DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 10 and 17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, Rockwood is no longer relied upon to be modified to include the pressure sensors of Ben-Abraham and thus is no longer relied upon to disclose the amended limitations of “at least one first sensor is positioned that is configured to detect fluid characteristics proximal from the first inflatable balloon” and “in which at least one second sensor is positioned that is configured to detect fluid characteristics proximal from the second inflatable balloon”. A new grounds of rejection is provided below utilizing Ravikumar (US 2024/0090901 A1), in view of Ben-Abrahams (previously of record). Both Ravikumar and Ben-Abrahams disclose occlusion catheters configured to isolate and occlude blood flow through the vasculature, specifically in and around the aortic vessels and vena cava.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3-6, 8-10, 12-15, 17 and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ravikumar (US 2024/0090901 A1) in view of Ben-Abraham (US 2025/0099744 A1)(previously of record).
Regarding claim 1, Ravikumar discloses:
A catheter (see Fig. 15A) comprising:
an elongated member (catheter shaft 102, see Fig. 15A) with a plurality of lumens therein (see Para. [0054]-[0055] mentioning a plurality of inflation lumens (112, 114A, 114B, 114C, 114D) extending through the catheter body; see also Fig. 15A), the elongated member having a distal end and a proximal end defining a length of the elongated member (see Fig. 15A), a first of the plurality of lumens extending to a first opening at the distal end of the elongated member (lumen 112 receiving wire 107 therein, see Para. [0081] and Fig. 15A);
a first inflatable balloon disposed about the elongated member adjacent the distal end (balloon 104A, see Fig. 15A), a second of the plurality of lumens (lumen 114A, see Fig. 15A) extending to a second opening at an interior of the first inflatable balloon for inflating the first inflatable balloon (see Para. [0084]);
a second inflatable balloon (balloon 104B, see Fig. 15A) disposed about the elongated member at a position proximal from the first inflatable balloon (see Fig. 15A) forming a first gap between the first inflatable balloon and the second inflatable balloon (see Fig. 15A showing a gap along the catheter body between balloons 104A and 104B), a third of the plurality of lumens extending to a third opening at an interior of the second inflatable balloon (lumen 114B, see Fig. 15A) for inflating the second inflatable balloon (see Para. [0084]).
However, Ravikumar does not expressly disclose:
a fourth of the plurality of lumens extending to a fourth opening in the first gap in which at least one first sensor is positioned that is configured to detect fluid characteristics proximal from the first inflatable balloon; and
a fifth of the plurality of lumens extending to a fifth opening at a position proximal from the second inflatable balloon in which at least one first sensor is positioned that is configured to detect fluid characteristics proximal from the first inflatable balloon; and
In the same field of endeavor, namely occluding balloon catheters configured to be used within the vasculature and through the vena cava to occlude and isolate portions of a desired vessel/artery, Ben-Abraham teaches wherein an occluding balloon catheter device (see Fig. 2), configured to isolate a desired portion of the aortic vasculature/vena cava, comprising a first balloon (expandable member 32, see Fig. 2) and a second balloon (expandable member 30, see Fig. 2) may comprise separate inflation lumens to separately inflate both balloons (see Para. [0069]); the catheter may further comprise additional sensing lumens (see Para. [0070] and Figs. 3-4 showing sensing lumens 40, 42, 44 and 46) that extend from the proximal hub of the device (see Para. [0076]) and are configured to allow sensing members (76, 78, 80 and 82) to extend therethrough (see Para. [0070]) up to a respective aperture (66, 68, 72, 74, see Figs. 5-6); wherein said respective sensing apertures are positioned such that one aperture is located proximally of each balloon and another aperture is located distally of each balloon (see Figs. 5-6 and Para. [0070], [0079] and [0083]) to measure fluid pressure and/or any other physiological parameter present at locations both proximally and distally of each expandable