DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment to the claims filed 30 March 2026 has been entered. Claims 1, 7-9 and 45-46 are currently amended. Claim(s) 2-6, 15 and 18-44 were previously canceled. Claims 1, 7-14, 16-17 and 45-46 remain pending.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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.
Claim(s) 1 and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/101855 A1 (previously cited, Hilgers) in view of US 2004/0133092 A1 (Kain).
Regarding claim 1, Hilgers discloses and/or suggests a system for determining pulse wave velocity (PWV) of a blood vessel (e.g., Fig. 5), comprising:
a first implantable vascular sensor (sensor 18) configured to be implanted within the vessel (e.g., pg. 4, lines 11-12) at a first position, x1 (e.g., Fig. 5), the first vascular sensor configured to generate a first cardiac cycle waveform/signal, m1, of the vessel at the first position (pg. 13, lines 22-28, natural pulse wave generates a first signal at sensor 18; pg. 4, lines 26-29, sensor senses the pulse and provides a sensor signal based on the pulse; etc.);
a second implantable vascular sensor (sensor '18) configured to be implanted within the vessel (e.g., pg. 4, lines 11-12) at a second position, x2 (e.g., Fig. 5), the second vascular waveform sensor configured to generate a second cardiac cycle waveform/signal, m2, of the vessel at the second position (pg. 13, lines 22-28, natural pulse wave generates a second signal at sensor 18'; pg. 4, lines 26-29, sensor senses the pulse and provides a sensor signal based on the pulse; etc.); and
a processor (throughout document, controller, e.g., pg. 15, lines 25-29) configured to: receive the sensor signals; detect a first characteristic feature of the first cardiac cycle waveform and a second characteristic feature of the second cardiac cycle waveform; and determine the PWV of the vessel based on a time between the detected first and second characteristic features of the cardiac cycle waveform obtained by the first and second vascular waveform sensors, and a distance between the first and second positions of the first and second vascular sensors (pg. 13, lines 22-28, determining velocity of a pulse wave naturally initiated by the heart; pg. 5, lines 22-30, controller is capable of receiving the sensor signal and of analyzing the sensor signal to determine a PWV; pg. 2, lines 17-27, pg. 9, lines 2-10, etc., PWV is calculated based on the time interval between the onset of the pulse wave upstroke at each sensor and the pulse wave travel distance between the recording points; etc.).
While Hilgers discloses each of the first and seconds sensors may be implanted within the vessel, as noted above, and further discloses the sensors may measure mechanical deflection as the cardiac cycle waveforms (e.g., pg. 11, lines 5-7), Hilgers neither expressly discloses each of the first and second sensors engage an inner surface of the vessel at their respective positions, nor are area sensors that generate respective cardiac cycle area waveforms. Hilgers further does not expressly disclose each of the first and second sensors produce a wireless signal that is received by the processor. However, Hilgers does disclose the processor is preferably remote from the implanted device to reduce the size of the implanted device(s), wherein the sensor transmits a signal to the processor for analysis and providing results to a user (e.g., pg. 5, lines 27-28).
