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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10, and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "a system for providing guidance during a procedure to remove tissue vegetation, the device comprising". There is insufficient antecedent basis for the device in the claim. It is unclear what “the device” is referring to. For examination purposes the claim will be interpreted as “a system for providing guidance during a procedure to remove tissue vegetation, the system comprising”. Claims 2-10 are also rejected due to their dependency.
Claim 1 recites the limitation "provide guidance for the aspiration". There is insufficient antecedent basis for the aspiration in the claim. It is unclear what “the aspiration” is referring to. It is recommended by the examiner to amend the limitation of “wherein the aspiration catheter is configured to remove the tissue vegetation from the implant site” to recite “wherein the aspiration catheter is configured to perform aspiration by removing the tissue vegetation from the implant site”. Claims 2-10 are also rejected due to their dependency.
Claim 9 recites the limitation "the material to be removed is tissue vegetation". The material to be removed has not been previously defined in claims 1 or 9 therefore there is insufficient antecedent basis for the material to be removed in the claim. It is unclear what “the material to be removed” is referring to. For examination purposes the claim will be interpreted as "material to be removed is tissue vegetation".
Claim 15 recites the limitation "automatically turn off the vacuum suction". The vacuum suction has not been previously defined therefore there is insufficient antecedent basis for the vacuum suction in the claim. It is unclear what “the vacuum suction” is referring to. For examination purposes the claim will be interpreted as "automatically turn off vacuum suction".
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:
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.
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.
Claims 1, 2, 10-12, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Look (US 20220008090) and further in view of Hansen (US 20160354057).
Regarding claim 1, Look discloses a system for providing guidance during a procedure to remove tissue vegetation (Abstract – “A system for removal of blood or thrombus includes an aspiration catheter”, [0082] – “Communication device 58 b may create a characteristic sound, or may generate an audio message in a number of languages. For example, the audio message may state, “Thrombus being aspirated.”…When the user realizes that the thrombus is being aspirated, the user may choose to advance (or retract) the aspiration catheter 4”), the device comprising:
[…] acquire ultrasound data of an implant site including Doppler ultrasound data […] ([0091] – “an additional or alternate sensor may be used to monitor flow conditions for the notification of the user, including, but not limited to: a Doppler sensor, an infrared sensor, or a laser flow detection device. In some embodiments, an externally-attached Doppler sensor may be employed”); and
a processor ([0068] – “measurement device 54, which in some embodiments may comprise a microprocessor”) configured to:
[…] wherein the aspiration catheter is configured to remove the tissue vegetation from the implant site ([0004] – “a system for removal of blood or thrombus includes a vacuum source, an aspiration catheter having an elongate shaft including an aspiration lumen”, one with ordinary skill in the art would find it obvious that a aspiration catheter used in the blood vessels could be used in an implant site);
measure fluid flow through the aspiration catheter as a function of time based on the Doppler ultrasound data corresponding to the identified portion of the aspiration catheter ([0070] – “The aspiration monitoring system 48 of FIG. 2A is configured to alert users of an aspiration system 2 about real time status of the aspiration system 2, including operational conditions, which include…flow conditions”, [0091] – “an additional or alternate sensor may be used to monitor flow conditions for the notification of the user, including, but not limited to: a Doppler sensor…an externally-attached Doppler sensor may be employed”); and
provide guidance for the aspiration based on the measured fluid flow through the aspiration catheter ([0070] – “alert users of an aspiration system 2 about real time status of the aspiration system 2, including operational conditions, which include: whether vacuum is being applied or not; flow conditions”, [0082] – “Communication device 58 b may create a characteristic sound…For example, the audio message may state, “Thrombus being aspirated.”…When the user realizes that the thrombus is being aspirated, the user may choose to advance (or retract) the aspiration catheter 4”).
Conversely Look does not teach a Doppler ultrasound imaging device configured to acquire ultrasound data of an implant site including Doppler ultrasound data of the implant site and imaging data of the implant site; and
identify a portion of an aspiration catheter in the imaging data of the implant site.