member (see Para. [0023] and [0083]) which allows a user to check for blood flow/pressure at locations both proximally and distally to each balloon to determine whether a desired occlusion type within the desired working site has been achieved (see Para. [0095]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the vasculature occluding balloon catheter of Ravikumar to comprise additional lumens extending from the proximal handle to respective apertures both proximally and distally of each balloon that are configured to receive fluid sensor members within each of said respective apertures as taught and suggested by Ben-Abraham to, in this case, measure fluid characteristics (i.e., blood pressure of blood flow) at locations both proximally and distally of each balloon to determine blood flow and/or blood pressure at locations proximally and distally of the respective balloons (see Ben-Abraham Para. [0070], [0079], [0083] and [0095]). Since the balloons of Ravikumar are configured to inflate sequentially in order to isolate a target vessel location (see Ravikumar Para. [0060]-[0063]), the sensor members would allow a user to determine whether each balloon has effectively occluded the target vessel area before inflating the other balloons in sequence. The additional sensing lumen extending to a corresponding aperture within the gap between the first and second balloons are defined as the “fourth lumen” and “fourth opening” respectively (see Examiner’s Diagram of Ravikumar Fig. 15A below for location reference). The additional sensing lumen extending to a corresponding aperture proximal to the second balloon are defined as the “fifth lumen” and “fifth opening” respectively (see Examiner’s Diagram of Ravikumar Fig. 15A below for location reference).
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Examiner’s Diagram of Ravikumar Fig. 15A
Regarding claim 3, the combination of Ravikumar and Ben-Abraham disclose the invention of claim 1, Ravikumar, as modified by Ben-Abraham, further discloses:
a third inflatable balloon (balloon 104C, see Ravikumar Fig. 15A) disposed about the elongated member at a position proximal from the second inflatable balloon (see Ravikumar Fig. 15A) forming a second gap between the second inflatable balloon and the third inflatable balloon (see Ravikumar Fig. 15A showing a gap between balloons 104B and 104C), a sixth of the plurality of lumens (lumen 114C, see Ravikumar Para. [0054]-[0055]) extending to a sixth opening at an interior of the third inflatable balloon (see Ravikumar Para. [0054]-[0055]) for inflating the third inflatable balloon (see Ravikumar Para. [0054]-[0055]); and
a seventh of the plurality of lumens extending to a seventh opening at a position proximal from the third inflatable balloon in which at least one third sensor is positioned that is configured to detect fluid characteristics proximal from the third inflatable balloon (the additional sensing lumen of Ravikumar, as incorporated from the teachings of Ben-Abraham, extending to a corresponding aperture proximal to the third balloon are defined as the “seventh lumen” and “seventh opening” respectively; see Examiner’s Diagram of Ravikumar Fig. 15A above for location reference);
wherein the fifth opening is positioned in the second gap (the “fifth opening” of Ravikumar, as incorporated from the teachings of Ben-Abraham and located proximal to second balloon is disposed within the gap between the second balloon 104B and third balloon 104C; see Examiner’s Diagram of Ravikumar Fig. 15A above for location reference).
Regarding claim 4, the combination of Ravikumar and Ben-Abraham disclose the invention of claim 1, Ravikumar, as modified by Ben-Abraham, further discloses wherein each of the at least one first sensor and the at least one second sensor comprises pressure transducers, ultrasound transducers, sonic tips, flow sensors, or combinations thereof (see Ben-Abraham Para. [0090] mentioning wherein the sensor members may be comprised of flow sensors).
Regarding claim 5, the combination of Ravikumar and Ben-Abraham disclose the invention of claim 1, Ravikumar further discloses wherein the first lumen is configured for delivering at least one medication or medical tool to a position distal from the distal end of the elongated member (see Para. [0056] and [0081] mentioning wherein lumen 112 may be used to deliver wire 107 or other medical device to the distal end of the catheter).
