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 .
Formal Matters
Applicant’s Response filed 30 January 2026 is acknowledged. Claims 2 and 18 are cancelled. Claims 1, 4, 6, 17, and 19 are currently amended. Claims 1, 3-17, 19 and 20 are pending and under examination.
Claim Objections/Rejections Withdrawn
The objection to claim 20 because of the following informalities: a conjunction, such as an “and” is missing in claim 20, line 14 between the two “wherein” clauses, is withdrawn in light of Applicant’s amendment.
The rejection of claims 1 and 7-16 under 35 U.S.C. 103 as being unpatentable over Saadat et al., US 11,376,028 (5 July 2022) in view of Bonnette et al., US 20140155830 (5 June 2014), are withdrawn in light of Applicant’s Arguments and Amendments. Modified rejections are set forth below.
The rejection of claims 2-6 under 35 U.S.C. 103 as being unpatentable over Saadat et al., US 11,376,028 (5 July 2022) in view of Bonnette et al., US 20140155830 (5 June 2014) in further view of Caldron WO 2023092042 A1 (25 May 2023), are withdrawn in light of Applicant’s Arguments and Amendments. Modified rejections are set forth below.
The rejection of claim 17 under 35 U.S.C. 103 as being unpatentable over Saadat et al., US 11,376,028 (5 July 2022) in view of Bonnette et al., US 20140155830 (5 June 2014) and further in view of Saadat et al., US 20220409223 (29 December 2022) (hereinafter Saadat ‘223), is withdrawn in light of Applicant’s Arguments and Amendments. Modified rejections are set forth below.
The rejection of claims 18-20 under 35 U.S.C. 103 as being unpatentable over Saadat et al., US 11,376,028 (5 July 2022) in view of Bonnette et al., US 20140155830 (5 June 2014), Saadat et al., US 20220409223 (29 December 2022) (hereinafter Saadat ‘223), and further in view of Caldron WO 2023092042 A1 (25 May 2023), are withdrawn in light of Applicant’s Arguments and Amendments. Modified rejections are set forth below.
Response to Arguments
Applicant argues that claim 1 has been amended to incorporate the subject matter of claim 2 and the subject matter of claim 18 has been incorporated into claim 17. Applicant argues that the Saadat and Bonnette do not teach the limitation of now-cancelled claim 2. Applicant argues that Calderon does not overcome the teachings (Remarks, numbered pages 6-7). Applicant argues that “Caldron does not teach a fluid supply tube configured to shift between a first position and a second position, but rather teaches a fluid column within the vacuum channel 3 of the vacuum tube 2 is moved a shift distance based on a force applied by the compression roller to the vacuum tube 2” (Remarks numbered p. 6-7).
Applicant argues that Calderon teaches a fluid column within the vacuum channel 3 of vacuum tube 2 and the shift distance is based on a force applied by the compression of roller 60 to vacuum tube 2 (Remarks, numbered page 7). Applicant also traverses the rejection of claim 17 over Saadat ’028, Bonnette, and Saadat ‘223 (Remarks, numbered pages 7-8). Applicant argues that the cancellation of claim 18 renders the rejection of claims 18-20 moot.
Applicant’s arguments have been fully considered, but they are not persuasive.
Regarding Applicant’s argument that “Caldron does not teach a fluid supply tube configured to shift between a first position and a second position, but rather teaches a fluid column within the vacuum channel 3 of the vacuum tube 2 is moved a shift distance based on a force applied by the compression roller to the vacuum tube 2”, at ¶206, Caldron specifically discloses that “[i]n a procedure where the vacuum tube 2 is used in a thrombectomy, the vacuum channel 3 will be filled with a fluid, i.e., blood. When the vacuum channel 3 is completely occluded, the blood that fills up the vacuum channel 3 from the contact point 67 of the compression roller 60 distally to the distal end of the vacuum channel 3 defines a column of fluid, which fluid is not compressible. The controller 10 is configured to apply the extrusion compressor 50 and the compression roller 60 to move this column of fluid a shift distance 70 in the distal direction.” This aspect of Caldron uses a controller (10) and a compression roller to shift the fluid in a fluid-filled tube.
Additionally, Caldron expressly explains at ¶241 that “[b]oth a vacuum line 402 and a vent line 404 are connected through the selectively openable valves 420, 440 to a proximal end of the aspiration catheter 410. In operation, the vacuum cam 430 and the vent cam 450 push down on the respective cam followers 421 , which pinch down the short sections of tubing 426, 446, each respectively fluidically connected to the vacuum line 402 and the vent line 404. When the vacuum line 402 and the vent line 404 is closed, vacuum is drawn on the aspiration catheter 410. When the distal end of the catheter 410 is clogged with a clot, the closure raises a vacuum level within the catheter 410 to full (the greatest current vacuum generated by the vacuum pump). This closure creates a delta in pressure between the internal lumen of the catheter 410 and the environment external to the catheter 410, which change squeezes down the body of the catheter 410 both radially and longitudinally (e.g., the diameter and length become incrementally smaller). This change also draws out a small volume of liquid from within the lumen of the catheter 410. In some embodiments, the volume is approximately 0.2 ml. The end effect is the creation of a spring-like force within the catheter 410 that wants to expand the catheter 410 back to its steady state, but when the vacuum line 402 is closed off, that cannot happen. Thus, the vacuum is stored as potential energy until the vent line 404 is opened (as can be seen in FIG. 26, for example, the vacuum and vent lines 402, 404 are connected together distal of the valves 420, 440).” This “squeeze down” has the same physical effect as that of the compression roller of ¶206 in that it generates a shift in the tube.
The disclosure of Caldron demonstrates the shifting movement from a first position to a second position of a fluid-filled tube based on the innate physical properties of fluid dynamics and vacuums on tubes. The movement of the tube is both an innate physical property of vacuum pressure and the material composition of the tube.
Caldron expressly demonstrates the shifting of a fluid tube because the pressure differential creates suction at the distal end of the catheter and results in a change in the body of catheter 410 both radially and longitudinally due to pressure changes (deltas) between the internal lumen and the environment external to the lumen that results in the diameter and length becoming incrementally smaller. This longitudinal shift in length moves the tube proximally when a vacuum is pulled, compared to when the vacuum is released, such that the pressure is released and the tube returns to its original state in the absence of significant pressure differentials (¶241). The final position of the tube, both proximally and distally, and the degree of change (delta) is a function of the vacuum pressure which depends on the configuration of the vacuum and the material and physical properties of the tube itself.
Further, at ¶15, Caldron teaches that aspiration thrombectomy systems are known to clog and one of the express purposes of the disclosure of Caldron is to prevent such clogging and to provide a means by which to unclog catheters after being clogged temporarily, by halting the vacuum at the distal end of the aspiration catheter, reversing a fluid column in the catheter (such as the fluid supply tube taught by Bonnette or the fluid-filled tube taught by Caldron at ¶206) in order to push the thrombus distally relative to the catheter, and then reapplying vacuum in a short period of time such that the clot material is recaptured by the vacuum before the clot material is ejected uncontrollably from the distal end of the catheter.
