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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 31 March 2026 has been entered.
Status of Claims
Claim(s) 1, 6, 8-10, 12, 14-15, 18-19 and 21 is/are currently amended. Claim(s) 2-3, 11, 16-17 and 23 has/have been canceled. New claim(s) 24-26 has/have been added. Claim(s) 1, 4-10, 12-15, 18-22 and 24-26 is/are pending.
Objections and/or Rejections Withdrawn
Objections to the claims and/or rejections under 35 U.S.C. 112(b) (or pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1, 4-10, 12-15, 18-22 and 26 is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, claim 14, claim 26 and claims dependent thereon, the only mention of "wall tension" in the specification as filed states, "The FPS device 10 measures the vessel wall tension through the entire pressure waveform so blood pressure, flow phases, and heart rate can be measured simultaneously without contacting blood or interfering with a patient's normal activities" (¶ [0063]). The specification also refers to "tension" generally, stating, "As used herein, the term 'strain sensor' can refer to a sensor whose resistance varies with applied force. The strain sensor can convert force, pressure, tension, weight, etc., into a change in electrical resistance, which can then be measured. The term 'pressure sensor' can be used herein interchangeably with 'strain sensor' with pressure being but one factor that can change the electrical resistance" (¶ [0032]). The examiner is unable to locate any further disclosure with respect to "tension" and/or "wall tension."
In above-noted paragraph [0063], Applicant appears to disclose wall tension throughout the entire pressure waveform is measured or measurable by the FPS device "so blood pressure, flow phases, and heart rate can be measured simultaneously." This paragraph, at best, appears to indicate that the sensor output, which varies as wall tension varies throughout a pulse, can be used to determine a measure of "blood pressure, flow phases, and heart rate." In above-noted paragraph [0032], Applicant appears to disclose that any force applied to the disclosed sensor, including tension, results in a measurable change in electrical resistance of said sensor. This paragraph does not describe/disclose how to differentiate measures of each force (pressure, tension, etc.) from the sensor output. Accordingly, said paragraph does not disclose analyzing or processing the output of the sensor derive a "measure of wall tension." Accordingly, while Applicant generally discloses changes in tension in the wall around which the sensor is positioned affects the electrical resistance of said sensor, Applicant fails to disclose determining a measure of wall tension of a vessel or graft based on the electrical resistance data.
Even assuming arguendo that such a feature is broadly disclosed, which the examiner does not concede for the reasons noted above, Applicant fails to sufficiently disclose an algorithm for deriving a "measure of wall tension" from the electrical resistance data. As apparently acknowledged by Applicant (e.g., Remarks, pgs. 10-11), wall tension is/may be a result of various factors, including pressure within a vessel or graft. Applicant fails to sufficiently describe how the sensor output is/may be used to provide a measure of wall tension, and/or how the effects of any singular, particular force acting on the sensor, including wall tension, may be isolated from the sensor output.
Additionally, Applicant discloses, "In some instances, the sensor interface 24 can include a bridge circuit that is on the flexible circuit board 22 to measure the displacement of the FPS caused by the pressure of and/or within the measurement target. In some instances, the sensor interface 24 can perform additional data processing tasks on the data received from the FPS 12 and/or the data determined by another sensor mounted on the circuit board, e.g. a pressure sensor. The sensor interface 26 can send the processed data to the wireless transmitter 26" (¶ [0050]). There is no indication that the "additional processing tasks" performed by the sensor interface include and/or encompass processing sensor output to determine a measure of any particular force acting on the sensor, including wall tension, or that the wireless transmitter transmits such a measure. To the contrary, in the subsequent paragraphs (e.g., ¶¶ [0052]-[0054]), the "additional processing" is disclosed/described as signal conditioning tasks, i.e., amplification, filtering and/or analog-to-digital conversion.
In view of the above, the limitations "a flexible circuit board bonded and electrically connected to the FPS, the flexible circuit board comprising: […] a microcontroller configured to determine a measure of wall tension of the vessel or the graft based on the electrical resistance data over the entire hemodynamic waveform; and a wireless transmitter on the flexible circuit board configured to transmit the electrical resistance data and the measure of the wall tension wirelessly to an external device" of claim 1, and the comparable limitations of claims 14 and 26 lack sufficient support in the application as filed and therefore are directed to and/or encompass new matter.
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, 4-5, 7-8, 10 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0110747 A1 (previously cited, "Majerus") in view of US 2011/0066046 A1 (previously cited, "Young") and US 2020/0345246 A1 ("Hilgers").