Regarding claim 6, the combination of Ravikumar and Ben-Abraham disclose the invention of claim 1, Ravikumar, as modified by Ben-Abraham, further discloses an eighth of the plurality of lumens extending to an eighth opening a the distal end of the elongated member for positioned at least one fourth sensor (the additional sensing lumen extending to a corresponding aperture distally to the first balloon are defined as the “eighth lumen” and “eighth opening” respectively; see Examiner’s Diagram of Ravikumar Fig. 15A above for location reference).
Regarding claim 8, the combination of Ravikumar and Ben-Abraham disclose the invention of claim 1, Ravikumar further discloses wherein at least two of the plurality of lumens are parallel to each other in a side-by-side arrangement (lumens 112 and 114A are understood to be parallel to one-another along the length of the catheter body as they extend from the proximal hub to the distal-most region of the catheter body).
Regarding claim 9, the combination of Ravikumar and Ben-Abraham disclose the invention of claim 1, Ravikumar further discloses wherein at least two of the plurality of lumens are in a coaxial arrangement (lumens 112 and 114A are understood to be coaxial to one-another along the length of the catheter body as they extend from the proximal hub to the distal-most region of the catheter body).
Regarding claim 10, Ravikumar discloses:
A system for blocking a passageway, the system comprising:
a catheter (see Fig. 15A) configured for insertion into a passageway (see Para. [0010]-[0014] and [0019]), the catheter comprising:
an elongated member (catheter shaft 102, see Fig. 15A) with a plurality of lumens therein (see Para. [0054]-[0055] mentioning a plurality of inflation lumens (112, 114A, 114B, 114C, 114D) extending through the catheter body; see also Fig. 15A), the elongated member having a distal end and a proximal end defining a length of the elongated member (see Fig. 15A), a first of the plurality of lumens extending to a first opening at the distal end of the elongated member (lumen 112 receiving wire 107 therein, see Para. [0081] and Fig. 15A);
a first inflatable balloon disposed about the elongated member adjacent the distal end (balloon 104A, see Fig. 15A), a second of the plurality of lumens (lumen 114A, see Fig. 15A) extending to a second opening at an interior of the first inflatable balloon for inflating the first inflatable balloon (see Para. [0084]);
a second inflatable balloon (balloon 104B, see Fig. 15A) disposed about the elongated member at a position proximal from the first inflatable balloon (see Fig. 15A) forming a first gap between the first inflatable balloon and the second inflatable balloon (see Fig. 15A showing a gap along the catheter body between balloons 104A and 104B), a third of the plurality of lumens extending to a third opening at an interior of the second inflatable balloon for inflating the second inflatable balloon (lumen 114B, see Fig. 15A);
a first inflation device in fluid communication with the second lumen, the first inflation device configured to deliver a first fluid into the second lumen to inflate the first inflatable balloon and block fluid flow in the passageway (see Para. [0055] mentioning wherein the lumen 114A is in fluid communication with port 108A used to delivery an inflation media (i.e., from an inflation device) to the first balloon 104A); and
a second inflation device in fluid communication with the third lumen, the second inflation device configured to deliver a second fluid into the second lumen to inflate the second inflatable balloon and block fluid flow in the passageway (see Para. [0055] mentioning wherein the lumen 114B is in fluid communication with port 108B used to delivery an inflation media (i.e., from an inflation device) to the second balloon 104B).