However Hansen discloses a Doppler ultrasound imaging device configured to acquire ultrasound data of an implant site including Doppler ultrasound data of the implant site and imaging data of the implant site ([0023] – “data may be processed by other or different mode-related modules by the processor 116 (e.g., B-mode…one or more modules may generate B-mode, color Doppler, M-mode, color M-mode, spectral Doppler, Elastography, TVI, strain, strain rate and combinations thereof”, [0004] – “when the implantable medical device is a valve and the procedure includes replacing a mitral valve or an aortic valve”); and
identify a portion of an aspiration catheter in the imaging data of the implant site ([0037] – “image processing techniques may be used to detect the position of the catheter 306 in real-time based on the live image generated from the 3D real-time ultrasound data”, [0004] – “when the implantable medical device is a valve and the procedure includes replacing a mitral valve or an aortic valve”).
The disclosure of Hansen is an analogous art considering it is in the field of Doppler sensing of a catheter.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Look to incorporate the ultrasound imaging data of Hansen to achieve the same results. One would have motivation to combine because it would allow one to produce an image and receive blood flow information from the same device while decreasing radiation from fluoroscopy and angiogram imaging.
Regarding claim 2, Look and Hansen disclose all the elements of the claimed invention as cited in claim 1.
Conversely Look does not teach wherein the Doppler ultrasound imaging device is configured to acquire the imaging data of the implant site as B-mode ultrasound imaging data of the implant site, and the processor is configured to:
identify the portion of the aspiration catheter in the B-mode imaging data of the implant site.
However Hansen discloses wherein the Doppler ultrasound imaging device is configured to acquire the imaging data of the implant site as B-mode ultrasound imaging data of the implant site ([0023] – “data may be processed by other or different mode-related modules by the processor 116 (e.g., B-mode”, [0004] – “when the implantable medical device is a valve and the procedure includes replacing a mitral valve or an aortic valve”), and the processor is configured to:
identify the portion of the aspiration catheter in the B-mode imaging data of the implant site ([0037] – “image processing techniques may be used to detect the position of the catheter 306 in real-time based on the live image generated from the 3D real-time ultrasound data”, [0023] – “data may be processed by other or different mode-related modules by the processor 116 (e.g., B-mode”, [0004] – “when the implantable medical device is a valve and the procedure includes replacing a mitral valve or an aortic valve”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Look to incorporate the ultrasound imaging data of Hansen to achieve the same results. One would have motivation to combine because it would allow one to produce an image and receive blood flow information from the same device while decreasing radiation from fluoroscopy and angiogram imaging.
Regarding claim 10, Look and Hansen disclose all the elements of the claimed invention as cited in claim 1.
Look further discloses the aspiration catheter configured to aspirate material to be removed from the implant site in at least one blood vessel of a patient using vacuum suction on the aspiration catheter ([0004] – “a system for removal of blood or thrombus includes a vacuum source, an aspiration catheter having an elongate shaft including an aspiration lumen”, [0074] – “FIG. 4A illustrates the distal end 16 of an aspiration catheter 4 within a blood vessel 86 having at least one thrombus 88”, one with ordinary skill in the art would find it obvious that a aspiration catheter used in the blood vessels could be used in an implant site of a blood vessel).