Kain discloses an implantable vascular area sensor (e.g., Fig. 1, implantable sensor 1B; Fig. 9; transducer 108; Fig. 13, sensor/unit 159, 160; etc.) configured to be implanted within the vessel engaging an inner surface of the vessel at a position (e.g., ¶ [0071]), the vascular area sensor configured to generate a cardiac cycle area waveform for the vessel at the position and to produce a wireless signal representing the cardiac cycle area waveform (e.g., ¶ [0069] when the blood vessel distends, the overall resonance frequency shifts and energy is re-radiated as return signal 21; ¶ [0073] change in frequency of sensor 159, 160 is related to the change in radius/distension of the blood vessel, e.g., Fig. 14; etc.). Kain further discloses the above-noted sensor is completely passive, and would therefore be preferrable for sensors implanted within a blood vessel due to miniaturization and power constraints (e.g., ¶ [0071]). Lastly, Kain, comparable to the disclosure of Hilgers, similarly discloses at least one fiducial point on said cardiac cycle area waveform may be identified for use in determining pulse wave velocity (e.g., Fig. 14; ¶ [0073]; etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Hilgers with the first implantable vascular sensor comprising a first implantable vascular area sensor configured to be implanted within the vessel engaging an inner surface of the vessel at the first position, the second implantable vascular sensor comprising a second implantable vascular area sensor configured to be implanted within the vessel engaging an inner surface of the vessel at the second position, wherein each of the first and second implantable vascular area sensors are configured to generate respective first and second cardiac cycle area waveforms and produce a wireless signal representing the respective first and second cardiac cycle area waveforms as taught/suggested by Kain in order to facilitate reducing the size, or space required by, the implanted components of the system and/or as a simple substitution of one suitable type of sensors for measuring respective cardiac cycle area waveforms for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claim 45, Hilgers discloses and/or suggests a system for determining pulse wave velocity (PWV) of a blood vessel (e.g., Fig. 5), comprising:
a first vascular sensor (sensor 18) configured to be implanted within the vessel (e.g., pg. 4, lines 11-12) at a first position, x1 (e.g., Fig. 5), the first vascular sensor configured to generate a first cardiac cycle waveform/signal, m1, of the vessel at the first position (pg. 13, lines 22-28, natural pulse wave generates a first signal at sensor 18; pg. 4, lines 26-29, sensor senses the pulse and provides a sensor signal based on the pulse; etc.);
a second vascular sensor (sensor '18) configured to be implanted within the vessel (e.g., pg. 4, lines 11-12) at a second position, x2 (e.g., Fig. 5), the second vascular waveform sensor configured to generate a second cardiac cycle waveform/signal, m2, of the vessel at the second position (pg. 13, lines 22-28, natural pulse wave generates a second signal at sensor 18'; pg. 4, lines 26-29, sensor senses the pulse and provides a sensor signal based on the pulse; etc.); and
a processor (throughout document, controller, e.g., pg. 15, lines 25-29) configured to: detect a first characteristic feature of the first cardiac cycle waveform and a second characteristic feature of the second cardiac cycle waveform; and determine the PWV of the vessel based on a time between the detected first and second characteristic features of the cardiac cycle waveform obtained by the first and second vascular waveform sensors, and a distance between the first and second positions of the first and second vascular sensors (pg. 13, lines 22-28, determining velocity of a pulse wave naturally initiated by the heart; pg. 5, lines 22-30, controller is capable of receiving the sensor signal and of analyzing the sensor signal to determine a PWV; pg. 2, lines 17-27, pg. 9, lines 2-10, etc., PWV is calculated based on the time interval between the onset of the pulse wave upstroke at each sensor and the pulse wave travel distance between the recording points; etc.).
While Hilgers discloses each of the first and seconds sensors may be implanted within the vessel, as noted above, and further discloses the sensors may measure mechanical deflection as the cardiac cycle waveforms (e.g., pg. 11, lines 5-7), Hilgers neither expressly discloses each of the first and second sensors engage an inner surface of the vessel at their respective positions, nor are area sensors that generate respective cardiac cycle area waveforms corresponding to a resonant frequency of the respective sensor when energized by an externally applied electric field. However, Hilgers does disclose the processor is preferably remote from the implanted device to reduce the size of the implanted device(s), wherein the sensor transmits a signal to the processor for analysis and providing results to a user (e.g., pg. 5, lines 27-28).