However, Ravikumar does not expressly disclose:
a fourth of the plurality of lumens extending to a fourth opening in the first gap in which at least one first sensor is positioned that is configured to detect fluid characteristics proximal from the first inflatable balloon; and
a fifth of the plurality of lumens extending to a fifth opening at a position proximal from the second inflatable balloon in which at least one first sensor is positioned that is configured to detect fluid characteristics proximal from the first inflatable balloon; and
In the same field of endeavor, namely occluding balloon catheters configured to be used within the vasculature and through the vena cava to occlude and isolate portions of a desired vessel/artery, Ben-Abraham teaches wherein an occluding balloon catheter device (see Fig. 2), configured to isolate a desired portion of the aortic vasculature/vena cava, comprising a first balloon (expandable member 32, see Fig. 2) and a second balloon (expandable member 30, see Fig. 2) may comprise separate inflation lumens to separately inflate both balloons (see Para. [0069]); the catheter may further comprise additional sensing lumens (see Para. [0070] and Figs. 3-4 showing sensing lumens 40, 42, 44 and 46) that extend from the proximal hub of the device (see Para. [0076]) and are configured to allow sensing members (76, 78, 80 and 82) to extend therethrough (see Para. [0070]) up to a respective aperture (66, 68, 72, 74, see Figs. 5-6); wherein said respective sensing apertures are positioned such that one aperture is located proximally of each balloon and another aperture is located distally of each balloon (see Figs. 5-6 and Para. [0070], [0079] and [0083]) to measure fluid pressure and/or any other physiological parameter present at locations both proximally and distally of each expandable member (see Para. [0023] and [0083]) which allows a user to check for blood flow/pressure at locations both proximally and distally to each balloon to determine whether a desired occlusion type within the desired working site has been achieved (see Para. [0095]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the vasculature occluding balloon catheter of Ravikumar to comprise additional lumens extending from the proximal handle to respective apertures both proximally and distally of each balloon that are configured to receive fluid sensor members within each of said respective apertures as taught and suggested by Ben-Abraham to, in this case, measure fluid characteristics (i.e., blood pressure of blood flow) at locations both proximally and distally of each balloon to determine blood flow and/or blood pressure at locations proximally and distally of the respective balloons (see Ben-Abraham Para. [0070], [0079], [0083] and [0095]). Since the balloons of Ravikumar are configured to inflate sequentially in order to isolate a target vessel location (see Ravikumar Para. [0060]-[0063]), the sensor members would allow a user to determine whether each balloon has effectively occluded the target vessel area before inflating the other balloons in sequence. The additional sensing lumen extending to a corresponding aperture within the gap between the first and second balloons are defined as the “fourth lumen” and “fourth opening” respectively (see Examiner’s Diagram of Ravikumar Fig. 15A below for location reference). The additional sensing lumen extending to a corresponding aperture proximal to the second balloon are defined as the “fifth lumen” and “fifth opening” respectively (see Examiner’s Diagram of Ravikumar Fig. 15A below for location reference).
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Examiner’s Diagram of Ravikumar Fig. 15A
Regarding claim 12, the combination of Ravikumar and Ben-Abraham disclose the invention of claim 10, Ravikumar, as modified by Ben-Abraham, further discloses:
wherein the catheter further comprises:
a third inflatable balloon (balloon 104C, see Ravikumar Fig. 15A) disposed about the elongated member at a position proximal from the second inflatable balloon (see Ravikumar Fig. 15A) forming a second gap between the second inflatable balloon and the third inflatable balloon (see Ravikumar Fig. 15A showing a gap between balloons 104B and 104C), a sixth of the plurality of lumens (lumen 114C, see Ravikumar Para. [0054]-[0055]) extending to a sixth opening at an interior of the third inflatable balloon (see Ravikumar Para. [0054]-[0055]) for inflating the third inflatable balloon (see Ravikumar Para. [0054]-[0055]); and
a seventh of the plurality of lumens extending to a seventh opening at a position proximal from the third inflatable balloon in which at least one third sensor is positioned that is configured to detect fluid characteristics proximal from the third inflatable balloon, the at least one third sensor is configured to measure fluid characteristics in the passageway (the additional sensing lumen of Ravikumar, as incorporated from the teachings of Ben-Abraham, extending to a corresponding aperture proximal to the third balloon are defined as the “seventh lumen” and “seventh opening” respectively; see Examiner’s Diagram of Ravikumar Fig. 15A above for location reference);
wherein the fifth opening is positioned in the second gap (the “fifth opening” of Ravikumar, as incorporated from the teachings of Ben-Abraham and located proximal to second balloon is disposed within the gap between the second balloon 104B and third balloon 104C; see Examiner’s Diagram of Ravikumar Fig. 15A above for location reference).