Regarding claim 11, Look discloses an intravascular aspiration system (Abstract – “A system for removal of blood or thrombus includes an aspiration catheter”, Figs. 4A-4D), comprising:
an aspiration catheter configured to aspirate material to be removed from a treatment site in at least one blood vessel of a patient using vacuum suction on the aspiration catheter ([0004] – “a system for removal of blood or thrombus includes a vacuum source, an aspiration catheter having an elongate shaft including an aspiration lumen”, Abstract – “A system for removal of blood or thrombus includes an aspiration catheter”, Figs. 4A-4D);
[…] acquire ultrasound data of an treatment site including Doppler ultrasound data of the treatment site ([0091] – “an additional or alternate sensor may be used to monitor flow conditions for the notification of the user, including, but not limited to: a Doppler sensor, an infrared sensor, or a laser flow detection device. In some embodiments, an externally-attached Doppler sensor may be employed”) […]; and
a processor configured to provide real-time guidance for the aspiration of the treatment site ([0082] – “Communication device 58 b may create a characteristic sound, or may generate an audio message in a number of languages. For example, the audio message may state, “Thrombus being aspirated.”…When the user realizes that the thrombus is being aspirated, the user may choose to advance (or retract) the aspiration catheter 4”, [0070] – “The aspiration monitoring system 48 of FIG. 2A is configured to alert users of an aspiration system 2 about real time status of the aspiration system 2”), the processor configured to:
measure fluid flow through the aspiration catheter as a function of time based on the Doppler ultrasound data corresponding to the identified portion of the aspiration catheter ([0070] – “The aspiration monitoring system 48 of FIG. 2A is configured to alert users of an aspiration system 2 about real time status of the aspiration system 2, including operational conditions, which include…flow conditions”, [0091] – “an additional or alternate sensor may be used to monitor flow conditions for the notification of the user, including, but not limited to: a Doppler sensor…an externally-attached Doppler sensor may be employed”); and
provide guidance for the aspiration based on the measured fluid flow through the aspiration catheter ([0070] – “alert users of an aspiration system 2 about real time status of the aspiration system 2, including operational conditions, which include: whether vacuum is being applied or not; flow conditions”, [0082] – “Communication device 58 b may create a characteristic sound…For example, the audio message may state, “Thrombus being aspirated.”…When the user realizes that the thrombus is being aspirated, the user may choose to advance (or retract) the aspiration catheter 4”).
Conversely Look does not teach a Doppler ultrasound imaging device configured to acquire ultrasound data of the treatment site including Doppler ultrasound data of the treatment site and imaging data of the treatment site; and
identify a portion of an aspiration catheter in the imaging data of the treatment site.
However Hansen discloses a Doppler ultrasound imaging device configured to acquire ultrasound data of the treatment site including Doppler ultrasound data of the treatment site and imaging data of the treatment site ([0023] – “data may be processed by other or different mode-related modules by the processor 116 (e.g., B-mode…one or more modules may generate B-mode, color Doppler, M-mode, color M-mode, spectral Doppler, Elastography, TVI, strain, strain rate and combinations thereof”, [0004] – “when the implantable medical device is a valve and the procedure includes replacing a mitral valve or an aortic valve”); and
identify a portion of an aspiration catheter in the imaging data of the treatment site ([0037] – “image processing techniques may be used to detect the position of the catheter 306 in real-time based on the live image generated from the 3D real-time ultrasound data”, [0004] – “when the implantable medical device is a valve and the procedure includes replacing a mitral valve or an aortic valve”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Look to incorporate the ultrasound imaging data of Hansen to achieve the same results. One would have motivation to combine because it would allow one to produce an image and receive blood flow information from the same device while decreasing radiation from fluoroscopy and angiogram imaging.
Regarding claim 12, Look and Hansen disclose all the elements of the claimed invention as cited in claim 11.
Conversely Look does not teach wherein the Doppler ultrasound imaging device is configured to acquire the imaging data of the treatment site as B-mode ultrasound imaging data of the treatment site, and the processor is configured to:
identify the portion of the aspiration catheter in the B-mode imaging data of the treatment site.
However Hansen discloses wherein the Doppler ultrasound imaging device is configured to acquire the imaging data of the treatment site as B-mode ultrasound imaging data of the treatment site ([0023] – “data may be processed by other or different mode-related modules by the processor 116 (e.g., B-mode”, [0004] – “when the implantable medical device is a valve and the procedure includes replacing a mitral valve or an aortic valve”), and the processor is configured to:
identify the portion of the aspiration catheter in the B-mode imaging data of the treatment site ([0037] – “image processing techniques may be used to detect the position of the catheter 306 in real-time based on the live image generated from the 3D real-time ultrasound data”, [0023] – “data may be processed by other or different mode-related modules by the processor 116 (e.g., B-mode”, [0004] – “when the implantable medical device is a valve and the procedure includes replacing a mitral valve or an aortic valve”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Look to incorporate the ultrasound imaging data of Hansen to achieve the same results. One would have motivation to combine because it would allow one to produce an image and receive blood flow information from the same device while decreasing radiation from fluoroscopy and angiogram imaging.