Regarding claims 1 and 4-5, Majerus discloses/suggests an apparatus comprising:
a flexible pulsation sensor (FPS) (sensor apparatus 10, 52, 100) configured to wrap around a vessel or graft (¶ [0022]; ¶ [0034]; ¶ [0065]; Fig. 3; etc.) without impeding fluid flow through the vessel/graft (e.g., ¶ [0034]), wherein the FPS comprises a piezoresistive elastomer composite comprising conductive nanoparticles dispersed within a PDMS elastomer (¶ [0033] conductive layer comprises a piezoresistive elastomer, such as a conductive PDMS, e.g., ¶ [0023] conductive layer 12 may be formed by dispersing electrically conductive materials in a viscous polymer matrix, such as carbon nanoparticles/nanotubes or graphene flakes dispersed in PDMS), wherein the FPS is configured to measure electrical resistance data that is a function of a displacement of the piezoresistive elastomer composite of the FPS responsive to changes in circumferential strain of the vessel or the graft from pulsatile fluid flow through the vessel or the graft over an entire hemodynamic waveform (¶ [0036] circuitry 92 of system 50 is configured to measure the electrical resistance in response to application of an AC signal (e.g., pulses) over time, wherein the electrical resistance of conductive layer 62 varies as a function of its length, corresponding to circumferential strain of the graft 54 and sensor apparatus (e.g., operating as a strain gauge), e.g., Fig. 7, Fig. 8B, Fig. 9, etc.);
a sensor interface configured to collect at least the electrical resistance data (measurement circuitry 92; ¶ [0036] electrical resistance of the sensor apparatus 52 may be determined to provide measurement data, e.g., ¶¶ [0043]-[0044]);
a microcontroller configured to determine a measure based on the electrical resistance data over the entire hemodynamic waveform (¶ [0036] processor implementing additional processing of the electrical resistance to provide processed measurement data, such as graft wall motion, pressure and/or flow through the site where the sensor apparatus 52 is mounted); and
a wireless transmitter configured to transmit the measure(s) to an external device (wireless communication interface 94; ¶ [0037] communicating measurement data to a remote location; etc.),
wherein the external device is configured to receive the measure(s) to perform diagnostics (e.g., ¶ [0038] remote device may be configured to a monitor (e.g., wall motion), or trend therein, based on the measurement data).
Majerus does not disclose the apparatus comprises a flexible circuit board bonded and electrically connected to the FPS, wherein the flexible circuit board comprises the sensor interface, the microcontroller and the wireless transmitter.
Young discloses an apparatus comprising a pulsation sensor device comprising a piezo-resistive element configured to detect displacement through an entire pressure waveform with fluid flow through a measurement target (¶ [0029] piezoresistive pressure sensor, or piezoresistive element thereof, configured to respond to expansion and contraction of said blood vessel); a flexible circuit board (substrate 22, which may comprise a flexible circuit board, e.g., ¶ [0029]) bonded and electrically connected the pulsation sensor (e.g., Figs. 1-3), the flexible circuit board comprising a sensor interface on the flexible circuit board configured to collect data related to displacement of the sensor (Fig. 2, ¶ [0029], chip 30 and/or components 36 mounted to substrate 22; e.g., ¶¶ [0050]-[0051] interface electronics 308); a microcontroller (IC chip 30 mounted to the substrate 22, or control unit 306 thereof); and a wireless transmitter on the flexible circuit board configured to wirelessly transmit data from the sensor interface to an external device (Fig. 2, ¶ [0029], chip 30 and/or components 36 mounted to substrate 22; e.g., ¶ [0051] transmitter 314 that wirelessly transmits the signal via an antenna 316).
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 apparatus of Majerus to comprise a flexible circuit board including the sensor interface, the microcontroller and the wireless transmitter thereon as taught and/or suggested by Young in order to facilitate providing a fully implantable monitoring device for effective in vivo real-time monitoring (Young, ¶ [0006]) for untethered or ambulatory subjects (Young, ¶ [0054]).
Majerus as modified does not expressly disclose the measure(s) include a measure of wall tension of the vessel/graft based on the electrical resistance data over the entire hemodynamic waveform.
Hilgers discloses/suggests an apparatus comprising an FPS configured to wrap around a vessel/graft (sensor 18; ¶ [0070]; ¶ [0077]; etc.); a microcontroller (controller 20) configured to determine a measure of wall tension of the vessel/graft based on electrical resistance data over the entire hemodynamic waveform (¶ [0034]; ¶ [0082]; etc.); and a wireless transmitter configured to transmit the electrical resistance data or the measure of the wall tension wirelessly to an external device (e.g., ¶ [0035]).
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 apparatus of Majerus with the measure(s) determined by the microcontroller including a measure of wall tension (e.g., stiffness, compliance, etc.) as taught and/or suggested by Hilgers in order to provide additional measurement data of the measurement site (i.e., vessel/graft) (Hilgers, ¶ [0082]), thereby facilitating a more comprehensive diagnostic assessment of the measurement site by the external device (e.g., plaque growth, stenosis, etc.) (Hilgers, ¶ [0078]).