Regarding claim 13, the combination of Ravikumar and Ben-Abraham disclose the invention of claim 12, Ravikumar further discloses a third inflation device in fluid communication with the sixth lumen, the third inflation device configured to deliver a third fluid into the sixth lumen to inflate the third inflatable balloon and block fluid flow in the passageway (see Para. [0055] mentioning wherein the lumen 114C is in fluid communication with port 108C used to delivery an inflation media (i.e., from an inflation device) to the third balloon 104C).
Regarding claim 14, the combination of Ravikumar and Ben-Abraham disclose the invention of claim 12, Ravikumar, as modified by Ben-Abraham, further discloses wherein each of the at least one first sensor, the at least one second sensor, and the at least one third sensor comprises pressure transducers, ultrasound transducers, sonic tips, flow sensors, or combinations thereof (see Ben-Abraham Para. [0090] mentioning wherein the sensor members may be comprised of flow sensors).
Regarding claim 15, the combination of Ravikumar and Ben-Abraham disclose the invention of claim 12, Ravikumar, as modified by Ben-Abraham, further discloses wherein the catheter further comprises an eighth of the plurality of lumens extending to an eighth opening at the distal end of the elongated member for positioning at least one fourth sensor (the additional sensing lumen extending to a corresponding aperture distally to the first balloon are defined as the “eighth lumen” and “eighth opening” respectively; see Examiner’s Diagram of Ravikumar Fig. 15A above for location reference).
Regarding claim 17, Ravikumar discloses:
A method for blocking a passageway, the method comprising:
inserting a catheter (see Fig. 15A) into a passageway (see Para. [0010]-[0014] and [0019]), the catheter comprising:
an elongated member (catheter shaft 102, see Fig. 15A) with a plurality of lumens therein (see Para. [0054]-[0055] mentioning a plurality of inflation lumens (112, 114A, 114B, 114C, 114D) extending through the catheter body; see also Fig. 15A), the elongated member having a distal end and a proximal end defining a length of the elongated member (see Fig. 15A), a first of the plurality of lumens extending to a first opening at the distal end of the elongated member (lumen 112 receiving wire 107 therein, see Para. [0081] and Fig. 15A);
a first inflatable balloon disposed about the elongated member adjacent the distal end (balloon 104A, see Fig. 15A), a second of the plurality of lumens (lumen 114A, see Fig. 15A) extending to a second opening at an interior of the first inflatable balloon for inflating the first inflatable balloon (see Para. [0084]);
a second inflatable balloon (balloon 104B, see Fig. 15A) disposed about the elongated member at a position proximal from the first inflatable balloon (see Fig. 15A) forming a first gap between the first inflatable balloon and the second inflatable balloon (see Fig. 15A showing a gap along the catheter body between balloons 104A and 104B), a third of the plurality of lumens (lumen 114B, see Fig. 15A) extending to a third opening at an interior of the second inflatable balloon for inflating the second inflatable balloon (see Para. [0084]);
positioning the catheter in the passageway such that the distal end of the elongated member is adjacent a desired location (see Para. [0010]-[0015], [0019] and [0060]-[0063]); and
inflating, via a first inflation device in fluid communication with the first inflatable balloon (see Para. [0055] mentioning wherein the lumen 114A is in fluid communication with port 108A used to delivery an inflation media (i.e., from an inflation device) to the first balloon 104A), the first inflatable balloon with a first fluid to block fluid flow in the passageway (see Para. [0060]-[0063] mentioning wherein balloon 104A is inflated before any of the other more proximal balloons within a target vessel).
inflating, via a second inflation device in fluid communication with the second inflatable balloon (see Para. [0055] mentioning wherein the lumen 114B is in fluid communication with port 108B used to delivery an inflation media (i.e., from an inflation device) to the second balloon 104B), the second inflatable balloon with a second fluid to block fluid flow in the passageway (see Para. [0060]-[0063]).
