pulse wave module communicates the processed digital pulse wave to the SAC module, wherein the SAC module extracts pulse signal of individual cardiac cycles by synchronizing with the proximal diameter cycle module.
Sheehan teaches that the distal pulse wave module (software, [0033]) communicates the processed digital pulse wave to the SAC module ([0037] & [0046]), wherein the SAC module extracts pulse signal of individual cardiac cycles by synchronizing with the proximal diameter cycle module ([0046]).
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 system taught by Joseph, Pearson, and Goto such that the distal pulse wave module communicates the processed digital pulse wave to the SAC module, wherein the SAC module extracts pulse signal of individual cardiac cycles by synchronizing with the proximal diameter cycle module, as taught by Sheehan. The ability to extract and measure data from individual cardiac cycles allows for more data to be obtained, providing multiple cardiac cycles to which to compare signals.
However, Joseph in view of Pearson, Goto, and Sheehan fail to disclose a distal pulse cycle module that collates the extracted pulse signal from each cardiac beat, wherein the distal pulse cycle module generates the regional stiffness indices.
Selzer teaches a distal pulse cycle module (computer processing system 48, [0062]) that collates the extracted pulse signal from each cardiac beat ([0081]), wherein the distal pulse cycle module generates the regional stiffness indices ([0081]).
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 system system taught by Joseph, Pearson, Goto, and Sheehan to include a distal pulse cycle module that collates the extracted pulse signal from each cardiac beat, wherein the distal pulse cycle module generates the regional stiffness indices, as taught by Selzer. Collecting the pulse signal from each cardiac cycle allows for a greater breadth of data to be obtained, resulting in a more representative data set and smoothing any potential outliers.
Regarding claim 15, Joseph in view of Pearson, Goto, Sheehan, and Selzer teach the image-free ultrasound system as claimed in claim 14, and Joseph further teaches that a module 1 (sensor 102, [0040]) simultaneously generates local stiffness indices (local pulse wave velocity (PWV), [0040] & local PTT, [0075]) and regional stiffness indices (PTT, [0151]).
However, Joseph in view of Pearson fail to disclose that the module 1 simultaneously generates measures of endothelial function and stiffness indices.
Sheehan teaches that the module 1 (software, [0033]) simultaneously generates measures of endothelial function (endothelial function, [0043]) and stiffness indices (peak systolic velocity & end-diastolic velocity, [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 system taught by Joseph, Pearson, and Goto such that the module 1 simultaneously generates measures of endothelial function and stiffness indices, as taught by Sheehan. Assessments of endothelial function and arterial stiffness can both be used to diagnose cardiovascular disease; therefore, obtaining measurements of both simultaneously can result in a more accurate diagnosis.
However, Joseph in view of Pearson, Goto, and Sheehan fail to disclose that the module 1 generates stiffness indices over continuous cardiac cycles, wherein the module 1 generates values of individual cardiac cycles and their average.
Selzer teaches that the module 1 (computer processing system 48, [0062]) generates stiffness indices over continuous cardiac cycles ([0081]), wherein the module 1 generates values of individual cardiac cycles and their average ([0081]).
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 system system taught by Joseph, Pearson, Goto, and Sheehan such that the module 1 generates stiffness indices over continuous cardiac cycles, wherein the module 1 generates values of individual cardiac cycles and their average, as taught by Selzer. Obtaining data from multiple cardiac cycles produces a more accurate and representative data set to be analyzed.
Conclusion
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/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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