Kain discloses an resonant circuit-based vascular area sensor (e.g., Fig. 1, implantable sensor 1B; Fig. 9; transducer 108; Fig. 13, sensor/unit 159, 160; etc.) configured to be implanted within the vessel engaging an inner surface of the vessel at a position (e.g., ¶ [0071]), the vascular area sensor configured to generate a cardiac cycle area waveform for the vessel at the position corresponding to a resonant frequency of said sensor when energized by an externally applied electric field (e.g., ¶ [0069] when the blood vessel distends, the overall resonance frequency shifts and energy from signal 20 is re-radiated as return signal 21; ¶ [0073] change in frequency of sensor 159, 160 is related to the change in radius/distension of the blood vessel, e.g., Fig. 14; etc.). Kain further discloses the above-noted sensor is completely passive, and would therefore be preferrable for sensors implanted within a blood vessel due to miniaturization and power constraints (e.g., ¶ [0071]). Lastly, Kain, comparable to the disclosure of Hilgers, similarly discloses at least one fiducial point on said cardiac cycle area waveform may be identified for use in determining pulse wave velocity (e.g., Fig. 14; ¶ [0073]; etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Hilgers with the first vascular sensor comprising a first resonant circuit-based vascular area sensor configured to be implanted within the vessel engaging an inner surface of the vessel at the first position, the second vascular sensor comprising a second resonant circuit-based vascular area sensor configured to be implanted within the vessel engaging an inner surface of the vessel at the second position, wherein each of the first and second resonant circuit-based vascular area sensors are configured to generate respective first and second cardiac cycle area waveforms corresponding to a resonant frequency of the respective sensor when energized by an externally applied electric field, as taught/suggested by Kain in order to facilitate reducing the size, or space required by, the implanted components of the system and/or as a simple substitution of one suitable type of sensors for measuring respective cardiac cycle area waveforms for another to yield no more than predictable results. See MPEP 2143(I)(B).
Claim(s) 7-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hilgers in view of Kain as applied to claim(s) 1 above; or alternatively, over Hilgers in view of Kain as applied to claim(s) 1 above, and further in view of US 2018/0055386 A1 (previously cited, Zielenski).
Regarding claim 7, Hilgers as modified discloses/suggests the limitations of claim 1, and further discloses/suggests the first and second characteristic features are the onset of the pulse wave upstroke, or foot, of the respective cardiac cycle waveform measurements (e.g., pg. 2, lines 17-27; pg. 9, lines 2-10; etc.). Accordingly, Hilgers as modified does not expressly disclose the characteristic feature of the cardiac cycle waveform measurement is a peak, slope or a trough in the waveform. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system of Hilgers with the characteristic feature of the respective cardiac cycle waveform measurement is a peak, slope or a trough in the waveform because Applicant has not disclosed that any particular characteristic feature, including the particular features recited, provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant expressly discloses any readily recognizable features of the waveforms may be utilized (e.g., ¶ [0034]). Accordingly, as no evidence has been provided to the contrary, one of ordinary skill in the art, furthermore, would have expected Applicant's invention to perform equally well with the characteristic feature disclosed by Hilgers (e.g., onset of upstroke, foot, etc.) because either arrangement enables measuring pulse transit time, pulse wave velocity, and/or parameters determined therefrom.
Alternatively/Additionally, Zielenski discloses a comparable system configured to identify first and second characteristic features of a first cardiac cycle waveform measurement and a second cardiac cycle waveform measurement, respectively, wherein the first and second characteristic features is a peak (e.g., ¶ [0003] a fiducial point such as, e.g., a maximum peak value, etc., may be selected for each signal, and the time between the fiducial points in the signals may be determined, which is a pulse transit time). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Hilgers with the characteristic feature of the respective cardiac cycle waveform measurement being a peak as taught and/or suggested by Zielenski as a simple substitution of one suitable characteristic feature for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claims 8-11, Hilgers as modified discloses and/or suggests the processor is configured to determine a time of the first characteristic feature of the first cardiac cycle area waveform, t1, and a time of the second characteristic feature of the second cardiac cycle are waveform, t2; determine a time difference between the time of said first and second characteristic features of the first cardiac cycle area waveform and the second cardiac cycle area waveform using the equation Δt = t2 - t1, wherein the distance between the two sensors is determined by the equation Δx = x2 - x1; and determine the PWV using the equation PWV = Δx/Δt (pg. 2, lines 17-27; pg. 7, lines 22-23, a known distance can be chosen between the actuator and sensor; pg. 9, lines 2-10; etc.).