However, Ravikumar does not expressly disclose:
a fourth of the plurality of lumens extending to a fourth opening in the first gap in which at least one first sensor is positioned that is configured to detect fluid characteristics proximal from the first inflatable balloon; and
a fifth of the plurality of lumens extending to a fifth opening at a position proximal from the second inflatable balloon in which at least one second sensor is positioned that is configured to detect fluid characteristics proximal from the second inflatable balloon;
wherein each of the at least one first sensor and the at least one second sensor are configured to measure fluid characteristics in the passageway;
detecting, via the at least one first sensor, fluid characteristics in the passageway adjacent the first inflatable balloon;
assessing fluid characteristics data received from the at least one first sensor; and
inflating, via the second inflation device in fluid communication with the second inflatable balloon, the second inflatable balloon with a second fluid to block fluid flow in the passageway if the fluid characteristics adjacent the first inflatable balloon reaches a predetermined threshold.
In the same field of endeavor, namely occluding balloon catheters configured to be used within the vasculature and through the vena cava to occlude and isolate portions of a desired vessel/artery, Ben-Abraham teaches wherein an occluding balloon catheter device (see Fig. 2), configured to isolate a desired portion of the aortic vasculature/vena cava, comprising a first balloon (expandable member 32, see Fig. 2) and a second balloon (expandable member 30, see Fig. 2) may comprise separate inflation lumens to separately inflate both balloons (see Para. [0069]); the catheter may further comprise additional sensing lumens (see Para. [0070] and Figs. 3-4 showing sensing lumens 40, 42, 44 and 46) that extend from the proximal hub of the device (see Para. [0076]) and are configured to allow sensing members (76, 78, 80 and 82) to extend therethrough (see Para. [0070]) up to a respective aperture (66, 68, 72, 74, see Figs. 5-6); wherein said respective sensing apertures are positioned such that one aperture is located proximally of each balloon and another aperture is located distally of each balloon (see Figs. 5-6 and Para. [0070], [0079] and [0083]) to measure fluid pressure and/or any other physiological parameter present at locations both proximally and distally of each expandable member (see Para. [0023] and [0083]) which allows a user to check for blood flow/pressure at locations both proximally and distally to each balloon to determine whether a desired occlusion type within the desired working site has been achieved (see Para. [0095]).
Ben-Abraham further teaches wherein the sensors may be utilized to determine whether a fluid parameter exceeds a predetermined threshold and, if so, a processor unit may communicate with a pump mechanism to expand either one or both (i.e., all) expandable members to avoid harming the patient (see Para. [0093]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the vasculature occluding balloon catheter of Ravikumar to comprise additional lumens extending from the proximal handle to respective apertures both proximally and distally of each balloon that are configured to receive fluid sensor members within each of said respective apertures as taught and suggested by Ben-Abraham to, in this case, measure fluid characteristics (i.e., blood pressure of blood flow) at locations both proximally and distally of each balloon to determine blood flow and/or blood pressure at locations proximally and distally of the respective balloons (see Ben-Abraham Para. [0070], [0079], [0083] and [0095]) and, if a measured fluid parameter exceeds a predetermined threshold a processor unit may communicate with a pump mechanism to expand either one or both (i.e., all) expandable members to avoid harming the patient (see Ben-Abraham Para. [0093]). Since the balloons of Ravikumar are configured to inflate sequentially in order to isolate a target vessel location (see Ravikumar Para. [0060]-[0063]), the sensor members would allow a user to determine whether each balloon has effectively occluded the target vessel area before inflating the other balloons in sequence. The additional sensing lumen extending to a corresponding aperture within the gap between the first and second balloons are defined as the “fourth lumen” and “fourth opening” respectively (see Examiner’s Diagram of Ravikumar Fig. 15A below for location reference). The additional sensing lumen extending to a corresponding aperture proximal to the second balloon are defined as the “fifth lumen” and “fifth opening” respectively (see Examiner’s Diagram of Ravikumar Fig. 15A below for location reference).