Based on the express teachings of the combination of Caldron and Bonnette, one of ordinary skill in the art, knowing that the clogging of aspiration catheters was a common problem, both with regular thrombus and the “more difficult and strong thrombus and lesions”, as taught by Bonnette, would be motivated to utilize existing methods and the solution of Caldron, rather than redesigning a whole new system. Whether the property of vacuum pressure shift dislodgement is implemented in a fluid-filled vacuum line as taught by Caldron or any other kind of fluid-filled line, such as a fluid supply tube, as taught by Bonnette, the innate physical property of shifts in tubes due to pressure differentials between the internal lumen and the environment external to the lumen that results in the diameter and length becoming incrementally smaller (Caldron, ¶241). Vacuum properties are physical properties that remain the same. One need only apply it to one type of fluid-filled tube or another. The teaching, suggestion, and motivation to use the innate physical property for the purpose of unclogging aspiration catheters is expressly provided in Caldron and Bonnette.
Applicant’s amendments require modified rejections, necessitated by amendment as set forth below.
New Claim Objections – Necessitated by Amendment
Claim 19 is objected to because of the following informalities: claim 19 is drawn to an aspiration catheter, but has been amended to depend from claim 17, which is drawn to a thrombectomy system. Appropriate correction is required.
Modified Claim Rejections – Necessitated by Amendment
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 3-16 are rejected under 35 U.S.C. 103 as being unpatentable over Saadat et al., US 11,376,028 (5 July 2022) (hereinafter “Saadat ‘028) in view of Bonnette et al., US 20140155830 (5 June 2014) and further in view of Caldron WO 2023092042 A1 (25 May 2023) (all previously cited of record).
Regarding independent claim 1, Saadat teaches an aspiration catheter (treatment system 1100, col 24, lines 11-28; FIGs 11A-E), comprising:
a catheter body (24) having a proximal end region, a distal end region (1100) and a lumen extending therein (FIGs 11A-E; col 24, ln 13-15);
a funnel (capture structure 100) having a proximal end and a distal end (FIGs 11A-E), wherein the proximal end is coupled (fluidly coupled, Abstract) to the distal end region (col 24, ln 13-15; FIGs 11A-E) of the catheter body (24), and
wherein the funnel is configured to shift between a collapsed configuration and an expanded configuration (FIG 11b; col 24, ln 19-20).
Saadat does not teach a fluid supply tube extending within the lumen of the catheter body, the fluid supply tube having a distal end region and a distal facing surface.
Bonnette teaches a thrombectomy aspiration catheter (Abstract; FIG 17) comprising a fluid supply tube (FIGs 17, 18; fluid jet emanator 52C) extending within the lumen of the catheter body (FIG 18, catheter tube 12c) and the fluid supply tube having a distal end region and a distal facing surface (FIGs 17, 18; ¶104).
Neither Saadat ‘028 nor Bonnette teach wherein the fluid supply tube is configured to shift between a first position in which the distal end region is positioned proximal of the proximal end of the funnel and a second position in which the distal end region is positioned distal of the proximal end of the funnel.
Caldron teaches aspiration catheter 410 with vacuum line 402 and vent line 404 (¶241) wherein the fluid supply tube 402 is configured to shift (diameter and length become incrementally smaller; shift distance 70, ¶206) between a first position (vacuum line 402 is open and vent line 404 is closed; a vacuum is drawn on aspiration catheter 410) and a second position (vacuum line 402 is open and vent line 404 is open; vacuum is released) in which the distal end region is positioned distal of the proximal end of the funnel (¶241).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Saadat ‘028, Bonnette, and Caldron, given that the prior art included each element claimed, although not necessarily in a single reference.
Saadat ‘028, Bonnette, and Caldron all teach in the field of aspiration catheters for removal of thrombus lesions within a blood vessel.
Although, Saadat ‘028 discloses the claimed base aspiration catheter with a funnel, Saadat ‘028 does not disclose that the aspiration catheter comprises a fluid supply tube within the lumen of the catheter body.
Bonnette specifically addresses thrombectomy aspiration catheters comprising a fluid supply tube extending within the lumen of the catheter body (FIGs 17, 18; fluid jet emanator 52C). Bonnette also addressed the motivation for the combination by including directed fluid jet streams that impinge upon and ablate difficult and strong thrombus and lesions within a blood vessel (Abstract), providing an explicit motivation for the combination.
Neither Saadat ‘028 nor Bonnette teach wherein the fluid supply tube is configured to shift between a first position in which the distal end region is positioned proximal of the proximal end of the funnel and a second position in which the distal end region is positioned distal of the proximal end of the funnel.
Caldron discloses aspiration catheters with a vacuum line and a vent line comprising a fluid supply tube configured to shift (diameter and length become incrementally smaller; shift distance 70, ¶206) between a first position and a second position in which the distal end region is positioned distal of the proximal end of the funnel (¶241). Caldron expressly discloses that when vacuum line 402 is open and vent line 404 is closed, a vacuum is drawn on aspiration catheter 410 and the closure creates a delta in pressure between the internal lumen of the catheter 410 and the environment external to the catheter 410, which change squeezes down the body of the catheter 410 both radially and longitudinally (e.g., the diameter and length become incrementally smaller). When the vent line 404 is opened, there is an in-rush of fluid because of the pressure delta. This rush of fluid balances the radial force of the catheter 410 and draws in fluid to create a distally directed momentum in the column of fluid residing in the catheter 410 distal of the valves 420, 440 (¶241).
Caldron teaches that the shifting of the supply tube is inherent in the vacuum process where a vacuum is drawn on the catheter in light of an open vacuum line and a closed vent line. The pressure differential creates suction at the distal end of the catheter and results in a change in the body of catheter 410 both radially and longitudinally due to pressure changes (deltas) between the internal lumen and the environment external to the lumen that results in the diameter and length becoming incrementally smaller. This longitudinal shift in length moves the tube proximally when a vacuum is pulled compared to when the vacuum is released, such that the pressure is released and the tube returns to its original state in the absence of significant pressure differentials. The movement of the tube is both an innate physical property of vacuum pressure and the material composition of the tube. The more slack provided by the tube, based on its physical/material components the greater the movement when vacuum pressure is applied. The final position of the tube, both proximally and distally, and the degree of change (delta) is a function of the vacuum pressure which depends on the configuration of the vacuum and the material and physical properties of the tube itself. One of ordinary skill in the art would also be motivated to automate the procedure to improve process and make it faster and more controllable.
Caldron expressly demonstrates the shifting of a fluid tube is because the pressure differential creates suction at the distal end of the catheter and results in a change in the body of catheter 410 both radially and longitudinally due to pressure changes (deltas) between the internal lumen and the environment external to the lumen that results in the diameter and length becoming incrementally smaller. This longitudinal shift in length moves the tube proximally when a vacuum is pulled, compared to when the vacuum is released, such that the pressure is released and the tube returns to its original state in the absence of significant pressure differentials (¶241). The final position of the tube, both proximally and distally, and the degree of change (delta) is a function of the vacuum pressure which depends on the configuration of the vacuum and the material and physical properties of the tube itself.