Majerus as modified does not expressly disclose the wireless transmitter is configured to transmit the electrical resistance data and the measure(s) determined by the microcontroller. Rather, the cited prior art appears to disclose either electrical resistance data (sensor output) or measurement data (determined measure(s)) are transmitted by the wireless transmitter (e.g., Hilgers, ¶ [0035]). 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 apparatus of Majerus with the wireless transmitter being configured to transmit the electrical resistance data and the measure(s) determined by the microcontroller to the external device for diagnostics because Applicant has not disclosed that such a microcontroller provides an advantage, is used for a particular purpose, or solves a stated problem. Indeed, as noted above with respect to rejections under 35 U.S.C. 112(a), Applicant does not appear to even disclose such a feature. Therefore, as no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with Majerus as modified above (e.g., determined measure(s) being transmitted for diagnosis) because either arrangement permits monitoring of untethered or ambulatory subjects.
Regarding claims 7-8, Majerus as modified discloses/suggests the limitations of claim 1, as discussed above, but does not disclose the wireless transmitter comprises an analog to digital converter (ADC), or the microcontroller is integrated with the ADC.
Young discloses an apparatus as noted above, wherein the wireless transmitter comprises an ADC, and the microcontroller is integrated with the ADC (Fig. 7, where ADC 310 and wireless transmitter 314 are provided on an integrated circuit (IC) chip 30).
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 apparatus of Majerus with the wireless transmitter comprising an ADC, wherein the microcontroller is integrated with the ADC, as taught/suggested by Young in order to enable conditioning the sensor output for further processing and/or transmission, such as converting said output to a corresponding digital signal that can be analyzed and/or sent wirelessly to a data acquisition unit (Young, ¶ [0041]) and/or as a simple substitution of one suitable means and/or arrangement for wirelessly transmitting detected sensor and/or determined measurement data for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claim 10, Majerus as modified discloses/suggests the sensor interface comprises a bridge circuit on the flexible circuit board configured to measure a displacement of the FPS caused by the changes in circumferential strain of the vessel/graft (¶ [0043] measurement circuitry 92 of the measurement system may be implemented to include circuitry 200 of Fig. 6; ¶ [0049]; etc.).
Regarding claim 12, Majerus as modified discloses/suggests the vessel/graft comprises a vessel, an autograft, an allograft, a xenograft, or a synthetic graft (e.g., ¶ [0042] apparatus is positioned circumferentially around a cylindrical graft 152; ¶ [0065]; etc.).
Regarding claim 13, Majerus as modified teaches/suggests the apparatus is configured to measure at least one value indicative of a blood pressure and/or a heart rate of a patient (e.g., ¶ [0036] measured electrical resistance over time may be processed by the measurement system 90 (e.g., by a processor) to provide processed measurement data, such as representing graft wall motion, pressure and/or flow through the site where the sensor apparatus 52 is mounted).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Majerus in view of Young and Hilgers as applied to claim(s) above, and further in view of US 2007/0208232 A1 ("Kovacs").
Regarding claim 6, Majerus discloses/suggests the limitations of claim 1, as discussed above, but does not disclose/suggest the apparatus further comprises an amplifier on the flexible circuit board and configured to interface with the sensor interface and the wireless transmitter.
Young discloses the apparatus further comprises an amplifier on the flexible circuit board and configured to interface with the sensor interface and the wireless transmitter to amplify the data collected by the sensor interface for transmission by the wireless transmitter (¶ [0050] interface circuitry can be implemented to include conversion circuitry as described with respect to, e.g., Fig. 6; ¶ [0041] conversion circuity may include second gain stage 204, i.e., an amplifier, wherein the output of the second gain stage 204 can be converted to a corresponding digital signal that can be sent wirelessly to a data acquisition unit; 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 apparatus of Majerus with the flexible circuit board further comprising an amplifier configured to interface with the sensor interface and the wireless interface to amplify the sensor data before transmission of said data to the external device as taught and/or suggested by Young in order to facilitate conditioning the sensor output for transmission and further processing (Young, ¶ [0041]).
Majerus does not disclose the amplifier is configured to bandpass filter the electrical resistance data or amplify the electrical resistance data to fit within a full-scale voltage range. However, Young (or Majerus as modified thereby) discloses the output of the amplifier is provided to an ADC prior to transmission and/or the wireless transmitter comprises/is integrated with an ADC (e.g., ¶¶ [0050]-[0051]).
Kovacs discloses an apparatus comprising an analog sensor (¶ [0040]); and an amplifier (signal processing/conditioning circuit 52) configured to interface with the sensor to bandpass filter the sensor data (¶ [0048] filtering operations performed by filtering circuit 118 of circuit 52 include anti-aliasing, noise-rejection, and band-shaping) and amplify the electrical resistance data to fit within a full-scale voltage range (¶ [0047] amplification circuit 112 of circuit 52 amplifies received signals so that the amplitude of the signal output to ADC 58 corresponds generally to the full-scale input signal of ADC 58).