Regarding claim 12, Hilgers as modified discloses/suggests the processor configured to determine compliance (pg. 5, lines 22-25 determining an indication of vessel wall stiffness; pg. 8, lines 18-21, compliance is an indication of vessel stiffness). Hilgers as modified further discloses the claimed equation relating PWV and compliance C (pg. 9, first equation, which given C = ΔV/ΔP (pg. 8), can be rearranged to the claimed equation, comparable to Applicant's Equations (ii)-(iv), in ¶ [0039] of the specification as filed), such that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Hilgers with determining compliance, C, of the vessel using the determined PWV and said equation in order to facilitate using known functions/relationships to derive an indication of vessel stiffness.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hilgers in view of Kain (or Hilgers in view of Kain and Zielenski) as applied to claim(s) 12 above, and further in view of "Simple and Accurate Way for Estimating Total and Segmental Arterial Compliance: The Pulse Pressure Method" (previously cited, Stergiopulos).
Regarding claims 13-14, Hilgers as modified discloses/suggests the limitations of claim 12, as discussed above. Hilgers as modified further discloses/suggests the processor is configured to determine the pressure in the vessel (throughout document, e.g., pg. 1, lines 6-7), but does not expressly disclose a particular equation/relationship relating PWV and blood pressure, only disclosing it is known that PWV is a predictor of blood pressure (pg. 7, lines 13-16), and the Moens-Korteweg equation is often applied (pg. 2, lines 24-27). Accordingly, Hilgers as modified does not expressly disclose the processor is configured to determine the pressure in the vessel using the determined PWV and determined compliance using the equation as claimed.
Stergiopulos discloses the compliance-pressure equation of Applicant's claim 14 relating pressure in a vessel and compliance (pg. 393, Equation (1), which when rearranged to solve for "P" is equivalent to the equation of claim 14, including the constants Pa, Pb, a and b thereof), from which, given a determined compliance, pressure in a vessel can further be determined.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Hilgers with the processor being configured to determine pressure in the vessel using the determined compliance and the equation of claim 14 in order to utilize known relationships between PWV, compliance and pressure in a vessel to facilitate using existing sensors and hardware of the system to provide additional cardiovascular parameters, such as pressure, which may be particularly important for high risk patients (Hilgers, pg. 2, lines 27-30).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hilgers in view of Kain (or Hilgers in view of Kain and Zielenski) as applied to claim(s) 1 above, and further in view of US 2019/0183354 A1 (previously cited, Rowe).
Regarding claim 16, Hilgers as modified discloses/suggests the limitations of claim 1, but does not expressly disclose the blood vessel is one of the jugular or brachiocephalic vein, the superior vena cava or the inferior vena cava, IVC. However, Hilgers does disclose the system can be used to monitor blood pressure in the vessel (throughout document, e.g., pg. 1, lines 6-7).
Rowe discloses a system configured to be implanted in the IVC, said system configured for monitoring IVC blood pressure (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Hilgers with the blood vessel being the IVC as taught and/or suggested by Rowe in order to facilitate using the system for diagnosing acute decompensated heart failure (Rowe, Abstract).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hilgers.
Regarding claim 17, Hilgers discloses/suggests a method for determining PWV of a blood vessel in a patient, the method comprising:
detecting a cardiac cycle waveform of the vessel with a first sensor implanted within the blood vessel at a first position, x1, along the vessel (Fig. 5, body insertable device including sensor 18; pg. 4, lines 11-12, a body insertable device can be attached to a vessel or implanted in a vessel) and producing a first signal representing the cardiac cycle waveform at the first position with the first sensor (pg. 13, lines 22-28, natural pulse wave generates a first signal at sensor 18; pg. 4, lines 26-29, sensor senses the pulse and provides a sensor signal based on the pulse; etc.);
detecting the cardiac cycle waveform of the vessel with a second sensor implanted within the blood vessel at a second position, x2, along the vessel (Fig. 5, body insertable device including sensor 18'; pg. 4, lines 11-12, a body insertable device can be attached to a vessel or implanted in a vessel) and producing a second signal representing the cardiac cycle waveform at the second position with the second sensor (pg. 13, lines 22-28, natural pulse wave generates a second signal at sensor 18'; pg. 4, lines 26-29, sensor senses the pulse and provides a sensor signal based on the pulse; etc.), wherein the second position is at a known distance from the first position (e.g., pg. 7, lines 22-23, a known distance can be chosen between the actuator and sensor);
receiving the first and second signals (pg. 5, lines 22-30, controller receiving the sensor signals);
identifying from said signals at least one characteristic feature of the cardiac cycle waveform and determining a time of travel of the at least one characteristic feature of the waveform from the first position to the second position (pg. 2, lines 17-27, pg. 9, lines 2-10, etc., time interval between the onset of the pulse wave upstroke at each sensor); and
determining the PWV of the vessel based on the known distance and the determined time of travel of the at least one characteristic feature of the cardia cycle waveform (pg. 2, lines 17-27, pg. 9, lines 2-10, etc., PWV is calculated based on the time interval between the onset of the pulse wave upstroke at each sensor and the pulse wave travel distance between the recording points).