Further, at ¶15, Caldron teaches that aspiration thrombectomy systems are known to clog and one of the express purposes of the disclosure of Caldron is to prevent such clogging and to provide a means by which to unclog catheters after being clogged temporarily, by halting the vacuum at the distal end of the aspiration catheter, reversing a fluid column in the catheter (such as the fluid supply tube taught by Bonnette or the fluid-filled tube taught by Caldron at ¶206) in order to push the thrombus distally relative to the catheter, and then reapplying vacuum in a short period of time such that the clot material is recaptured by the vacuum before the clot material is ejected uncontrollably from the distal end of the catheter.
Based on the express teachings of the combination of Caldron and Bonnette, one of ordinary skill in the art, knowing that the clogging of aspiration catheters was a common problem, both with regular thrombus and the “more difficult and strong thrombus and lesions”, as taught by Bonnette, would be motivated to utilize existing methods and the solution of Caldron, rather than redesigning a whole new system. Whether the property of vacuum pressure shift dislodgement is implemented in a fluid-filled vacuum line as taught by Caldron or any other kind of fluid-filled line, such as a fluid supply tube, as taught by Bonnette, the innate physical property of shifts in tubes due to pressure differentials between the internal lumen and the environment external to the lumen that results in the diameter and length becoming incrementally smaller (Caldron, ¶241). Vacuum properties are physical properties that remain the same. One need only apply it to one type of fluid-filled tube or another. The teaching, suggestion, and motivation to use the innate physical property for the purpose of unclogging aspiration catheters is expressly provided in Caldron and Bonnette.
Based on the express teachings of Caldron and Bonnette, one of ordinary skill in the art, knowing that the clogging of aspiration catheters was a common problem, both with regular and “more difficult and strong thrombus and lesions”, as taught by Bonnette, would be motivated to utilize existing methods in clot removal systems (aspiration catheters using vacuum systems) rather than redesigning a whole new system. The vacuum roller system of Caldron, while being more primitive than, for example, an automated vacuum pump controller, is effective in unclogging aspiration thrombectomy catheters by utilizing an innate physical property of fluid dynamics and fluid flow in a vacuum. Whether the property of vacuum pressure dislodgement is implemented in a fluid-based vacuum line as taught by Caldron or a fluid supply tube as taught by Bonnette, the innate physical fluidic vacuum property remains the same. One need only apply it to one type of fluid-filled tube or another. The teaching, suggestion, and motivation to use the innate physical property for the purpose of unclogging aspiration catheters is expressly provided in Caldron and Bonnette.
A person of ordinary skill in the art attempting to render Saadat ‘028’s base device compatible to impinge upon and ablate difficult and strong thrombus and lesions within a blood vessel, as disclosed by Bonnette, would look for established catheter designs that ameliorate clogs or occlusions of the catheter that are a risk when ablating difficult and strong thrombus lesions within a blood vessel. Calderon’s movable fluid lines use a differential pressure delta to expressly avoid blockage and occlusions, the structural components that drive this effect are modular and can be readily adapted to the aspiration catheter of Saadat ‘028 and Bonnette enable a fluid supply tube that shifts between a first and second position around the proximal end of the funnel without redesigning Saadat ‘028’s and Bonnette’s core aspiration catheters.
Because Saadat ‘028, Bonnette, and Caldron address the same engineering problem (providing aspiration catheters that impinge upon and ablate difficult and strong thrombus and lesions within a blood vessel) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a fluid supply tube within the lumen of the catheter body and a means to create a pressure differential in a fluid supply line of an aspiration catheter), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Applicant is reminded that the recitation of an element that is “configured to” perform a function is not necessarily a positive limitation, but only requires the ability to so perform. See In re Hutchison, 69 USPQ 138, 33 CCPA 879 (1946). Accordingly, absent evidence to the contrary, the aspiration catheters of Saadat ‘028, Bonnette, and Caldron have the ability for the fluid supply tube to shift between a first position in which the distal end region is positioned proximal of the proximal end of the funnel and a second position in which the distal end region is positioned distal of the proximal end of the funnel.
Regarding claim 3, Saadat ‘028 modified by Bonnette and Caldron teaches the aspiration catheter of claim 1, as set forth above, for the reasons set forth above.
Caldron teaches aspiration catheter 410 with vacuum line 402 and vent line 404 (¶241) wherein the fluid supply tube 402 is configured to shift (diameter and length become incrementally smaller; shift distance 70, ¶206) between a first position (vacuum line 402 is open and vent line 404 is closed; a vacuum is drawn on aspiration catheter 410) in which the distal end region is positioned proximal of the proximal end of the funnel and a second position (vacuum line 402 is open and vent line 404 is open; vacuum is released) in which the distal end region is positioned between the distal of the proximal end of the funnel (¶241).
Caldron teaches that when vacuum line 402 is open and vent line 404 is closed, a vacuum is drawn on aspiration catheter 410 and the closure creates a delta in pressure between the internal lumen of the catheter 410 and the environment external to the catheter 410, which change squeezes down the body of the catheter 410 both radially and longitudinally (e.g., the diameter and length become incrementally smaller). When the vent line 404 is opened, there is an in-rush of fluid because of the pressure delta. This rush of fluid balances the radial force of the catheter 410 and draws in fluid to create a distally directed momentum in the column of fluid residing in the catheter 410 distal of the valves 420, 440 (¶241).
Caldron teaches that the shifting of the supply tube is inherent in the vacuum process where a vacuum is drawn on the catheter in light of an open vacuum line and a closed vent line. The pressure differential creates suction at the distal end of the catheter and results in a change in the body of catheter 410 both radially and longitudinally due to pressure changes (deltas) between the internal lumen and the environment external to the lumen that results in the diameter and length becoming incrementally smaller. This longitudinal shift in length moves the tube proximally when a vacuum is pulled compared to when the vacuum is released, such that the pressure is released and the tube returns to its original state in the absence of significant pressure differentials. The movement of the tube is both an innate physical property of vacuum pressure and the material composition of the tube. The more slack provided by the tube, based on its physical/material components the greater the movement when vacuum pressure is applied. The final position of the tube, both proximally and distally, and the degree of change (delta) is a function of the vacuum pressure which depends on the configuration of the vacuum and the material and physical properties of the tube itself.
Regarding claim 4, Saadat ‘028 modified by Bonnette and Caldron teaches the aspiration catheter of claim 1, as set forth above, for the reasons set forth above.
Caldron teaches wherein the proximal end region of the catheter body 410 is coupled to a fluid pump 80 (Abstract), and wherein the fluid pump 80 is configured to cycle (vacuum timing cycle, ¶¶241, 263; claim 6) between applying a vacuum and ceasing to apply the vacuum (Abstract; claim 1), and wherein the fluid supply tube 402 shifts (shift distance 70, ¶206) between the first position (vacuum line 402 is open and vent line 404 is closed; a vacuum is drawn on aspiration catheter 410) and the second position (vacuum line 402 is open and vent line 404 is open; vacuum is released) based on the vacuum cycle of the fluid pump 80 (Abstract; ¶241; claim 1).