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Examiner’s Diagram of Ravikumar Fig. 15A
Regarding claim 19, the combination of Ravikumar and Ben-Abraham disclose the method of claim 17, Ravikumar, as modified by Ben-Abraham, further discloses:
wherein the catheter further comprises:
a third inflatable balloon (balloon 104C, see Ravikumar Fig. 15A) disposed about the elongated member at a position proximal from the second inflatable balloon (see Ravikumar Fig. 15A) forming a second gap between the second inflatable balloon and the third inflatable balloon (see Ravikumar Fig. 15A showing a gap between balloons 104B and 104C), a sixth of the plurality of lumens (lumen 114C, see Ravikumar Para. [0054]-[0055]) extending to a sixth opening at an interior of the third inflatable balloon for inflating the third inflatable balloon (see Ravikumar Para. [0054]-[0055]); and
a seventh of the plurality of lumens extending to a seventh opening at a position proximal from the third inflatable balloon in which at least one third sensor is positioned that is configured to detect fluid characteristics proximal from the third inflatable balloon, the at least one third sensor is configured to measure fluid characteristics in the passageway (the additional sensing lumen of Ravikumar, as incorporated from the teachings of Ben-Abraham, extending to a corresponding aperture proximal to the third balloon are defined as the “seventh lumen” and “seventh opening” respectively; see Examiner’s Diagram of Ravikumar Fig. 15A above for location reference);
wherein the fifth opening is positioned in the second gap (the “fifth opening” of Ravikumar, as incorporated from the teachings of Ben-Abraham and located proximal to second balloon is disposed within the gap between the second balloon 104B and third balloon 104C; see Examiner’s Diagram of Ravikumar Fig. 15A above for location reference).
Regarding claim 20, the combination of Ravikumar and Ben-Abraham disclose the method of claim 19, Ravikumar, as modified by Ben-Abraham, further discloses detecting, via the at least one second sensor, fluid characteristics in the passageway adjacent the second inflatable balloon (see Ben-Abraham Para. [0083]); assessing fluid characteristics data received from the at least one second sensor (see Ben-Abraham Para. [0083] and [0093] mentioning wherein fluid data is sent to a processor for processing); and inflating, via a third inflation device in fluid communication with the third inflatable balloon, the third inflatable balloon with a third fluid to block fluid flow in the passageway if the fluid characteristics adjacent the second inflatable balloon reaches a predetermined threshold (see Ben-Abraham Para. [0093] mentioning wherein, if a fluid parameter exceeds a predetermined threshold, monitored by any of the sensor elements, the processor may communicate with a pump mechanism to expand either one or both (i.e., all) expandable members to avoid harming the patient).
Regarding claim 21, the combination of Ravikumar and Ben-Abraham disclose the method of claim 20, Ravikumar, as modified by Ben-Abraham, further discloses detecting, via the at least one third sensor, fluid characteristics in the passageway adjacent the third inflatable balloon (see Ben-Abraham Para. [0083]); and assessing fluid characteristics data received from the at least one third sensor to monitor for the fluid characteristics adjacent the third inflatable balloon reaching a predetermined threshold (see Ben-Abraham Para. [0093] mentioning wherein this is the purpose of the sensor members so as to prevent abnormal fluid flow within the target vessel).
Claim(s) 7 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ravikumar (US 2024/0090901 A1), in view of Ben-Abraham (US 2025/0099744 A1) (previously of record), further view of Fischer (US 2017/0189644 A1)(previously of record).
Regarding claim 7, the combination of Ravikumar and Ben-Abraham disclose all of the limitations of the invention of claim 1.
However, none of either Ravikumar or Ben-Abraham expressly disclose a ninth of the plurality of lumens extending at least partially through the elongated member for receiving a stiffening member therein.