Hilgers does not expressly disclose each of the first and second sensors of the embodiment illustrated in Figure 5 produce a wireless signal, or the wireless signals are received outside the patient's body. However, Hilgers discloses alternative embodiments comprising two spatially separated body insertable devices, each having their own control circuitry (e.g., Fig. 4; pg. 13, lines 11-17; etc.). Hilgers further discloses the controller that receives the sensor signals may include at least one component that is part of and/or implanted with the implantable device(s), such as control circuitry, and at least one component that is external to the body, such as a processor for processing the signals (pg. 9, line 27 - pg. 10, line 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method (e.g., embodiment of Figure 5) of Hilgers with a first sensor (e.g., a first body insertable device including sensor 18) producing a first wireless signal representing the first cardiac cycle waveform measurement, and a second sensor (e.g., a second body insertable device including sensor 18') producing a second wireless signal representing the second cardiac cycle waveform measurement; and the controller (or at least a component thereof) receiving said wireless signals outside the patient's body in order to reduce the size of the implantable sensors, reduce the impact of the implantable sensors on parameters derived from PWV, enabling larger distances to be covered, etc. (pg. 5, lines 26-30; pg. 13, lines 11-17; etc.).
Claim(s) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hilgers in view of Kain as applied to claim(s) 45 above; or alternatively, over Hilgers in view of Kain as applied to claim(s) 45 above, and further in view of US 2014/0187977 A1 (previously cited, Lading '977).
Regarding claim 46, Hilgers as modified discloses/suggests each sensor includes a variable inductance and a capacitance configured to produce the resonant frequency correlated to a physical dimension of the blood vessel in which said sensors are implanted (e.g., Kain, claim 13).
Alternatively/Additionally, Lading '977 discloses/suggests a sensor comprising a resonant circuit-based sensor (e.g., ¶ [0009] sensor comprises electronic circuitry in a housing adapted to sense geometric variations of the housing and provide an electronic parameter variation in response to the geometric variation; ¶ [0012] electronic circuit is a resonant circuit comprising an inductor and a capacitor) positionable proximate a blood vessel (e.g., ¶ [0006] housing adapted to be attached to the body of a living being proximate to an artery; Fig. 1; etc.), wherein the sensor includes a variable inductance and a capacitance configured to produce a resonant frequency correlated to a physical dimension of the blood vessel to which said sensor is proximate (¶¶ [0037]-[0039] the capacitor and the inductor are interconnected to form a resonant circuit, wherein the value of one of the capacitor and inductor is fixed, while the other varies with the diameter of the vessel (see, e.g., ¶¶ [0013]-[0014]) resulting in a resonant frequency that varies as a function of the variable parameter).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Hilgers with the sensors including a variable inductance and a capacitance configured to produce a resonant frequency correlated to a physical dimension of the blood vessel in which said sensors are implanted as taught/suggested by Lading '977 as a simple substitution of one suitable passive sensor type for measuring cardiac cycle area waveforms (e.g., variable inductance, fixed capacitance) for another (e.g., variable capacitance, fixed inductance) to yield no more than predictable results. See MPEP 2143(I)(B).
Response to Arguments
Applicant's arguments with respect to the newly-added limitations of claims 1 and 45 have been considered but are moot because the new ground(s) 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.
Applicant's remaining arguments have been fully considered but they are not persuasive.