Regarding claim 19, Look discloses an intravascular aspiration method for removing tissue vegetation from an implant site in at least one blood vessel of a patient ([0005] – “a method for removing thromboembolic material from a blood vessel in a patient”, one with ordinary skill in the art would find it obvious that a aspiration catheter used in the blood vessels could be used in an implant site), the method comprising:
performing an aspiration procedure using an aspiration catheter to aspirate tissue vegetation from the implant site ([0005] – “a method for removing thromboembolic material from a blood vessel in a patient includes providing a catheter having a lumen…applying negative pressure to the lumen for a first period of time to draw at least a portion of the body of thromboembolic material into the lumen”);
acquiring ultrasound data of an implant site during the aspiration procedure including Doppler ultrasound data […] ([0091] – “an additional or alternate sensor may be used to monitor flow conditions for the notification of the user, including, but not limited to: a Doppler sensor, an infrared sensor, or a laser flow detection device. In some embodiments, an externally-attached Doppler sensor may be employed”); and
using an electronic processor ([0068] – “measurement device 54, which in some embodiments may comprise a microprocessor”) […]
using the electronic processor, measuring fluid flow through the aspiration catheter as a function of time based on the Doppler ultrasound data corresponding to the identified portion of the aspiration catheter ([0068] – “measurement device 54, which in some embodiments may comprise a microprocessor”, [0070] – “The aspiration monitoring system 48 of FIG. 2A is configured to alert users of an aspiration system 2 about real time status of the aspiration system 2, including operational conditions, which include…flow conditions”, [0091] – “an additional or alternate sensor may be used to monitor flow conditions for the notification of the user, including, but not limited to: a Doppler sensor…an externally-attached Doppler sensor may be employed”); and
providing guidance for the aspiration procedure based on the measured fluid flow through the aspiration catheter ([0070] – “alert users of an aspiration system 2 about real time status of the aspiration system 2, including operational conditions, which include: whether vacuum is being applied or not; flow conditions”, [0082] – “Communication device 58 b may create a characteristic sound…For example, the audio message may state, “Thrombus being aspirated.”…When the user realizes that the thrombus is being aspirated, the user may choose to advance (or retract) the aspiration catheter 4”).
Conversely Look does not teach acquiring ultrasound data of an implant site […] including Doppler ultrasound data of the implant site and imaging data of the implant site; and
using an electronic processor, identifying a portion of an aspiration catheter in the imaging data of the implant site.
However Hansen discloses acquiring ultrasound data of an implant site […] including Doppler ultrasound data of the implant site and imaging data of the implant site ([0023] – “data may be processed by other or different mode-related modules by the processor 116 (e.g., B-mode…one or more modules may generate B-mode, color Doppler, M-mode, color M-mode, spectral Doppler, Elastography, TVI, strain, strain rate and combinations thereof”, [0004] – “when the implantable medical device is a valve and the procedure includes replacing a mitral valve or an aortic valve”); and
using an electronic processor, identifying a portion of an aspiration catheter in the imaging data of the implant site ([0020] – “the processor 116 may process the ultrasound data into images for display on the display device 118”, [0037] – “image processing techniques may be used to detect the position of the catheter 306 in real-time based on the live image generated from the 3D real-time ultrasound data”, [0004] – “when the implantable medical device is a valve and the procedure includes replacing a mitral valve or an aortic valve”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Look to incorporate the ultrasound imaging data of Hansen to achieve the same results. One would have motivation to combine because it would allow one to produce an image and receive blood flow information from the same device while decreasing radiation from fluoroscopy and angiogram imaging.
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Look (US 20220008090) and Hansen (US 20160354057) as applied to claims 1 and 11 above, and further in view of Yang NPL 2018 (“Feature study on catheter detection in three-dimensional ultrasound”).
Regarding claims 3 and 13, Look and Hansen disclose all the elements of the claimed invention as cited in claims 1 and 11.
As cited above Look discloses an aspiration catheter and Hansen discloses imaging data of the implant/treatment site.
Conversely Look does not teach wherein the processor is configured to identify the portion of the […] catheter in the imaging data […] based in part on an a priori known diameter of the portion of the […] catheter.