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 apparatus of Majerus with the amplifier being configured to bandpass filter the electrical resistance data and amplify the electrical resistance data to fit within a full-scale voltage range as taught/suggested by Kovacs in order to isolate frequencies of interest in the electrical resistance data, thereby reducing out-of-band noise, and to match the input range of the ADC, thereby maximizing system resolution (Kovacs, ¶¶ [0047]-[0048]).
Claim(s) 14 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Majerus in view of Hilgers.
Regarding claim 14, Majerus discloses/suggests a method comprising:
wrapping a flexible pulsation sensor (FPS) device (e.g., Fig. 3, sensor system 50) around a vessel or graft (¶ [0022]; ¶ [0034]; ¶ [0065]; Fig. 3; etc.), the FPS device comprising a piezoresistive elastomer composite comprising conductive nano-particles dispersed within a polydimethylsiloxane (PDMS) elastomer (¶ [0033] conductive layer comprises a piezoresistive elastomer, such as a conductive PDMS; ¶ [0023] conductive layer 12 may be formed by dispersing electrically conductive materials in a viscous polymer matrix, such as carbon nanoparticles or nanotubes or graphene flakes dispersed in PDMS);
detecting, by the FPS device, electrical resistance data that is a function of a displacement of the piezoresistive elastomer composite responsive to changes in circumferential strain of the vessel or the graft from pulsatile fluid flow through the vessel/graft over an entire hemodynamic waveform (¶ [0036] circuitry 92 of system 50 is configured to measure the electrical resistance in response to application of an AC signal (e.g., pulses) over time, wherein the electrical resistance of the conductive layer 62 varies as a function of its length, corresponding to circumferential strain of the graft 54 and sensor apparatus (e.g., operating as a strain gauge), e.g., Fig. 7, Fig. 8B, Fig. 9, etc.);
determining, by a microcontroller of the FPS device, a measure of the vessel/graft based on the electrical resistance data over the entire hemodynamic waveform (¶ [0036] processor implementing additional processing of the electrical resistance to provide processed measurement data, such as graft wall motion, pressure and/or flow through the site where the sensor apparatus 52 is mounted); and
sending, by a wireless transmitter of the FPS device, the measure(s) to an external device (wireless communication interface 94; ¶ [0037] communicating measurement data to a remote location; etc.), wherein the external device is configured to receive the measure(s) to perform diagnostics (e.g., ¶ [0038] remote device may be configured to a monitor (e.g., wall motion), or trend therein, based on the measurement data).
Majerus as modified does not expressly disclose the measure(s) include a measure of wall tension of the vessel/graft based on the electrical resistance data over the entire hemodynamic waveform.
Hilgers discloses/suggests an apparatus comprising an FPS configured to wrap around a vessel/graft (sensor 18; ¶ [0070]; ¶ [0077]; etc.); a microcontroller (controller 20) configured to determine a measure of wall tension of the vessel/graft based on electrical resistance data over the entire hemodynamic waveform (¶ [0034]; ¶ [0082]; etc.); and a wireless transmitter configured to transmit the electrical resistance data or the measure of the wall tension wirelessly to an external device (e.g., ¶ [0035]).
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 apparatus of Majerus with the measure(s) determined by the microcontroller including a measure of wall tension (e.g., stiffness, compliance, etc.) as taught and/or suggested by Hilgers in order to provide additional measurement data of the measurement site (i.e., vessel/graft) (Hilgers, ¶ [0082]), thereby facilitating a more comprehensive diagnostic assessment of the measurement site by the external device (e.g., plaque growth, stenosis, etc.) (Hilgers, ¶ [0078]).
Majerus as modified does not expressly disclose the method comprises sending the electrical resistance data and the measure(s) determined by the microcontroller to the external device. Rather, the cited prior art appears to disclose either electrical resistance data (sensor output) or measurement data (determined measure(s)) are transmitted by the wireless transmitter (e.g., Hilgers, ¶ [0035]). 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 method of Majerus with transmitting the electrical resistance data and the measure(s) determined by the microcontroller to the external device for diagnostics because Applicant has not disclosed that such a transmission(s) provides an advantage, is used for a particular purpose, or solves a stated problem. Indeed, as noted above with respect to rejections under 35 U.S.C. 112(a), Applicant does not appear to even disclose the claimed combination of features, let alone a benefit thereof. Therefore, as no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with Majerus as modified above (e.g., determined measure(s) being transmitted for diagnosis) because either arrangement permits comprehensive diagnostic assessment of the measurement site.
Regarding claim 18, Majerus discloses the vessel/graft comprises a vessel an autograft, an allograft, a xenograft, or a synthetic graft (¶ [0031] graft 54, which may be biological or synthetic tissue graft; ¶ [0065]; etc.).
Claim(s) 15 and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Majerus in view of Hilgers as applied to claim(s) 14 above, and further in view of Young.