Caldron teaches that when vacuum line 402 is open and vent line 404 is closed, a vacuum is drawn on aspiration catheter 410 and the closure creates a delta in pressure between the internal lumen of the catheter 410 and the environment external to the catheter 410, which change squeezes down the body of the catheter 410 both radially and longitudinally (e.g., the diameter and length become incrementally smaller). When the vent line 404 is opened, there is an in-rush of fluid because of the pressure delta. This rush of fluid balances the radial force of the catheter 410 and draws in fluid to create a distally directed momentum in the column of fluid residing in the catheter 410 distal of the valves 420, 440 (¶241).
Caldron teaches that the shifting of the supply tube is inherent in the vacuum process where a vacuum is drawn on the catheter in light of an open vacuum line and a closed vent line. The pressure differential creates suction at the distal end of the catheter and results in a change in the body of catheter 410 both radially and longitudinally due to pressure changes (deltas) between the internal lumen and the environment external to the lumen that results in the diameter and length becoming incrementally smaller. This longitudinal shift in length moves the tube proximally when a vacuum is pulled compared to when the vacuum is released, such that the pressure is released and the tube returns to its original state in the absence of significant pressure differentials. The movement of the tube is both an innate physical property of vacuum pressure and the material composition of the tube. The more slack provided by the tube, based on its physical/material components the greater the movement when vacuum pressure is applied. The final position of the tube, both proximally and distally, and the degree of change (delta) is a function of the vacuum pressure which depends on the configuration of the vacuum and the material and physical properties of the tube itself. One of ordinary skill in the art would be motivated to automate the procedure based on the vacuum pump cycle to improve process and make it faster and more controllable.
Regarding claim 5, Saadat ‘028 modified by Bonnette and Caldron teaches the aspiration catheter of claim 4, as set forth above, for the reasons set forth above.
Caldron teaches wherein the fluid supply tube 402 is configured to shift (shift distance 70, ¶206) from a first position (vacuum line 402 is open and vent line 404 is closed; a vacuum is drawn on aspiration catheter 410) and a second position (vacuum line 402 is open and vent line 404 is open; vacuum is released) when the fluid pump 80 is in a downstroke (vacuum timing cycle, ¶¶241, 263; claim 6), and wherein the fluid supply tube 402 is configured to shift (shift distance 70, ¶206) from the second position to the first position when the fluid pump 80 is in an upstroke (vacuum timing cycle, ¶¶241, 263; claim 6).
Caldron teaches that when vacuum line 402 is open and vent line 404 is closed, a vacuum is drawn on aspiration catheter 410 and the closure creates a delta in pressure between the internal lumen of the catheter 410 and the environment external to the catheter 410, which change squeezes down the body of the catheter 410 both radially and longitudinally (e.g., the diameter and length become incrementally smaller). When the vent line 404 is opened, there is an in-rush of fluid because of the pressure delta. This rush of fluid balances the radial force of the catheter 410 and draws in fluid to create a distally directed momentum in the column of fluid residing in the catheter 410 distal of the valves 420, 440 (¶241).
Caldron teaches that the shifting of the supply tube is inherent in the vacuum process where a vacuum is drawn on the catheter in light of an open vacuum line and a closed vent line. The pressure differential creates suction at the distal end of the catheter and results in a change in the body of catheter 410 both radially and longitudinally due to pressure changes (deltas) between the internal lumen and the environment external to the lumen that results in the diameter and length becoming incrementally smaller. This longitudinal shift in length moves the tube proximally when a vacuum is pulled compared to when the vacuum is released, such that the pressure is released and the tube returns to its original state in the absence of significant pressure differentials. The movement of the tube is both an innate physical property of vacuum pressure and the material composition of the tube. The more slack provided by the tube, based on its physical/material components the greater the movement when vacuum pressure is applied. The final position of the tube, both proximally and distally, and the degree of change (delta) is a function of the vacuum pressure which depends on the configuration of the vacuum and the material and physical properties of the tube itself. One of ordinary skill in the art would be motivated to automate the procedure based on the vacuum pump cycle, including the downstroke and upstroke, to improve process and make it faster and more controllable.
Regarding claim 6, Saadat ‘028 modified by Bonnette and Caldron teaches the aspiration catheter of claim 2, as set forth above, for the reasons set forth above.
Caldron teaches wherein when the fluid supply tube 402 is in the second position, the distal facing surface is between 0 mm and 20 mm distal of the proximal end (shift distance 70, approximately 0.5mm to approximately 30mm; ¶206).
Regarding claim 7, Saadat ‘028 modified by Bonnette and Caldron teaches the aspiration catheter of claim 1, as set forth above, for the reasons set forth above.
Saadat ‘028 also teaches wherein when in the expanded configuration the funnel 100 tapers from a first diameter at its proximal end to a second diameter at its distal end (FIG 11E), and wherein the second diameter is greater than the first diameter (FIG 11E).
Regarding claim 8, Saadat ‘028 modified by Bonnette and Caldron teaches the aspiration catheter of claim 1, as set forth above, for the reasons set forth above.
Saadat ‘028 also teaches wherein the funnel 100 includes a plurality of braided filaments (braided wire) (col 17, lines 14-16).
Regarding claim 9, Saadat ‘028 modified by Bonnette and Caldron teaches the aspiration catheter of claim 1, as set forth above, for the reasons set forth above.
Saadat ‘028 also teaches embodiment 1200 wherein funnel 100 includes at least one reinforcing member (disruptor 200), and wherein the at least one reinforcing member extends from a proximal end of the funnel to a distal end of the funnel (col 24, lines 41-47).
The multiple embodiments in Saadat provide a teaching, suggestion, or motivation in the reference itself, as a whole, and in the knowledge generally available to one of ordinary skill in the art, to combine reference teachings with a reasonable expectation of success. The claimed invention would have been obvious because a person of ordinary skill in the art would have been motivated to combine teachings within the four corners of a reference to achieve the claimed invention with a reasonable expectation of success. Saadat teaches different embodiments each solving known problems in the art, including providing synergistically reinforcing elements (disruptor 200) along with the primary capture structure 100, as taught in embodiment 1100. Saadat teaches that the capture structure 100 and the disruptor 200 work synergistically to capture and process obstructive material so that the obstructive material can be removed from the patient through the system 1200. One of ordinary skill in the art would be motivated to select among the various embodiments of Saadat depending on the anatomical location of the thrombus and the nature of the thrombus to be removed. One would have a reasonable expectation of success in selecting from the finite embodiments taught by Saadat that are best suited for the particular clinical situation.
Regarding claim 10, Saadat ‘028 modified by Bonnette and Caldron teaches the aspiration catheter of claim 1, as set forth above, for the reasons set forth above.