However Yang discloses wherein the processor is configured to identify the portion of the […] catheter in the imaging data […] based in part on an a priori known diameter of the portion of the […] catheter (pg. 1 – “US image-based medical tool detection has been studied over the last years…require prior knowledge of the instrument’s direction and diameter”).
The disclosure of Yang is an analogous art considering it is in the field of image-guided interventions for catheterization.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Look to incorporate the identification of the catheter in ultrasound imaging data based on the diameter of Yang to achieve the same results. One would have motivation to combine because it would allow one to produce an image to identify the catheter while decreasing radiation from fluoroscopy and angiogram imaging.
Claims 4-7, 14-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Look (US 20220008090) and Hansen (US 20160354057) as applied to claims 1, 11, and 19 above, and further in view of Zabar (US 20230149033).
Regarding claims 4 and 14, Look and Hansen disclose all the elements of the claimed invention as cited in claims 1 and 11.
Conversely Look does not teach wherein, to provide the guidance for the aspiration, the processor is configured to:
determine whether the measured fluid flow through the aspiration catheter exceeds a predetermined fluid flow threshold, and
output an alert if the measured fluid flow exceeds the predetermined fluid flow threshold.
However Zabar discloses wherein, to provide the guidance for the aspiration (Abstract – “dynamically modulating aspiration in response to sensed conditions. An aspiration system can include a catheter”), the processor is configured to ([0090] – “computer system 310 for monitoring the status of the treatment procedure and controlling the operation of the other components of the system 300”):
determine whether the measured fluid flow through the aspiration catheter exceeds a predetermined fluid flow threshold (Abstract – “dynamically modulating aspiration in response to sensed conditions. An aspiration system can include a catheter”, [0096] – “once blood aspiration reaches about 400 mL, the computer system 310 can issue a second alert”), and
output an alert if the measured fluid flow exceeds the predetermined fluid flow threshold ([0096] – “once blood aspiration reaches about 400 mL, the computer system 310 can issue a second alert”).
The disclosure of Zabar is an analogous art considering it is in the field of catheter aspiration.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Look to incorporate the alert for fluid flow exceeding a threshold value of Zabar to achieve the same results. One would have motivation to combine because it would allow one to be aware of the risk of excessive blood loss.
Regarding claims 5 and 15, Look, Hansen, and Zabar disclose all the elements of the claimed invention as cited in claims 1, 4, 11, and 14.
Look further discloses wherein the aspiration by the aspiration catheter is controlled by vacuum suction ([0074] – “A vacuum source 6 (FIG. 1) has been coupled to the aspiration lumen 18 of the aspiration catheter 4 and activated (i.e. the valve 8 is open) causing blood 96 to be aspirated into the aspiration lumen 18”),
Conversely Look does not teach the processor is further configured to:
automatically turn off or modulate the vacuum suction if the measured fluid flow exceeds the predetermined fluid flow threshold.
However Zabar discloses the processor is further configured to ([0090] – “computer system 310 for monitoring the status of the treatment procedure and controlling the operation of the other components of the system 300”):
automatically turn off or modulate the vacuum suction if the measured fluid flow exceeds the predetermined fluid flow threshold ([0096] – “once blood aspiration reaches about 400 mL, the computer system 310 can issue a second alert or warning or even be configured to automatically shut off”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Look to incorporate automatically turning off the vacuum when fluid flow exceeds a threshold value of Zabar to achieve the same results. One would have motivation to combine because it would help prevent the risk of excessive blood loss.
Regarding claims 6 and 16, Look, Hansen, and Zabar disclose all the elements of the claimed invention as cited in claims 1, 4, 5, 11, 14, and 15.
Look further discloses output an indication that the aspiration catheter has engaged material to be removed ([0075] – “the measurement device 54, 64 then sends a signal to the communication device 58 a-c, 74, and the communication device 58 a-c, 74 generates an appropriate alert…may generate an audio message in a number of languages. For example, the audio message may state, “Thrombus encountered,””).
Conversely Look does not teach wherein, to provide the guidance for the aspiration, the processor is further configured to:
detect a decrease in the measured fluid flow through the aspiration catheter as a function of time; and
in response to the detected decrease in the measured fluid flow through the aspiration catheter, output a […response].