Regarding claim 15, Majerus as modified discloses/suggests the limitations of claim 14, as discussed above, and further teaches/suggests the FPS device comprises:
an FPS having the piezoresistive composite elastomer, the FPS configured to wrap around the vessel/graft (sensor apparatus 52 mounted to circumscribe graft 54);
a pressure sensor configured to collect data the electrical resistance (¶ [0036] measurement circuitry 92 measuring electrical resistance of the sensor apparatus 52 as measurement data and/or a combination of measurement circuitry 92 and a processor of measurement system 90 configured to measure and process the electrical resistance to determine a parameter, e.g., pressure through the measurement target, as measurement data), wherein the wireless transmitter is configured to transmit the measure(s) wirelessly to the external device (¶ [0037] measurement system 90 of system 50 may also include a wireless interface to communicate measurement data to a remote location).
Majerus does not teach the FPS device comprises a flexible circuit board bonded and electrically connected to the FPS, wherein the pressure sensor and the wireless transmitter are on the flexible circuit board.
Young discloses an apparatus comprising a pulsation sensor device comprising a piezo-resistive element configured to detect displacement through an entire pressure waveform with fluid flow through a measurement target (¶ [0029] piezoresistive pressure sensor, or piezoresistive element thereof, configured to respond to expansion and contraction of said blood vessel); a flexible circuit board (substrate 22, which may comprise a flexible circuit board, e.g., ¶ [0029]) bonded and electrically connected the pulsation sensor (e.g., Figs. 1-3), the flexible circuit board comprising a sensor interface on the flexible circuit board configured to collect data related to displacement of the sensor (Fig. 2, ¶ [0029], chip 30 and/or components 36 mounted to substrate 22; e.g., ¶¶ [0050]-[0051] interface electronics 308); a microcontroller (IC chip 30 mounted to the substrate 22, or control unit 306 thereof); and a wireless transmitter on the flexible circuit board configured to wirelessly transmit data from the sensor interface to an external device (Fig. 2, ¶ [0029], chip 30 and/or components 36 mounted to substrate 22; e.g., ¶ [0051] transmitter 314 that wirelessly transmits the signal via an antenna 316).
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 FPS device of the method of Majerus to comprise a flexible circuit board including the sensor interface, the microcontroller and the wireless transmitter thereon as taught and/or suggested by Young in order to facilitate providing a fully implantable monitoring device for effective in vivo real-time monitoring (Young, ¶ [0006]) for untethered or ambulatory subjects (Young, ¶ [0054]).
Regarding claims 19-21, Majerus as modified discloses/suggests the limitations of claim 15, as discussed above, but does not disclose the method further comprises, amplifying, by an amplifier of the FPS device, the electrical resistance data after detection by the pressure sensor of the FPS device transmission by the wireless transmitter, or the wireless transmitter comprises an analog to digital converter (ADC).
Young discloses an apparatus comprising an amplifier configured to interface with a sensor and the wireless transmitter to amplify the data collected by the sensor interface for transmission by the wireless transmitter (¶ [0050] interface circuitry can be implemented to include conversion circuitry as described with respect to, e.g., Fig. 6; ¶ [0041] conversion circuity may include second gain stage 204, i.e., an amplifier, wherein the output of the second gain stage 204 can be converted to a corresponding digital signal that can be sent wirelessly to a data acquisition unit; etc.), wherein the wireless transmitter is a microcontroller with an ADC integrated therewithin (Fig. 7, where ADC 310 and wireless transmitter 314 are provided on an integrated circuit (IC) chip).
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 of Majerus to comprise amplifying, by an amplifier of the FPS device, the electrical resistance data after detection by the pressure sensor of the FPS device for transmission by the wireless transmitter, wherein the microcontroller includes the wireless transmitter and ADC integrated therein, as taught and/or suggested by Young in order to condition the sensor output for further processing and/or transmission, such as converting said output to a corresponding digital signal that can be further analyzed and/or sent wirelessly to a data acquisition unit (Young, ¶ [0041]) and/or as a simple substitution of one suitable means and/or arrangement for wirelessly transmitting detected sensor and/or determined measurement data for another to yield no more than predictable results. See MPEP 2143(I)(B).
Claim(s) 9 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of reference(s) as applied to claim(s) 1 and 21 above; or alternatively, over the combination of reference(s) as applied to claim(s) 1 and 21 above, and further in view of US 2004/0133092 A1 (previously cited, "Kain").
Regarding claims 9 and 22, Majerus as modified discloses and/or suggests the limitations of claims 1 and 21, as discussed above, but does not expressly disclose the microcontroller is configured to wake from sleep upon receiving a signal from the external device. 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 apparatus and method of Majerus with the microcontroller being configured to wake from sleep upon receiving a signal from the external device because Applicant has not disclosed that such a microcontroller provides an advantage, is used for a particular purpose, or solves a stated problem commensurate in scope with the claimed invention. Specifically, while Applicant discloses "In some instances, the sleep/wake signal 54 can conserve battery of the FPS device 10" (¶ [0055]), there is no requirement in the pending claims that the apparatus, or FPS device of the method claims, is battery-powered. Applicant fails to disclose an advantage, particular purpose for, problem solved by, etc. a microcontroller configured wake from sleep upon receiving a signal from the external device for any/all apparatuses and/or methods commensurate with the scope of the pending claims. Therefore, as no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with, e.g., a microcontroller configured for adaptive RF powering as taught and/or suggested by the cited art (e.g., Young, ¶¶ [0046]-[0060]) because either arrangement permits in vivo real-time monitoring for untethered or ambulatory subjects.