In the same field of endeavor, namely balloon catheter devices configured to be navigated through the vasculature, Fischer teaches wherein a balloon catheter (see Fig. 1) may comprise an additional lumen (lumen 30, see Fig. 2) extending through the catheter body (see Fig. 2) configured to receive a stiffening member (31, see Fig. 2) therein to increase the stiffness of the catheter shaft (see Para. [0064]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the catheter of Ravikumar to include an additional lumen within the elongate body thereof to receive a stiffener member therein as taught and suggested by Fischer to, in this case, provide increased stiffness to the catheter shaft during navigation through the vasculature (see Fischer Para. [0064]).
Regarding claim 16, the combination of Ravikumar and Ben-Abraham disclose all of the limitations of the invention of claim 10.
However, none of either Ravikumar or Ben-Abraham expressly disclose a ninth of the plurality of lumens extending at least partially through the elongated member for receiving a stiffening member therein.
In the same field of endeavor, namely balloon catheter devices configured to be navigated through the vasculature, Fischer teaches wherein a balloon catheter (see Fig. 1) may comprise an additional lumen (lumen 30, see Fig. 2) extending through the catheter body (see Fig. 2) configured to receive a stiffening member (31, see Fig. 2) therein to increase the stiffness of the catheter shaft (see Para. [0064]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the catheter of Ravikumar to include an additional lumen within the elongate body thereof to receive a stiffener member therein as taught and suggested by Fischer to, in this case, provide increased stiffness to the catheter shaft during navigation through the vasculature (see Fischer Para. [0064]).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ravikumar (US 2024/0090901 A1), in view of Ben-Abraham (US 2025/0099744 A1) (previously of record), further view of Kumbhari (US 2015/0150572 A1).
Regarding claim 22, the combination of Ravikumar and Ben-Abraham disclose all of the limitations of the method of claim 17.
However, none of either Ravikumar or Ben-Abraham expressly disclose a method for the removal of a clot or other obstruction from the vasculature and thus do not expressly disclose:
wherein the catheter is positioned in the passageway such that the first inflatable balloon is positioned distal from an obstruction in the passageway and the second inflatable balloon is positioned proximal from the obstruction;
the method further comprising:
inflating, via a second inflation device in fluid communication with the second inflatable balloon, the second inflatable balloon with a second fluid to trap the obstruction in the first gap between the first inflatable balloon and the second inflatable balloon; and
removing the catheter from the passageway with the obstruction trapped in the first gap.
In the same field of endeavor of balloon catheters configured to provide treatment within a target vessel, Kumbhari teaches a method utilizing a balloon catheter to remove an occlusion from a vessel comprising steps inserting a balloon catheter (see Fig. 1A) into a target vessel such that a first balloon (balloon 28, see Fig. 1A) is positioned distally of the obstruction of the vessel (see Para. [0009]) and wherein a second balloon is positioned proximally of the obstruction of the vessel (see Para. [0009]) such that the obstruction is positioned between the two balloons (see Para. [0009]), wherein the first and second balloons are then inflated, trapping the obstruction between the two inflated balloons (see Para. [0009]), allowing the catheter device to be withdrawn from the current vessel to be captured or treated thereafter (see Para. [0009] mentioning wherein withdrawing the catheter allows the obstruction to enter a larger area within the body, thus “treating” and removing the obstruction from the target vessel).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized the device of Ravikumar, as modified by Ben-Abraham, in a method of removing an occlusion from a vessel comprising steps of positioning the first balloon distally of the clot/lesion, positioning the second balloon distally of the clot/lesion, inflating both the first and second balloon to trap the clot/lesion within the gap disposed between the first and second balloon before withdrawing the catheter and trapped clot/lesion as taught and suggested by Kumbhari to, in this case, provide a known method of utilizing an occlusion balloon catheter to remove a clot/lesion.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2019/0307462 A1 to Franklin, US 2024/0285908 A1 to Martin and US 2010/0280451 A1 to Teeslink all disclose multi-balloon catheters having a gap between each balloon and a method of treating and/or removing of the treated clot/lesion thereafter.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771