However Zabar discloses wherein, to provide the guidance for the aspiration, the processor is further configured to ([0090] – “computer system 310 for monitoring the status of the treatment procedure and controlling the operation of the other components of the system 300”):
detect a decrease in the measured fluid flow through the aspiration catheter as a function of time ([0096] – “when a normal or steady aspiration flow rate is observed within the system 300, such flow rate may be about 20-50 mL/min…When the sensed aspiration flow rate is below about 20 mL/min, there may be a partial blockage (i.e., not a complete blockage or clog)”); and
in response to the detected decrease in the measured fluid flow through the aspiration catheter, output a […response] ([0096] – “When the sensed aspiration flow rate is below about 20 mL/min, there may be a partial blockage (i.e., not a complete blockage or clog). In this state, the control element 314 could be utilized to increase the vacuum level as will be sensed by the catheter tip thereby helping to clear the partial blockage”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Look to incorporate the detection of a decrease in fluid flow and produce a response in response to the detected decrease of Zabar to achieve the same results. One would have motivation to combine because it would allow for an appropriate change of vacuum pressure to be made to aspirate the unwanted tissue.
Regarding claims 7 and 17, Look, Hansen, and Zabar disclose all the elements of the claimed invention as cited in claims 1, 4, 5, 6, 11, 14, 15, and 16.
Conversely Look does not teach Conversely Look does not teach wherein the processor is further configured to:
automatically set the vacuum suction to a probing vacuum suction value at an initial stage of the aspiration; and
automatically increase the vacuum suction to an aspiration vacuum suction value that is higher than the probing vacuum suction value in response to the detected decrease in the measured fluid flow through the aspiration catheter.
However Zabar discloses wherein the processor is further configured to ([0090] – “computer system 310 for monitoring the status of the treatment procedure and controlling the operation of the other components of the system 300”):
automatically set the vacuum suction to a probing vacuum suction value at an initial stage of the aspiration (The abstract discloses that the computer initiates vacuum pressure and modulates the vacuum pressure based on what is sensed by the sensor therefore it is automatic, [0096] – “when a normal or steady aspiration flow rate is observed within the system 300, such flow rate may be about 20-50 mL/min. At this state, the vacuum level at the catheter tip is maintained and held at about 120-750 torr”); and
automatically increase the vacuum suction to an aspiration vacuum suction value that is higher than the probing vacuum suction value in response to the detected decrease in the measured fluid flow through the aspiration catheter (The abstract discloses that the computer initiates vacuum pressure and modulates the vacuum pressure based on what is sensed by the sensor therefore it is automatic, [0096] – “When the sensed aspiration flow rate is below about 20 mL/min, there may be a partial blockage (i.e., not a complete blockage or clog). In this state, the control element 314 could be utilized to increase the vacuum level”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Look to incorporate the detection of a decrease in fluid flow and automatically increase the vacuum suction in response to the detected decrease of Zabar to achieve the same results. One would have motivation to combine because it would allow for an appropriate change of vacuum pressure to be made to aspirate the unwanted tissue and allow the user to focus more on the patient.
Regarding claim 20, Look and Hansen disclose all the elements of the claimed invention as cited in claim 19.
Conversely Look does not teach wherein the implant site in the at least one blood vessel is a trans-venous lead anchor site, and the performing of the aspiration procedure includes using the aspiration catheter to aspirate tissue vegetation from the trans-venous lead anchor site.
However Zabar discloses wherein the implant site in the at least one blood vessel is a trans-venous lead anchor site, and the performing of the aspiration procedure includes using the aspiration catheter to aspirate tissue vegetation from the trans-venous lead anchor site ([0069] – “treatment sites, or target areas include, but are not limited to, systemic venous circulation…treatment sites or target areas could include pacemaker leads”, [0070] – “This disclosure relates to devices and methods for minimally invasive removal of UIM from a vessel”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Look to incorporate aspiration of tissue vegetation of a trans-venous lead of Zabar to achieve the same results. One would have motivation to combine because it could prevent future health risks.