Saadat also teaches wherein the funnel 100 is configured to direct thrombus into the lumen of the catheter shaft 24 (FIGs 11A-E; col 24, lines 19-28).
Regarding claim 11, Saadat ‘028 modified by Bonnette and Caldron teaches the aspiration catheter of claim 1, as set forth above, for the reasons set forth above.
Saadat also teaches wherein when in the expanded configuration (FIGs 11B-11E) the distal end region of the funnel 100 is configured to engage an inner surface of a body vessel (FIGs 11B-11E).
Regarding claim 12, Saadat ‘028 modified by Bonnette and Caldron teaches the aspiration catheter of claim 1, as set forth above, for the reasons set forth above.
Bonnette also teaches the thrombectomy aspiration catheter (FIG 18), further comprising at least one projection (high pressure tube 50) extending distally away from the distal facing surface of the fluid supply tube (FIGs 17, 18; 52C).
Regarding claim 13, Saadat ‘028 modified by Bonnette and Caldron teaches the aspiration catheter of claim 1, as set forth above, for the reasons set forth above.
Bonnette also teaches wherein the fluid supply tube (FIG 17, 52C) includes at least one distally projecting jet orifice (122a-122n) for expelling at least one distally oriented fluid jet in a generally distal direction from the fluid supply tube (FIGs 17, 18; 52C) within the catheter lumen or funnel (FIGs 17, 18).
Regarding claim 14, Saadat ‘028 modified by Bonnette and Caldron teaches the aspiration catheter of claim 13, as set forth above, for the reasons set forth above.
Bonnette also teaches wherein the fluid supply tube (FIG 17, 52C) includes at least one proximally projecting jet orifice (106a-106n) for expelling at least one proximally oriented fluid jet in a generally proximal direction from the fluid supply tube (FIGs 17, 18; 52C) within the catheter lumen or funnel (FIGs 17, 18).
Regarding claim 15, Saadat ‘028 modified by Bonnette and Caldron teaches the aspiration catheter of claim 14, as set forth above, for the reasons set forth above.
Bonnette also teaches wherein the at least one distally projecting jet orifice (122a-122n) is distal to the at least one proximally projecting jet orifice (106a-106n) (FIGs 17, 18).
Regarding claim 16, Saadat ‘028 modified by Bonnette and Caldron teaches the aspiration catheter of claim 13, as set forth above, for the reasons set forth above.
Bonnette also teaches wherein the at least one distally projecting jet orifice (122a-122n) extends through a sidewall of the fluid supply tube (annotated FIG 17).
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Bonnette, annotated Figure 17
Claims 17, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Saadat et al., US 11,376,028 (5 July 2022) (hereinafter Saadat ‘028) in view of Bonnette et al., US 20140155830 (5 June 2014), Saadat et al., US 20220409223 (29 December 2022) (hereinafter Saadat ‘223), and further in view of Caldron WO 2023092042 A1 (25 May 2023) (all previously cited of record).
Regarding independent claim 17, Saadat ‘028 teaches a thrombectomy system (treatment system 1100, col 24, lines 11-28; FIGs 11A-E), comprising:
a thrombectomy catheter (FIGs 11A-E; 24),
wherein the thrombectomy catheter (24) includes:
a catheter body having a proximal end region (24),
a distal end region and a lumen extending therein (24); and
a funnel (capture structure 100) having a proximal end and a distal end (FIGs 11A-E),
wherein the proximal end is coupled (fluidly coupled, Abstract) to the distal end region (col 24, ln 13-15; FIGs 11A-E) of the catheter body (24), and
wherein the funnel is configured to shift between a collapsed configuration and an expanded configuration (FIG 11b; col 24, ln 19-20).
Saadat ‘028 does not teach a processor coupled to a fluid pump, a fluid supply tube extending within the lumen of the catheter body, or the fluid supply tube having a distal end region and a distal facing surface.
Saadat ‘028 does not teach that the aspiration catheter comprises a fluid supply tube within the lumen of the catheter body.
Bonnette teaches a thrombectomy aspiration catheter (Abstract; FIG 17) comprising a fluid supply tube (FIGs 17, 18; fluid jet emanator 52C) extending within the lumen of the catheter body (FIG 18, catheter tube 12c) and the fluid supply tube having a distal end region and a distal facing surface (FIGs 17, 18; ¶104).
Bonnette does not teach a processor coupled to a fluid pump.
Saadat ‘223 teaches aspiration systems for clot removal (Abstract) comprising “one or more processors within the controller may control the application of suction through the suction catheter, by controlling a pump directly and/or indirectly (e.g., using one or more valves, etc.)” (¶33).
Neither Saadat ‘028, Bonnette, nor Saadat ‘223 teach wherein the fluid supply tube is configured to shift between a first position in which the distal end region is positioned proximal of the proximal end of the funnel and a second position in which the distal end region is positioned distal of the proximal end of the funnel.
Caldron teaches aspiration catheter 410 with vacuum line 402 and vent line 404 (¶241) wherein the fluid supply tube 402 is configured to shift (diameter and length become incrementally smaller; shift distance 70, ¶206) between a first position (vacuum line 402 is open and vent line 404 is closed; a vacuum is drawn on aspiration catheter 410) and a second position (vacuum line 402 is open and vent line 404 is open; vacuum is released) in which the distal end region is positioned distal of the proximal end of the funnel (¶241).
Caldron expressly teaches that when vacuum line 402 is open and vent line 404 is closed, a vacuum is drawn on aspiration catheter 410 and the closure creates a delta in pressure between the internal lumen of the catheter 410 and the environment external to the catheter 410, which change squeezes down the body of the catheter 410 both radially and longitudinally (e.g., the diameter and length become incrementally smaller). When the vent line 404 is opened, there is an in-rush of fluid because of the pressure delta. This rush of fluid balances the radial force of the catheter 410 and draws in fluid to create a distally directed momentum in the column of fluid residing in the catheter 410 distal of the valves 420, 440 (¶241).
Caldron teaches that the shifting of the supply tube is inherent in the vacuum process where a vacuum is drawn on the catheter in light of an open vacuum line and a closed vent line. The pressure differential creates suction at the distal end of the catheter and results in a change in the body of catheter 410 both radially and longitudinally due to pressure changes (deltas) between the internal lumen and the environment external to the lumen that results in the diameter and length becoming incrementally smaller. This longitudinal shift in length moves the tube proximally when a vacuum is pulled compared to when the vacuum is released, such that the pressure is released and the tube returns to its original state in the absence of significant pressure differentials. The movement of the tube is both an innate physical property of vacuum pressure and the material composition of the tube. The more slack provided by the tube, based on its physical/material components the greater the movement when vacuum pressure is applied. The final position of the tube, both proximally and distally, and the degree of change (delta) is a function of the vacuum pressure which depends on the configuration of the vacuum and the material and physical properties of the tube itself. One of ordinary skill in the art would be motivated to automate the procedure to improve process and make it faster and more controllable.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Saadat ‘028, Bonnette, and Calderone, given that the prior art included each element claimed, although not necessarily in a single reference.