Alternatively/Additionally, Young discloses comparable apparatuses or devices may be battery powered (¶ [0053]). Kain discloses a similar apparatus comprising a microcontroller (ASIC chip 32), which may be battery-powered (¶ [0036]), wherein the microcontroller is configured to wake from sleep upon receiving a signal from an external device (e.g., scanner 2) (¶ [0032] sensor unit may comprise a low-power wakeup circuit 3 that periodically turns on a circuit that looks for a wakeup signal 20 from scanner 2). 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 apparatus/method of Majerus with the microcontroller being configured to wake from sleep upon receiving a signal from the external device as taught/suggested by Kain in order to facilitate reducing power consumption of the FPS apparatus/device, particularly for battery-powered apparatuses/devices (Kain, ¶ [0031]).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Majerus in view of Young and Kovacs.
Regarding claim 24, Majerus discloses/suggests an apparatus comprising:
a flexible pulsation sensor (FPS) (sensor apparatus 10, 52, 100) comprising a piezoresistive elastomer composite comprising conductive nanoparticles dispersed within a PDMS elastomer (¶ [0033] conductive layer comprises a piezoresistive elastomer, such as a conductive PDMS, e.g., ¶ [0023] conductive layer 12 may be formed by dispersing electrically conductive materials in a viscous polymer matrix, such as carbon nanoparticles/nanotubes or graphene flakes dispersed in PDMS), the FPS configured to wrap around a vessel or graft (¶ [0022]; ¶ [0034]; ¶ [0065]; Fig. 3; etc.) without impeding fluid flow through the vessel/graft (e.g., ¶ [0034]) and to measure displacement of the piezoresistive elastomer composite related to pressure of and/or within the vessel/graft due to pulsatile fluid flow through the vessel/graft through an entire diastolic-systolic blood pressure waveform, wherein the displacement of the piezoresistive elastomer composite is measured as electrical resistance data that is a function of a circumferential length of the FPS, which corresponds to a circumferential strain of the vessel/graft (¶ [0036] circuitry 92 of system 50 is configured to measure the electrical resistance in response to application of an AC signal (e.g., pulses) over time, wherein the electrical resistance of conductive layer 62 varies as a function of its length, corresponding to circumferential strain of the graft 54 and sensor apparatus (e.g., operating as a strain gauge), e.g., Fig. 7, Fig. 8B, Fig. 9, etc.);
a sensor interface configured to collect the electrical resistance data related to the displacement of the piezoresistive elastomer composite of the FPS (measurement circuitry 92; ¶ [0036] electrical resistance of the sensor apparatus 52 may be determined to provide measurement data, e.g., ¶¶ [0043]-[0044]);
a wireless transmitter configured to transmit data related to the displacement wirelessly to an external device (wireless communication interface 94; ¶ [0037] communicating measurement data to a remote location; etc.).
Majerus does not disclose the apparatus comprises a flexible circuit board bonded and electrically connected to the FPS, wherein the flexible circuit board comprises the sensor interface, the wireless transmitter, and an amplifier.
Young discloses an apparatus comprising a pulsation sensor device comprising a piezo-resistive element configured to detect displacement through an entire pressure waveform with fluid flow through a measurement target (¶ [0029] piezoresistive pressure sensor, or piezoresistive element thereof, configured to respond to expansion and contraction of said blood vessel); a flexible circuit board (substrate 22, which may comprise a flexible circuit board, e.g., ¶ [0029]) bonded and electrically connected the pulsation sensor (e.g., Figs. 1-3), the flexible circuit board comprising a sensor interface on the flexible circuit board configured to collect data related to displacement of the sensor (Fig. 2, ¶ [0029], chip 30 and/or components 36 mounted to substrate 22; e.g., ¶¶ [0050]-[0051] interface electronics 308); an amplifier configured to interface with the sensor interface and the wireless transmitter to amplify the data collected by the sensor interface for transmission by the wireless transmitter (¶ [0050] interface circuitry can be implemented to include conversion circuitry as described with respect to, e.g., Fig. 6; ¶ [0041] conversion circuity may include second gain stage 204, i.e., an amplifier, wherein the output of the second gain stage 204 can be converted to a corresponding digital signal that can be sent wirelessly to a data acquisition unit; etc.); and a wireless transmitter on the flexible circuit board configured to wirelessly transmit data from the sensor interface to an external device (Fig. 2, ¶ [0029], chip 30 and/or components 36 mounted to substrate 22; e.g., ¶ [0051] transmitter 314 that wirelessly transmits the signal via an antenna 316).