With respect to claim 17, Applicant contends, "The rejection therefore relies on a proposed modification of Hilgers, asserting that it would have been obvious to modify the method so that a first sensor produces a first wireless signal representing the first cardiac cycle waveform measurement, a second sensor produces a second wireless signal representing the second cardiac cycle waveform measurement, and the controller, or a component thereof, receives those wireless signals outside the patient's body. […] That reasoning is insufficient" (Remarks, pgs. 8-9).
It is unclear to what "reasoning" Applicant is referring, as the prior paragraph does not address the reasoning utilized in the rejection of record. Rather, Applicant merely reproduces what the proposed modification(s) to Hilgers is, not why it/they were proposed.
Applicant further contends, "Hilgers is based on a controller-centered arrangement in which the controller receives the sensor signals and performs the analysis. The rejection does not adequately explain why one of ordinary skill in the art would have altered that arrangement to arrive at the claimed method, in which the first and second sensors themselves produce wireless signals representing the respective cardiac cycle waveforms and those wireless signals are received outside the patient's body for the subsequent feature identification and pulse-wave-velocity determination steps recited in claim 17" (Remarks, pg. 8).
The examiner respectfully disagrees. The proposed modification(s) are still, in Applicant's words, "controller-centered." The proposed modification(s) merely address where the controller (or components thereof) is located, and how the sensors communicate with said controller or components thereof. Hilgers discloses a processor of the controller, which is the component used to receive and process/analyze sensor signals, may be located external to the insertable device (see, e.g., pg. 9, line 29 - pg. 10, line 3) and that a sensor may transmit its signals to the remote controller for analysis (e.g., pg. 5, lines 27-30). Hilgers merely does not expressly disclose each sensor produces a wireless signal to be received outside the patient's body. The proposed modification of Hilgers is that each sensor wirelessly transmits its data to an externally-located processor (i.e., an analysis section of the controller, i.e., the processor, is located outside the body and in wireless communication with each sensor). The proposed modification is consistent with the disclosure of Hilgers and enables, inter alia, reducing the size of the implantable portion of the system, which Hilgers expressly discloses is desirable (e.g., pg. 5, lines 27-30).
Applicant submits, "The rejection does not identify a teaching in Hilgers that would have led one of ordinary skill to use two implanted sensors as separate wireless waveform sources for receipt outside the body, rather than using the controller-based signal handling and analysis arrangement otherwise attributed to Hilgers" (Remarks, pg. 9).
As noted above, these are not mutually exclusive arrangements. The proposed modification merely requires part of the controller (i.e., the analysis portion thereof, or processor) to be located external to the body, with each sensor transmitting its signal thereto, which is consistent with the teachings of Hilgers.
Applicant further submits, "Separate body-insertable devices are not the same as the claimed method, which requires that each implanted sensor produce a wireless signal representing the cardiac cycle waveform and that those wireless signals be received outside the patient's body. The rejection does not sufficiently explain why the cited alternative embodiment would have suggested that specific signal-flow architecture" (Remarks, pgs. 9).
The examiner has made no contention that separate body-insertable devices are "the same as the claimed method." Rather, the Office action acknowledges Hilgers discloses at least one embodiment in which two sensors are provided along the length of the vessel, and at least one embodiment in which two separate devices are provided along the length of the blood vessel. Since the sensors may be physically separate (e.g., not provided on a common substrate), one of ordinary skill in the art would readily appreciate that providing each sensor in such an arrangement with the ability to transmit its data to a remotely-located processor eliminates the need for any physical connection between the two devices (e.g., each electrically connected to a shared transmitter or transceiver), which may be particularly useful when large distances are desired to be covered.
With respect to claim 7, Applicant contends, "The rejection asserts that use of a peak, slope, or trough would have been an obvious matter of 'design choice,' and alternatively cites Zielinski for a peak. Office Action, § 8. That reasoning is insufficient on the present record. Hilgers is relied on for a specific timing feature, namely the onset or foot of the pulse wave, and the Office Action does not adequately explain why one of ordinary skill in the art would have replaced that expressly relied-upon feature with the claimed peak, slope, or trough in the particular claimed system. Nor does the alternative reliance on Zielinski establish obviousness of the full claimed set of alternatives, since Zielinski is cited only for a peak, not for a slope or trough. Accordingly, Applicant respectfully submits that claim 7 is separately patentable" (Remarks, pg. 10).