Saadat ‘028, Bonnette, and Caldron all teach in the field of aspiration catheters for removal of thrombus lesions within a blood vessel.
Although, Saadat ‘028 discloses the claimed base aspiration catheter with a funnel, Saadat ‘028 does not disclose that the aspiration catheter comprises a fluid supply tube within the lumen of the catheter body, that the catheter comprises a processor, or that the fluid supply tube is configured to shift between a first position in which the distal end region is positioned proximal of the proximal end of the funnel and a second position in which the distal end region is positioned distal of the proximal end of the funnel.
Bonnette specifically addresses thrombectomy aspiration catheters comprising a fluid supply tube extending within the lumen of the catheter body (FIGs 17, 18; fluid jet emanator 52C). Bonnette also addressed the motivation for the combination by including directed fluid jet streams that impinge upon and ablate difficult and strong thrombus and lesions within a blood vessel (Abstract), providing an explicit motivation for the combination.
Saadat ‘223 specifically addresses that one or more processors within the controller may control the application of suction through the suction catheter, by controlling a pump directly and/or indirectly.
Caldron specifically discloses that aspiration catheters with a vacuum line and a vent line comprising a fluid supply tube configured to shift (diameter and length become incrementally smaller; shift distance 70, ¶206) between a first position and a second position in which the distal end region is positioned distal of the proximal end of the funnel (¶241). Caldron expressly discloses that when vacuum line 402 is open and vent line 404 is closed, a vacuum is drawn on aspiration catheter 410 and the closure creates a delta in pressure between the internal lumen of the catheter 410 and the environment external to the catheter 410, which change squeezes down the body of the catheter 410 both radially and longitudinally (e.g., the diameter and length become incrementally smaller). When the vent line 404 is opened, there is an in-rush of fluid because of the pressure delta. This rush of fluid balances the radial force of the catheter 410 and draws in fluid to create a distally directed momentum in the column of fluid residing in the catheter 410 distal of the valves 420, 440 (¶241).
Caldron teaches that the shifting of the supply tube is inherent in the vacuum process where a vacuum is drawn on the catheter in light of an open vacuum line and a closed vent line. The pressure differential creates suction at the distal end of the catheter and results in a change in the body of catheter 410 both radially and longitudinally due to pressure changes (deltas) between the internal lumen and the environment external to the lumen that results in the diameter and length becoming incrementally smaller. This longitudinal shift in length moves the tube proximally when a vacuum is pulled compared to when the vacuum is released, such that the pressure is released and the tube returns to its original state in the absence of significant pressure differentials. The movement of the tube is both an innate physical property of vacuum pressure and the material composition of the tube. The more slack provided by the tube, based on its physical/material components the greater the movement when vacuum pressure is applied. The final position of the tube, both proximally and distally, and the degree of change (delta) is a function of the vacuum pressure which depends on the configuration of the vacuum and the material and physical properties of the tube itself. One of ordinary skill in the art would be motivated to automate the procedure to improve process and make it faster and more controllable.
Caldron expressly demonstrates the shifting of a fluid tube is because the pressure differential creates suction at the distal end of the catheter and results in a change in the body of catheter 410 both radially and longitudinally due to pressure changes (deltas) between the internal lumen and the environment external to the lumen that results in the diameter and length becoming incrementally smaller. This longitudinal shift in length moves the tube proximally when a vacuum is pulled, compared to when the vacuum is released, such that the pressure is released and the tube returns to its original state in the absence of significant pressure differentials (¶241). The final position of the tube, both proximally and distally, and the degree of change (delta) is a function of the vacuum pressure which depends on the configuration of the vacuum and the material and physical properties of the tube itself.
Further, at ¶15, Caldron teaches that aspiration thrombectomy systems are known to clog and one of the express purposes of the disclosure of Caldron is to prevent such clogging and to provide a means by which to unclog catheters after being clogged temporarily, by halting the vacuum at the distal end of the aspiration catheter, reversing a fluid column in the catheter (such as the fluid supply tube taught by Bonnette or the fluid-filled tube taught by Caldron at ¶206) in order to push the thrombus distally relative to the catheter, and then reapplying vacuum in a short period of time such that the clot material is recaptured by the vacuum before the clot material is ejected uncontrollably from the distal end of the catheter.
Based on the express teachings of the combination of Caldron and Bonnette, one of ordinary skill in the art, knowing that the clogging of aspiration catheters was a common problem, both with regular thrombus and the “more difficult and strong thrombus and lesions”, as taught by Bonnette, would be motivated to utilize existing methods and the solution of Caldron, rather than redesigning a whole new system. Whether the property of vacuum pressure shift dislodgement is implemented in a fluid-filled vacuum line as taught by Caldron or any other kind of fluid-filled line, such as a fluid supply tube, as taught by Bonnette, the innate physical property of shifts in tubes due to pressure differentials between the internal lumen and the environment external to the lumen that results in the diameter and length becoming incrementally smaller (Caldron, ¶241). Vacuum properties are physical properties that remain the same. One need only apply it to one type of fluid-filled tube or another. The teaching, suggestion, and motivation to use the innate physical property for the purpose of unclogging aspiration catheters is expressly provided in Caldron and Bonnette. Applicant is reminded that the references are combinatorial and should be considered together.
A person of ordinary skill in the art attempting to render Saadat ‘028’s base device compatible to impinge upon and ablate difficult and strong thrombus and lesions within a blood vessel, as disclosed by Bonnette, would look for established catheter designs that ameliorate clogs or occlusions of the catheter that are a risk when ablating difficult and strong thrombus lesions within a blood vessel. Calderon’s movable fluid lines use a differential pressure delta to expressly avoid blockage and occlusions, the structural components that drive this effect are modular and can be readily adapted to the aspiration catheter of Saadat ‘028 and Bonnette enable a fluid supply tube that shifts between a first and second position around the proximal end of the funnel without redesigning Saadat ‘028’s and Bonnette’s core aspiration catheters. Additionally, one of ordinary skill in the art looking to automate the process of suction through the catheter in a pulsatile manner to prevent occlusions of the catheter would look to the established solutions of Saadat ‘223, by incorporating one or more processors within the controller in order to control the application of suction through the suction catheter, by controlling a vacuum pump directly and/or indirectly. One of ordinary skill in the art would be motivated to automate the procedure to improve process and make it faster, more controllable, and more likely to remove occlusive material from the catheter.
Because Saadat ‘028, Bonnette, Saadat ‘223, and Caldron address the same engineering problem (providing aspiration catheters that impinge upon and ablate difficult and strong thrombus and lesions within a blood vessel) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a fluid supply tube within the lumen of the catheter body and an automated means by which to create a pressure differential in a fluid supply line of an aspiration catheter), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Applicant is reminded that the recitation of an element that is “configured to” perform a function is not necessarily a positive limitation, but only requires the ability to so perform. See In re Hutchison, 69 USPQ 138, 33 CCPA 879 (1946). Accordingly, absent evidence to the contrary, the aspiration catheters of Saadat ‘028, Bonnette, and Caldron have the ability for the fluid supply tube to shift between a first position in which the distal end region is positioned proximal of the proximal end of the funnel and a second position in which the distal end region is positioned distal of the proximal end of the funnel.