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 apparatus of Majerus to comprise a flexible circuit board including the sensor interface, the wireless interface, and an amplifier configured to interface with the sensor interface and the wireless interface to amplify the sensor data before transmission of said data to the external device as taught/suggested by Young in order to facilitate conditioning the sensor output for transmission and further processing (Young, ¶ [0041]), thereby providing a fully implantable monitoring device for effective in vivo real-time monitoring (Young, ¶ [0006]) for untethered or ambulatory subjects (Young, ¶ [0054]).
Majerus does not disclose the amplifier is configured to bandpass filter the electrical resistance data or amplify the electrical resistance data to fit within a full-scale voltage range. However, Young (or Majerus as modified thereby) discloses the output of the amplifier is provided to an ADC prior to transmission and/or the wireless transmitter comprises/is integrated with an ADC (e.g., ¶¶ [0050]-[0051]).
Kovacs discloses an apparatus comprising an analog sensor (¶ [0040]); and an amplifier (signal processing/conditioning circuit 52) configured to interface with the sensor to bandpass filter the sensor data (¶ [0048] filtering operations performed by filtering circuit 118 of circuit 52 include anti-aliasing, noise-rejection, and band-shaping) and amplify the electrical resistance data to fit within a full-scale voltage range (¶ [0047] amplification circuit 112 of circuit 52 amplifies received signals so that the amplitude of the signal output to ADC 58 corresponds generally to the full-scale input signal of ADC 58).
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 apparatus of Majerus with the amplifier being configured to bandpass filter the electrical resistance data and amplify the electrical resistance data to fit within a full-scale voltage range as taught/suggested by Kovacs in order to isolate frequencies of interest in the electrical resistance data, thereby reducing out-of-band noise, and to match the input range of the ADC, thereby maximizing system resolution (Kovacs, ¶¶ [0047]-[0048]).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Majerus in view of Young and Kovacs as applied to claim(s) 24 above; or alternatively, over Majerus in view of Young and Kovacs as applied to claim(s) 24 above, and further in view of US 5,404,877 A ("Nolan").
Regarding claim 25, Majerus as modified discloses/suggests the limitations of claim 24, as discussed above, but does not expressly disclose the amplifier filters the electrical resistance data in a passband between 0.2 Hz and 10 Hz to remove noise above 10 Hz, remove baseline drift below 0.2 Hz caused by the piezoresistive elastomer composite, and preserve the entire diastolic-systolic blood pressure waveform.
However, Kovacs discloses the properties of the filter circuit may be chosen according to the signal frequencies and sampling rates of interest for noise-rejection, band-shaping, etc. (e.g., ¶ [0048]). Accordingly, Kovacs discloses and/or suggests the filter properties, such as cut-off frequencies, provide a quality which can be optimized (e.g., retaining frequencies of interest, rejecting noise, etc.). Therefore, the specific claimed band pass range of 0.2 Hz and 10 Hz would have been obvious because it has been held that the discovery of optimum or workable ranges by routine experimentation is not inventive. See MPEP 2144.05(II).
Alternatively/Additionally, Nolan discloses cutoff frequencies for a bandpass filter which favors cardiac hemodynamic signals may range from 0.2 to 10 Hz (col. 12, line 68 - col. 13, line 4).
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 apparatus of Majerus with the amplifier filtering the electrical resistance data in a passband between 0.2 Hz and 10 Hz as taught/suggested by Nolan in order to remove noise and/or extraneous information outside of a range favoring cardiac hemo-dynamic signals.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Majerus in view of Young and Kovacs as applied to claim(s) 24 above, and further in view of Hilgers.
Regarding claim 26, Majerus as modified discloses/suggests the limitations of claim 24, as discussed above, and further discloses/suggests the apparatus comprises a microcontroller configured to determine a measure based on the electrical resistance data over the entire hemodynamic waveform (¶ [0036] processor implementing additional processing of the electrical resistance to provide processed measurement data, such as graft wall motion, pressure and/or flow through the site where the sensor apparatus 52 is mounted), wherein the wireless transmitter is further configured to transmit the measure of the wall tension to the external device (wireless communication interface 94; ¶ [0037] communicating measurement data to a remote location; etc.). Majerus does not disclose the microcontroller is on the flexible circuit board, or the measure(s) determined by the microcontroller include a measure of wall tension.
Hilgers discloses/suggests an apparatus comprising an FPS configured to wrap around a vessel/graft (sensor 18; ¶ [0070]; ¶ [0077]; etc.); a microcontroller (controller 20) configured to determine a measure of wall tension of the vessel/graft based on electrical resistance data over the entire hemodynamic waveform (¶ [0034]; ¶ [0082]; etc.); and a wireless transmitter configured to transmit the electrical resistance data or the measure of the wall tension wirelessly to an external device (e.g., ¶ [0035]).