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Look (US 20220008090) and Hansen (US 20160354057) as applied to claims 1 and 11 above, and further in view of Miller (US 20210330946) and Saadat (US 20220409230).
Regarding claims 8 and 18, Look and Hansen disclose all the elements of the claimed invention as cited in claims 1 and 11.
As cited above Look discloses a doppler sensor to sense flow through an aspiration catheter.
Conversely Look does not teach wherein the processor is further configured to:
measure a density of fluid forming the measured fluid flow […]; and
determine an amount of material to be removed that passes through the aspiration catheter based on the measured fluid flow and the measured density.
However Miller discloses wherein the processor is further configured to ([0164] – “processor 200 may use the average transit time of the upstream and downstream direction, e.g., to calculate characteristics of fluid 504”):
measure a density of fluid forming the measured fluid flow ([0056] – “determine (e.g., via processing circuitry) at least one of a density parameter or a temperature parameter of the fluid in lumen 34 based on the sensed flow parameter of the fluid”) […];
The disclosure of Miller is an analogous art considering it is in the field of sensing flow through a catheter.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Look to incorporate the measurement of density of Miller to achieve the same results. One would have motivation to combine because it would allow one to understand what type of tissue is being aspirated.
Conversely Look and Miller do not teach determine an amount of material to be removed that passes through the […] catheter based on the measured fluid flow and the measured density.
However Saadat discloses determine an amount of material to be removed that passes through the […] catheter based on the measured fluid flow and the measured density ([0332] – “the controller may monitor fluctuations in current drawn by the motor 10 in order to measure clot attributes including but not limited to volume”, one with ordinary skill in the art would recognize volume can be determined based on a value of density (volume=mass/density), as cited by the Miller reference above density can be determined based on a fluid flow parameter).
The disclosure of Saadat is an analogous art considering it is in the field of an aspiration catheter.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Look to incorporate the measurement of volume of Saadat to achieve the same results. One would have motivation to combine because it would allow one to understand how much tissue is being removed which can be used to determine the progress of the procedure.
Claim 9 are rejected under 35 U.S.C. 103 as being unpatentable over Look (US 20220008090) and Hansen (US 20160354057) as applied to claim 1 above, and further in view of Zabar (US 20230149033) and Al-Jadda (WO 2022261448).
Regarding claim 9, Look and Hansen disclose all the elements of the claimed invention as cited in claim 1.
Conversely Look does not teach wherein the implant site is a trans-venous lead anchoring site, the material to be removed is tissue vegetation at the trans-venous lead anchoring site, and the processor is further configured to:
quantify an amount of the tissue vegetation at the trans-venous lead anchoring site based on the imaging data of the implant site.
However Zabar discloses wherein the implant site is a trans-venous lead anchoring site, the material to be removed is tissue vegetation at the trans-venous lead anchoring site ([0069] – “treatment sites, or target areas include, but are not limited to, systemic venous circulation…treatment sites or target areas could include pacemaker leads”, [0070] – “This disclosure relates to devices and methods for minimally invasive removal of UIM from a vessel”),
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Look to incorporate aspiration of tissue vegetation of a trans-venous lead of Zabar to achieve the same results. One would have motivation to combine because it could prevent future health risks.
Conversely Look and Zabar do not teach the processor is further configured to:
quantify an amount of the tissue vegetation […] based on the imaging data of the […] site.
However Al-Jadda discloses the processor is further configured to ([0207] – “image processing”):
quantify an amount of the tissue vegetation […] based on the imaging data of the […] site ([0208] – “compare pre-treatment imaging to post- treatment imaging, determine the volume of pre-treatment clot to post- treatment clot”, [0206] – “obtaining pre-treatment images of the clot to be removed or treated. In some embodiments, this can include obtaining…ultrasound images”).
The disclosure of Al-Jadda is an analogous art considering it is in the field of an aspiration catheter.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Look to incorporate the quantification of a volume of the tissue to be removed based on image data of Saadat to achieve the same results. One would have motivation to combine because it would allow one to “identify the volume or percentage of clot removed” (Al-Jadda [0208]).
Conclusion
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/R.C.L./ Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797
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