Regarding claim 19, Saadat ‘028 modified by Bonnette, Saadat ‘223, and Caldron teaches the aspiration catheter of claim 17, as set forth above, for the reasons set forth above.
Caldron teaches wherein the proximal end region of the catheter body 410 is coupled to a fluid pump 80 (Abstract), and wherein the fluid pump 80 is configured to cycle (vacuum timing cycle, ¶¶241, 263; claim 6), between applying a vacuum and ceasing to apply the vacuum (claims 1, 6) and wherein the fluid supply tube 402 shifts (shift distance 70, ¶206) between the first position (vacuum line 402 is open and vent line 404 is closed; a vacuum is drawn on aspiration catheter 410) and the second position based (vacuum line 402 is open and vent line 404 is open; vacuum is released) on the vacuum cycle of the fluid pump 80 (Abstract; ¶241; claim 1).
Caldron teaches that when vacuum line 402 is open and vent line 404 is closed, a vacuum is drawn on aspiration catheter 410 and the closure creates a delta in pressure between the internal lumen of the catheter 410 and the environment external to the catheter 410, which change squeezes down the body of the catheter 410 both radially and longitudinally (e.g., the diameter and length become incrementally smaller). When the vent line 404 is opened, there is an in-rush of fluid because of the pressure delta. This rush of fluid balances the radial force of the catheter 410 and draws in fluid to create a distally directed momentum in the column of fluid residing in the catheter 410 distal of the valves 420, 440 (¶241).
Caldron teaches that the shifting of the supply tube is inherent in the vacuum process where a vacuum is drawn on the catheter in light of an open vacuum line and a closed vent line. The pressure differential creates suction at the distal end of the catheter and results in a change in the body of catheter 410 both radially and longitudinally due to pressure changes (deltas) between the internal lumen and the environment external to the lumen that results in the diameter and length becoming incrementally smaller. This longitudinal shift in length moves the tube proximally when a vacuum is pulled compared to when the vacuum is released, such that the pressure is released and the tube returns to its original state in the absence of significant pressure differentials. The movement of the tube is both an innate physical property of vacuum pressure and the material composition of the tube. The more slack provided by the tube, based on its physical/material components the greater the movement when vacuum pressure is applied. The final position of the tube, both proximally and distally, and the degree of change (delta) is a function of the vacuum pressure which depends on the configuration of the vacuum and the material and physical properties of the tube itself. One of ordinary skill in the art would be motivated to automate the procedure based on the vacuum pump cycle to improve process and make it faster and more controllable.
Regarding amended independent claim 20, Saadat teaches a thrombectomy system (treatment system 1100, col 24, lines 11-28; FIGs 11A-E), comprising:
a thrombectomy catheter, wherein the thrombectomy catheter (FIGs 11A-E; 24), includes:
a catheter body having a proximal end region (24),
a distal end region and a lumen extending therein (24); and
a funnel (capture structure 100) having a proximal end and a distal end (FIGs 11A-E),
wherein the proximal end is coupled (fluidly coupled, Abstract) to the distal end region (col 24, ln 13-15; FIGs 11A-E) of the catheter body (24), and
wherein the funnel is configured to shift between a collapsed configuration and an expanded configuration (FIG 11b; col 24, ln 19-20);
Saadat does not teach a processor coupled to a fluid pump, a fluid supply tube extending within the lumen of the catheter body, or the fluid supply tube having a distal end region and a distal facing surface.
Bonnette teaches a thrombectomy aspiration catheter (Abstract; FIG 17) comprising a fluid supply tube (FIGs 17, 18; fluid jet emanator 52C) extending within the lumen of the catheter body (FIG 18, catheter tube 12c) and the fluid supply tube having a distal end region and a distal facing surface (FIGs 17, 18; ¶104).
Bonnette does not teach a processor coupled to a fluid pump.
Saadat ‘223 teaches aspiration systems for clot removal (Abstract) comprising “one or more processors within the controller may control the application of suction through the suction catheter, by controlling a pump directly and/or indirectly (e.g., using one or more valves, etc.) “ (¶33).
Saadat, Bonnette, and Saadat ‘223 do not teach wherein the fluid supply tube is configured to shift between a first position in which the distal end region is positioned proximal of the proximal end of the funnel and a second position in which the distal end region is positioned distal of the proximal end of the funnel; and wherein the fluid pump is configured to cycle between applying a vacuum and ceasing to apply the vacuum, and wherein the processor is configured to direct the fluid supply tube to shift between the first position and the second position based on the vacuum cycle of the fluid pump.
Caldron teaches wherein the proximal end region of the catheter body 410 is coupled to a fluid pump 80 (Abstract), and wherein the fluid pump 80 is configured to cycle (vacuum timing cycle, ¶¶241, 263; claim 6), between applying a vacuum and ceasing to apply the vacuum (claims 1, 6) and wherein the fluid supply tube 402 shifts (shift distance 70, ¶206) between the first position (vacuum line 402 is open and vent line 404 is closed; a vacuum is drawn on aspiration catheter 410) and the second position based (vacuum line 402 is open and vent line 404 is open; vacuum is released) on the vacuum cycle of the fluid pump 80 (Abstract; ¶241; claim 1).
Caldron expressly teaches that when vacuum line 402 is open and vent line 404 is closed, a vacuum is drawn on aspiration catheter 410 and the closure creates a delta in pressure between the internal lumen of the catheter 410 and the environment external to the catheter 410, which change squeezes down the body of the catheter 410 both radially and longitudinally (e.g., the diameter and length become incrementally smaller). When the vent line 404 is opened, there is an in-rush of fluid because of the pressure delta. This rush of fluid balances the radial force of the catheter 410 and draws in fluid to create a distally directed momentum in the column of fluid residing in the catheter 410 distal of the valves 420, 440 (¶241).
Caldron teaches that the shifting of the supply tube is inherent in the vacuum process where a vacuum is drawn on the catheter in light of an open vacuum line and a closed vent line. The pressure differential creates suction at the distal end of the catheter and results in a change in the body of catheter 410 both radially and longitudinally due to pressure changes (deltas) between the internal lumen and the environment external to the lumen that results in the diameter and length becoming incrementally smaller. This longitudinal shift in length moves the tube proximally when a vacuum is pulled compared to when the vacuum is released, such that the pressure is released and the tube returns to its original state in the absence of significant pressure differentials. The movement of the tube is both an innate physical property of vacuum pressure and the material composition of the tube. The more slack provided by the tube, based on its physical/material components the greater the movement when vacuum pressure is applied. The final position of the tube, both proximally and distally, and the degree of change (delta) is a function of the vacuum pressure which depends on the configuration of the vacuum and the material and physical properties of the tube itself. One of ordinary skill in the art would be motivated to automate the procedure to improve process and make it faster and more controllable.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Saadat ‘028, Bonnette, and Calderone, given that the prior art included each element claimed, although not necessarily in a single reference.