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 apparatus of Majerus with the microcontroller being configured to be implanted (e.g., located on the flexible circuit board), wherein the measure(s) determined by the microcontroller include a measure of wall tension (e.g., stiffness, compliance, etc.), as taught and/or suggested by Hilgers in order to provide additional measurement data of the measurement site (i.e., vessel/graft) (Hilgers, ¶ [0082]) to the external device for diagnosis, thereby facilitating a more comprehensive diagnostic assessment of the measurement site by the external device (e.g., plaque growth, stenosis, etc.) (Hilgers, ¶ [0078]).
Majerus as modified does not expressly disclose the wireless transmitter is configured to transmit the electrical resistance data and the measure(s) determined by the microcontroller. Rather, the cited prior art appears to disclose either electrical resistance data (sensor output) or measurement data (determined measure(s)) are transmitted by the wireless transmitter (e.g., Hilgers, ¶ [0035]). 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 apparatus of Majerus with the wireless transmitter being configured to transmit the electrical resistance data and the measure(s) determined by the microcontroller to the external device for diagnostics because Applicant has not disclosed that such a microcontroller provides an advantage, is used for a particular purpose, or solves a stated problem. Indeed, as noted above with respect to rejections under 35 U.S.C. 112(a), Applicant does not appear to even disclose such a feature. Therefore, as no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with Majerus as modified above (e.g., determined measure(s) being transmitted for diagnosis) because either arrangement permits monitoring of untethered or ambulatory subjects.
Response to Arguments
To the extent Applicant's arguments are applicable to the rejections of record, said arguments have been fully considered but they are not persuasive.
Applicant contends, "Claim 14 is directed to an improved version of an FPS compared to that disclosed in Majerus. Specifically claim 14 recites use of a piezoresistive elastomer composite, which is fundamentally and structurally different from a traditional layered sensor of Majerus in terms of sensitivity. The piezoresistive elastomer composite is more sensitive to changes in the circumferential strain of the vessel or the graft from pulsatile fluid flow through the vessel or the graft. The electrical resistance data detected by the FPS is a function of the displacement of the piezoresistive elastomer composite throughout the entire body of the FPS so the piezoresistive elastomer composite with conductive particles dispersed therein has an inherently stronger sensing ability than the layered sensor described by Majerus" (Remarks, pg. 10).
To the extent Applicant appears to be contending that Majerus does not disclose the FPS as claimed, the examiner respectfully disagrees. As noted in the rejection of record, Majerus discloses a sensor, or FPS, includes a conductive layer comprising a piezoresistive elastomer composite having conductive particles dispersed within an elastomer (¶ [0023] "The conductive layer 12 may be formed by dispersing electrically conductive materials in a viscous polymer matrix. For example, the conductive materials may include micron or submicron conductive particles, such as carbon nanoparticles or graphene flakes. As one example, the conductive particles include a matrix of multi-walled carbon nanotubes (MWCNTs)) dispersed in PDMS, which are applied over a substrate 14 to form the conductive layer 12"). Applicant fails to define what constitutes a "traditional layered sensor," but the structure of Majerus appears to be comparable to that disclosed by Applicant. Specifically, Majerus discloses the above-noted conductive layer may be sandwiched between PDMS substrate layers. This is analogous to the structure disclosed by Applicant, e.g., a conductive PDMS sensing layer sandwiched between substrate/pure PDMS layers (e.g., ¶ [0076]). Majerus further discloses the sensor "is sufficiently compliant to deform in a radial or circumferential direction corresponding to sensor strain (e.g., from about 0% to about 20% strain) in response to pulsatile blood flow through the graft that causes graft wall motion. Such deformation causes a change in electrical resistance in the conductive layer 62 that can be measured over time" (¶ [0033]), i.e., over or throughout an entire hemodynamic waveform (e.g., Fig. 7). It is unclear what structural differences exist between the sensor the present application and the sensor of Majerus and/or in what manner the sensor is more sensitive, and no such structural difference is sufficiently captured by the language of the claims.
Applicant further contends Young does not remedy the alleged deficiencies of Majerus. Specifically, Applicant contends, "The sensing portion of Young does not wrap around the blood vessel (and thus is not capable of accurately measuring wall tension);" "Young is silent regarding a sensor that utilizes a piezoresistive elastomer composite with conductive particles dispersed therein, let alone one that wraps around a blood vessel as discussed above;" and "Young is also silent about measuring wall tension or a sensor comprising a microcontroller to measure wall tension through an entire hemodynamic waveform and only describes measuring blood pressure" (Remarks, pg. 14). However, Young was not previously, and is not currently, relied on as a disclosure or suggestion of any of the above-noted features, as discussed in the rejections of record above.
Conclusion
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/Meredith Weare/Primary Examiner, Art Unit 3791
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