The examiner respectfully disagrees. Applicant's remarks fail to address why using one of a peak, slope or trough of the waveform is any more of a mere matter of design choice when Applicant expressly discloses "any characteristic feature can be selected" (¶ [0034]). Further, as Applicant acknowledges, the claim recites alternatives, such that use of any one feature is required to meet the limitations of claim 7. Zielinski discloses at least the peak/maximum is one exemplary fiducial point that may alternatively/additionally be used to calculate a pulse transit time. However, for the sake of completeness, the examiner notes that Zielinski does further disclose a slope (Fig. 7, point (D)) or a trough (Fig. 7, point (A)) are additional exemplary fiducial points that may be used in a PTT calculation.
With respect to claim 12, Applicant submits, "The rejection depends on reconstructing the claimed compliance determination from separate concepts in Hilgers after the fact, rather than identifying a disclosure or reasoned suggestion in Hilgers to determine compliance C from PWV using the claimed relationship. A generalized discussion of vessel wall stiffness does not adequately establish the specific compliance calculation required by claim 12" (Remarks, pg. 10-11).
The examiner respectfully disagrees. Hilgers expressly discloses the controller may provide an indication of vessel wall stiffness (pg. 5, lines 23-24), which may be determined based on PTT/PWV (pg. 9, lines 11-12), and discloses compliance is a parameter that describes vessel stiffness (pg. 8, lines 19-20). Hilgers does not disclose any specific equation for arterial stiffness generally, or compliance specifically, such that one of ordinary skill in the art would readily appreciate Hilgers discloses/suggests calculating an indication of vessel wall stiffness, such as compliance, based on the known, disclosed relationships, which includes the claimed relationship (e.g., pg. 8, lines 18 - pg. 9, line 1).
With respect to claim 13, Applicant submits, "The rejection does not identify an express teaching in Hilgers of using those two determined values together to determine vessel pressure. Rather, the reasoning appears to reconstruct the claimed approach from generalized statements about pressure and PWV. On this record, that does not adequately establish a teaching or suggestion of the specific pressure-determination methodology required by claim 13. Accordingly, Applicant respectfully submits that claim 13 is separately patentable" (Remarks, pg. 11). With respect to claim 14, Applicant submits, "[The] rejection relies on Stergiopulos for a compliance-pressure equation and states that, when rearranged, it is equivalent to the claimed equation. Office Action, § 9. The statement of the rejection, however, does not establish why one of ordinary skill in the art would have selected and incorporated that particular rearranged compliance-pressure equation, with the claimed constants and reference-compliance framework, into the Hilgers system. The rejection provides a broad and non-specific rationale of using known relationships to derive additional cardiovascular parameters, but does not sufficiently explain why the specific claimed equation of claim 14, as opposed to other possible pressure-estimation approaches, would have been chosen" (Remarks, pgs. 11-12).
The examiner respectfully disagrees, and notes the rejection of claim 13 does not rely on Hilgers alone, but rather explicitly acknowledges Hilgers only discloses PWV is a predictor of blood pressure (pg. 7, lines 13-16), and the Moens-Korteweg equation is often applied (pg. 2, lines 24-27). Stergiopulos is relied on as disclosing a function relating PWV, compliance and pressure, that would be suitable for calculating pressure given a known/determined compliance and PWV, and therefore would have been an obvious, suitable means/method by which the calculate blood pressure using the system of Hilgers. It is unclear how Applicant's statement that the rejection of record "does not sufficiently explain why the specific claimed equation of claim 14, as opposed to other possible pressure-estimation approaches, would have been chosen" is indicative of non-obviousness. That multiple pressure-estimation methods may be obvious and/or suitable does not necessarily indicate any particular one of said methods is non-obvious.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. Applicant is encouraged to use the USPTO Automated Interview Request at http://www.uspto.gov/interviewpractice to schedule an interview.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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