Saadat ‘028, Bonnette, and Caldron all teach in the field of aspiration catheters for removal of thrombus lesions within a blood vessel.
Although, Saadat ‘028 discloses the claimed base aspiration catheter with a funnel, Saadat ‘028 does not disclose that the aspiration catheter comprises a fluid supply tube within the lumen of the catheter body, that the catheter comprises a processor, or that the fluid supply tube is configured to shift between a first position in which the distal end region is positioned proximal of the proximal end of the funnel and a second position in which the distal end region is positioned distal of the proximal end of the funnel.
Bonnette specifically addresses thrombectomy aspiration catheters comprising a fluid supply tube extending within the lumen of the catheter body (FIGs 17, 18; fluid jet emanator 52C). Bonnette also addressed the motivation for the combination by including directed fluid jet streams that impinge upon and ablate difficult and strong thrombus and lesions within a blood vessel (Abstract), providing an explicit motivation for the combination.
Saadat ‘223 specifically addresses that one or more processors within the controller may control the application of suction through the suction catheter, by controlling a pump directly and/or indirectly.
Caldron specifically discloses that aspiration catheters with a vacuum line and a vent line comprising a fluid supply tube configured to shift (diameter and length become incrementally smaller; shift distance 70, ¶206) between a first position and a second position in which the distal end region is positioned distal of the proximal end of the funnel (¶241). Caldron expressly discloses that when vacuum line 402 is open and vent line 404 is closed, a vacuum is drawn on aspiration catheter 410 and the closure creates a delta in pressure between the internal lumen of the catheter 410 and the environment external to the catheter 410, which change squeezes down the body of the catheter 410 both radially and longitudinally (e.g., the diameter and length become incrementally smaller). When the vent line 404 is opened, there is an in-rush of fluid because of the pressure delta. This rush of fluid balances the radial force of the catheter 410 and draws in fluid to create a distally directed momentum in the column of fluid residing in the catheter 410 distal of the valves 420, 440 (¶241).
Caldron expressly demonstrates the shifting of a fluid tube is because the pressure differential creates suction at the distal end of the catheter and results in a change in the body of catheter 410 both radially and longitudinally due to pressure changes (deltas) between the internal lumen and the environment external to the lumen that results in the diameter and length becoming incrementally smaller. This longitudinal shift in length moves the tube proximally when a vacuum is pulled, compared to when the vacuum is released, such that the pressure is released and the tube returns to its original state in the absence of significant pressure differentials (¶241). The final position of the tube, both proximally and distally, and the degree of change (delta) is a function of the vacuum pressure which depends on the configuration of the vacuum and the material and physical properties of the tube itself.
Further, at ¶15, Caldron teaches that aspiration thrombectomy systems are known to clog and one of the express purposes of the disclosure of Caldron is to prevent such clogging and to provide a means by which to unclog catheters after being clogged temporarily, by halting the vacuum at the distal end of the aspiration catheter, reversing a fluid column in the catheter (such as the fluid supply tube taught by Bonnette or the fluid-filled tube taught by Caldron at ¶206) in order to push the thrombus distally relative to the catheter, and then reapplying vacuum in a short period of time such that the clot material is recaptured by the vacuum before the clot material is ejected uncontrollably from the distal end of the catheter.
Based on the express teachings of the combination of Caldron and Bonnette, one of ordinary skill in the art, knowing that the clogging of aspiration catheters was a common problem, both with regular thrombus and the “more difficult and strong thrombus and lesions”, as taught by Bonnette, would be motivated to utilize existing methods and the solution of Caldron, rather than redesigning a whole new system. Whether the property of vacuum pressure shift dislodgement is implemented in a fluid-filled vacuum line as taught by Caldron or any other kind of fluid-filled line, such as a fluid supply tube, as taught by Bonnette, the innate physical property of shifts in tubes due to pressure differentials between the internal lumen and the environment external to the lumen that results in the diameter and length becoming incrementally smaller (Caldron, ¶241). Vacuum properties are physical properties that remain the same. One need only apply it to one type of fluid-filled tube or another. The teaching, suggestion, and motivation to use the innate physical property for the purpose of unclogging aspiration catheters is expressly provided in Caldron and Bonnette. Additionally, one of ordinary skill in the art would be motivated to automate the procedure based on the vacuum pump cycle to improve process and make it faster and more controllable.
A person of ordinary skill in the art attempting to render Saadat ‘028’s base device compatible to impinge upon and ablate difficult and strong thrombus and lesions within a blood vessel, as disclosed by Bonnette, would look for established catheter designs that ameliorate clogs or occlusions of the catheter that are a risk when ablating difficult and strong thrombus lesions within a blood vessel. Calderon’s movable fluid lines use a differential pressure delta to expressly avoid blockage and occlusions, the structural components that drive this effect are modular and can be readily adapted to the aspiration catheter of Saadat ‘028 and Bonnette enable a fluid supply tube that shifts between a first and second position around the proximal end of the funnel without redesigning Saadat ‘028’s and Bonnette’s core aspiration catheters. Additionally, one of ordinary skill in the art looking to automate the process of suction through the catheter in a pulsatile manner to prevent occlusions of the catheter would look to the established solutions of Saadat ‘223, by incorporating one or more processors within the controller in order to control the application of suction through the suction catheter, by controlling a vacuum pump directly and/or indirectly. One of ordinary skill in the art would be motivated to automate the procedure to improve process and make it faster, more controllable, and more likely to remove occlusive material from the catheter.
Because Saadat ‘028, Bonnette, Saadat ‘223, and Caldron address the same engineering problem (providing aspiration catheters that impinge upon and ablate difficult and strong thrombus and lesions within a blood vessel) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a fluid supply tube within the lumen of the catheter body and an automated means by which to create a pressure differential in a fluid supply line of an aspiration catheter), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Applicant is reminded that the recitation of an element that is “configured to” perform a function is not necessarily a positive limitation, but only requires the ability to so perform. See In re Hutchison, 69 USPQ 138, 33 CCPA 879 (1946). Accordingly, absent evidence to the contrary, the aspiration catheters of Saadat ‘028, Bonnette, and Caldron have the ability for the fluid supply tube to shift between a first position in which the distal end region is positioned proximal of the proximal end of the funnel and a second position in which the distal end region is positioned distal of the proximal end of the funnel.
Conclusion
No claim is allowed.
The prior art made of record and not presently relied upon is considered pertinent to applicant's disclosure:
Mintz, US 20220061872 (3 March 2022) teaches aspiration systems and methods and expanding mouth catheters.
Soni et al., US 20240008725 (11 January 2024, benefit to 11 July 2022).
Lombardi et al., US 20170035276 (9 February 2017) teaches disposable sheath devices.
Buster et al., US 20140378750 (25 December 2014) teaches device useful for recovering blastocysts from uterus of human, comprises outer guide and inner catheter.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-F 9am-6pm (CST).
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/CHERIE M POLAND/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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